xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06005233</url>
    </required_header>
    <id_info>
      <org_study_id>20230726</org_study_id>
      <nct_id>NCT06005233</nct_id>
    </id_info>
    <brief_title>Smartwatches for Detection of Atrial Fibrillation (AFib) in Secondary Prevention of Cryptogenic Stroke</brief_title>
    <acronym>WATCH AFib</acronym>
    <official_title>Smartwatches for Detection of Atrial Fibrillation (AFib) in Secondary Prevention of Cryptogenic Stroke - WATCH AFib A Prospective, Intraindividual-controlled, Multicenter Clinical Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Technical University of Munich</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Technical University of Munich</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Scientific Background: In secondary prevention of ischemic stroke, detection of atrial&#xD;
        fibrillation (AFib) and subsequent anticoagulation therapy reduce the risk of recurrent&#xD;
        stroke by approximately 60%. Prolonged electrocardiogram (ECG) monitoring up to 6 months&#xD;
        significantly increases detection of AFib in cryptogenic stroke. Wearables like smartwatches&#xD;
        have recently been shown to adequately detect AFib in the general population. Thus, prolonged&#xD;
        ECG monitoring after cryptogenic ischemic stroke or transient ischemic attack (TIA) using a&#xD;
        smartwatch could lead to a reduction of recurrent stroke by prompting adequate&#xD;
        anticoagulation therapy and may constitute a cost-effective, non-invasive, and&#xD;
        broadly-available alternative to the current standard of care.&#xD;
  &#xD;
        Hypothesis: The investigators hypothesize that AFib detection via smartwatch in patients with&#xD;
        cryptogenic TIA or ischemic stroke is accurate compared to an implantable event recorder.&#xD;
  &#xD;
        Methods: The investigators introduce a prospective, intraindividual-controlled, multicentre&#xD;
        clinical study in patients with cryptogenic ischemic stroke or TIA. In addition to an&#xD;
        implanted event recorder as indicated by clinical standard, included patients receive a&#xD;
        smartwatch for detection of AFib. ECG-data from smartwatches will be continuously monitored&#xD;
        by two independent cardiologists. As soon as AFib is confirmed, a doctoral appointment is set&#xD;
        to evaluate start of anticoagulation. The follow-up period will be six months. The study&#xD;
        consists of four study visits: a baseline visit, two phone visits at one and three months,&#xD;
        and an end of trial visit at six months.&#xD;
  &#xD;
        Primary Objective: To compare smartwatch and event recorder based analysis for sensitivity&#xD;
        and specificity of AFib detection per patient after six months&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Ischemic stroke is worldwide the second most frequent cause of death and disability and has a&#xD;
        lifetime risk of approximately 25%. In the secondary prevention of ischemic stroke, detection&#xD;
        of atrial fibrillation (AFib) and subsequent anticoagulation therapy reduce the risk of&#xD;
        recurrent stroke by approximately 60%. Cryptogenic stroke is defined as ischemic stroke for&#xD;
        which no probable cause is found despite a full standard evaluation and comprises 25% of all&#xD;
        ischemic strokes. Prolonged electrocardiogram (ECG) monitoring for 30 days to 6 months&#xD;
        significantly increases the detection of occult paroxysmal AFib in cryptogenic stroke, which&#xD;
        is present in 9 - 16%. Thus, prolonged ECG monitoring is likely to lead to a reduction of&#xD;
        recurrent stroke by prompting adequate anticoagulation therapy.&#xD;
  &#xD;
        Still, prolonged AFib screening after stroke is currently suboptimal due to a limitation of&#xD;
        resources, loss to follow-up, invasiveness of procedures, and costs. Wearables like&#xD;
        smartwatches have recently been shown to adequately detect AFib in the general population.&#xD;
        Sensitivity and specificity of AFib detection compared to ECG-based diagnosis is high (93-98%&#xD;
        and 90-98%, respectively). Compared to implantable Event Recorders, smartwatch based AFib&#xD;
        diagnosis in the general population exhibits a sensitivity of 97.5% for AFib episodes &gt;1h and&#xD;
        a sensitivity of 100% for AFib detection per patient.&#xD;
  &#xD;
        The investigators hypothesize that AFib detection via smartwatch in patients suffering from&#xD;
        cryptogenic transient ischemic attack (TIA) or ischemic stroke is accurate for AFib detection&#xD;
        compared to an implantable Event Recorder and might therefore be a non-invasive,&#xD;
        cost-effective, widely available alternative, which could potentially change the current&#xD;
        standard of post-stroke care.&#xD;
  &#xD;
        The primary objective is to assess whether AFib detection via smartwatch in patients&#xD;
        suffering from cryptogenic TIA/ ischemic stroke is accurate in comparison to implantable&#xD;
        Event Recorders. This will be assessed by sensitivity and specificity of AFib detection per&#xD;
        patient after six months. The investigators aim on a comparison of smartwatch based,&#xD;
        continuous, automated, cardiologist supervised rhythm analysis of photoplethysmography (PPG)-&#xD;
        signal and patient activated 1-lead ECG with Event Recorder based, continuous, automated ECG&#xD;
        rhythm analysis.&#xD;
  &#xD;
        This is a prospective, intraindividual-controlled, multicenter clinical study.&#xD;
  &#xD;
        The study population includes patients with cryptogenic TIA or ischemic stroke and known risk&#xD;
        factors for the presence of paroxysmal AFib (see inclusion criteria; CHA2DS2VASc score ≥4,&#xD;
        Atrial runs, Left atrial size &gt; 45mm, Left atrial appendage flow ≤ 0.2m/s).&#xD;
  &#xD;
        In addition to an implanted Event Recorder according to clinical standard, patients receive a&#xD;
        smartwatch. Smartwatch- and Event Recorder-derived heart rhythm are daily uploaded and&#xD;
        ana-lyzed by the cardiologists at the Cardiology Core Lab at the Department of Internal&#xD;
        Medicine I, Klinikum rechts der Isar, Munich. The obtained data on cardiac arrhythmia will be&#xD;
        assessable for each study site in consultation with the Cardiology Core Lab. In case of an&#xD;
        arrhythmic event, the obtained data on duration, source of information (e.g., smartwatch PPG&#xD;
        signal, smartwatch 1-lead ECG, Event Recorder) will be implemented in the eCRF by the&#xD;
        Cardiology Core Lab.&#xD;
  &#xD;
        In parallel, the study consists of a total of four visits. The baseline visit (Visit 0) may&#xD;
        take place within the clinical setting of the acute stroke work up. A table containing a&#xD;
        detailed plan of the data to be collected will be provided. Furtherly, the implementation and&#xD;
        set-up of the smart-watch will take place within the baseline visit. A manual will be&#xD;
        provided for each study center and patient to correctly set up and instruct on the usage of&#xD;
        the smartwatch. The second and third visit (Visit 1, Visit 2) constitute phone-visits at one&#xD;
        and three months with a tolerated time deviation of one week. The last visit at the end of&#xD;
        the study (Visit 3) will be performed at six months with a tolerated time deviation of three&#xD;
        weeks. This visit will take place at each pa-tient's study center. A table containing a&#xD;
        detailed plan of the data to be collected will be pro-vided for each study center.&#xD;
  &#xD;
        The first patient is planned to be included approximately in the third quarter of 2023 and&#xD;
        the last patient approximately in the first quarter of 2025. Accordingly, the last patient&#xD;
        will exit the study ('last patient last visit') approximately by the end of 2025.&#xD;
  &#xD;
        The clinical study will be carried out in accordance with the study protocol and the&#xD;
        principles of the Declaration of Helsinki by the World Medical Association and specific&#xD;
        applicable national ethical and regulatory requirements.&#xD;
  &#xD;
        All patients included in the clinical study will receive standard of care for cryptogenic&#xD;
        TIA/ is-chemic stroke. The clinical study protocol does not interfere with generally accepted&#xD;
        standards in post stroke care and local SOPs .The applied smartwatch is CE-certified as a&#xD;
        medical device for AFib detection. As the study intervention consists in simply wearing a&#xD;
        smartwatch (and phone visits are implemented at one and three months), we expect no safety&#xD;
        risk for study partici-pants.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">April 2026</completion_date>
    <primary_completion_date type="Anticipated">October 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>Prospective, intraindividual-controlled, multicenter clinical study.</intervention_model_description>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Sensitivity and Specificity of AFib Detection</measure>
      <time_frame>From baseline visit (V0) to the last follow-up at visit (V3) at six months</time_frame>
      <description>To estimate and compare sensitivity and specificity for AFib detection per patient after six months (Comparison of smartwatch based, continuous, automated, cardiologist supervised rhythm analysis of photoplethysmography (PPG)- signal and patient activated 1-lead ECG with Event Recorder based, continuous, automated ECG rhythm analysis).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>To estimate and compare the positive and negative predictive values for AFib detection per patient</measure>
      <time_frame>From baseline visit (V0) to the last follow-up at visit (V3) at six months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sensitivity and specificity for AFib detection of the automated PPG-signal rhythm analysis</measure>
      <time_frame>From baseline visit (V0) to the last follow-up at visit (V3) at six months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sensitivity and specificity for the detection of any AFib episode</measure>
      <time_frame>From baseline visit (V0) to the last follow-up at visit (V3) at six months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sensitivity for the detection of AFib episodes &gt;1 hour</measure>
      <time_frame>From baseline visit (V0) to the last follow-up at visit (V3) at six months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sensitivity and specificity of AFib detection per recorded/ per analyzable time (i.e., intervals in which the watch is actually worn/records an analyzable signal; per-protocol analysis)</measure>
      <time_frame>From baseline visit (V0) to the last follow-up at visit (V3) at six months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Specificity for episodes of sinus rhythms &gt;1 hour</measure>
      <time_frame>From baseline visit (V0) to the last follow-up at visit (V3) at six months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Stroke and TIA recurrence within six months</measure>
      <time_frame>From baseline visit (V0) to the last follow-up at visit (V3) at six months</time_frame>
      <description>Stroke or TIA recurrence in the clinical follop-up visits at 1, 3 and 6 months</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Subgroup analysis: accuracy in severely affected patients (i.e., National Institute of Health Stroke Scale (NIHSS) ≥8)</measure>
      <time_frame>From baseline visit (V0) to the last follow-up at visit (V3) at six months</time_frame>
      <description>NIHSS: 0-42 points, a higher score refers to the presence of more stroke related symtpoms/ worse outcome</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Exploratory endpoint: Acceptance and practicability of smartwatches for AFib detection</measure>
      <time_frame>From baseline visit (V0) to the last follow-up at visit (V3) at six months</time_frame>
      <description>self-designed questionnaire</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Exploratory endpoint: AFib burden/ patient</measure>
      <time_frame>From baseline visit (V0) to the last follow-up at visit (V3) at six months</time_frame>
      <description>Duration of AFib episodes/ Duration of Sinus rhythm</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Exploratory endpoint: relevance of AFib risk factors</measure>
      <time_frame>From baseline visit (V0) to the last follow-up at visit (V3) at six months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Exploratory endpoint: AFib detection rates after one month and after six months and time to confirmed AFib diagnosis</measure>
      <time_frame>From baseline visit (V0) to the last follow-up at visit (V3) at six months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Exploratory endpoint: count of AFib diagnoses</measure>
      <time_frame>From baseline visit (V0) to the last follow-up at visit (V3) at six months</time_frame>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">400</enrollment>
    <condition>Ischemic Stroke, Cryptogenic</condition>
    <condition>Transient Ischemic Attack</condition>
    <condition>Atrial Fibrillation</condition>
    <arm_group>
      <arm_group_label>Application of Smartwatch</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Application of smartwatch in addition to an implanted event recorder. Follow-up of 6 months</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Smartwatch</intervention_name>
      <description>Smartwatch with PPG- and 1-lead ECG derived analysis of cardiac arrhythmia. Analysis will be performed centrally at the Cardiology Core Lab at the Klinikum Rechts der Isar.</description>
      <arm_group_label>Application of Smartwatch</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Implanted Event Recorder with telemedicinal function (e.g., Biotronik BioMon 3m ProMRI&#xD;
               HomeMon or similar)&#xD;
  &#xD;
            -  Cryptogenic stroke (within the last six month) after full standard evaluation:&#xD;
  &#xD;
                 -  Stroke detected by computed tomography (CT) or magnetic resonance imaging (MRI)&#xD;
                    that is not lacunar (lacunar is defined as a subcortical infarct in the&#xD;
                    distribution of the small, penetrating cerebral arteries whose largest dimension&#xD;
                    is ≤1.5 cm on CT or ≤2.0 cm on MRI diffusion images)&#xD;
  &#xD;
                 -  Absence of extracranial or intracranial atherosclerosis causing ≥50 percent&#xD;
                    luminal stenosis of the artery supplying the area of ischemia&#xD;
  &#xD;
                 -  No major-risk cardioembolic source of embolism (i.e., no permanent or paroxysmal&#xD;
                    atrial fibrillation, sustained atrial flutter, intracardiac thrombus, prosthetic&#xD;
                    cardiac valve, atrial myxoma or other cardiac tumors, high-grade mitral valve&#xD;
                    stenosis, recent (within four weeks) myocardial infarction, left ventricular&#xD;
                    ejection fraction &lt;30 percent, valvular vegetations, or infective endocarditis)&#xD;
  &#xD;
                 -  No other specific cause of stroke identified (e.g., arteritis, dissection,&#xD;
                    migraine, vasospasm, drug abuse)&#xD;
  &#xD;
                 -  No paroxysmal atrial fibrillation in 72h of in-hospital ECG-monitoring, including&#xD;
                    at least one Holter- ECG for 24 hours.&#xD;
  &#xD;
            -  Cryptogenic TIA with definite cortical syndrome (aphasia, neglect or homonymous&#xD;
               hemianopia) (within the last six month) after full standard evaluation (see above)&#xD;
  &#xD;
            -  Age: ≥40 yrs.&#xD;
  &#xD;
            -  At least one of the following risk factors:&#xD;
  &#xD;
                 -  CHA2DS2VASc score ≥4&#xD;
  &#xD;
                 -  Atrial runs&#xD;
  &#xD;
                 -  Left atrial size &gt; 45mm&#xD;
  &#xD;
                 -  Left atrial appendage flow ≤ 0.2m/s&#xD;
  &#xD;
            -  No contraindication for anticoagulant therapy after acute phase of stroke&#xD;
  &#xD;
            -  Written informed consent by patient or authorized caregiver&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patient is not able to perform 1-lead ECG recording with smartwatch&#xD;
  &#xD;
            -  Patient possesses no smartphone (iOS version ≥10.0 or Android)&#xD;
  &#xD;
            -  Implanted pacemaker or cardioverter defibrillator (ICD)&#xD;
  &#xD;
            -  Pregnancy and breastfeeding period&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>40 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Silke Wunderlich, Dr.med</last_name>
      <phone>0049(0)8941404606</phone>
      <email>Silke.Wunderlich@tum.de</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Horst Penkert, Dr. med.</last_name>
      <phone>0049(0)8941404606</phone>
      <email>h.penkert@tum.de</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Klinikum rechts der Isar, Technische Universität München</name>
        <address>
          <city>Munich</city>
          <zip>81675</zip>
          <country>Germany</country>
        </address>
      </facility>
      <contact>
        <last_name>Silke Wunderlich, Dr. med.</last_name>
        <phone>0049(0)8941404606</phone>
        <email>silke.wunderlich@tum.de</email>
      </contact>
      <investigator>
        <last_name>Silke Wunderlich, Dr. med.</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Horst Penkert, Dr. med.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Eimo Martens, Dr. med</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Silvia Egert-Schwender, Dr.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Germany</country>
    </location_countries>
    <reference>
      <citation>GBD 2016 Neurology Collaborators. Global, regional, and national burden of neurological disorders, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2019 May;18(5):459-480. doi: 10.1016/S1474-4422(18)30499-X. Epub 2019 Mar 14.</citation>
      <PMID>30879893</PMID>
    </reference>
    <reference>
      <citation>GBD 2016 Lifetime Risk of Stroke Collaborators; Feigin VL, Nguyen G, Cercy K, Johnson CO, Alam T, Parmar PG, Abajobir AA, Abate KH, Abd-Allah F, Abejie AN, Abyu GY, Ademi Z, Agarwal G, Ahmed MB, Akinyemi RO, Al-Raddadi R, Aminde LN, Amlie-Lefond C, Ansari H, Asayesh H, Asgedom SW, Atey TM, Ayele HT, Banach M, Banerjee A, Barac A, Barker-Collo SL, Barnighausen T, Barregard L, Basu S, Bedi N, Behzadifar M, Bejot Y, Bennett DA, Bensenor IM, Berhe DF, Boneya DJ, Brainin M, Campos-Nonato IR, Caso V, Castaneda-Orjuela CA, Rivas JC, Catala-Lopez F, Christensen H, Criqui MH, Damasceno A, Dandona L, Dandona R, Davletov K, de Courten B, deVeber G, Dokova K, Edessa D, Endres M, Faraon EJA, Farvid MS, Fischer F, Foreman K, Forouzanfar MH, Gall SL, Gebrehiwot TT, Geleijnse JM, Gillum RF, Giroud M, Goulart AC, Gupta R, Gupta R, Hachinski V, Hamadeh RR, Hankey GJ, Hareri HA, Havmoeller R, Hay SI, Hegazy MI, Hibstu DT, James SL, Jeemon P, John D, Jonas JB, Jozwiak J, Kalani R, Kandel A, Kasaeian A, Kengne AP, Khader YS, Khan AR, Khang YH, Khubchandani J, Kim D, Kim YJ, Kivimaki M, Kokubo Y, Kolte D, Kopec JA, Kosen S, Kravchenko M, Krishnamurthi R, Kumar GA, Lafranconi A, Lavados PM, Legesse Y, Li Y, Liang X, Lo WD, Lorkowski S, Lotufo PA, Loy CT, Mackay MT, Abd El Razek HM, Mahdavi M, Majeed A, Malekzadeh R, Malta DC, Mamun AA, Mantovani LG, Martins SCO, Mate KK, Mazidi M, Mehata S, Meier T, Melaku YA, Mendoza W, Mensah GA, Meretoja A, Mezgebe HB, Miazgowski T, Miller TR, Ibrahim NM, Mohammed S, Mokdad AH, Moosazadeh M, Moran AE, Musa KI, Negoi RI, Nguyen M, Nguyen QL, Nguyen TH, Tran TT, Nguyen TT, Anggraini Ningrum DN, Norrving B, Noubiap JJ, O'Donnell MJ, Olagunju AT, Onuma OK, Owolabi MO, Parsaeian M, Patton GC, Piradov M, Pletcher MA, Pourmalek F, Prakash V, Qorbani M, Rahman M, Rahman MA, Rai RK, Ranta A, Rawaf D, Rawaf S, Renzaho AM, Robinson SR, Sahathevan R, Sahebkar A, Salomon JA, Santalucia P, Santos IS, Sartorius B, Schutte AE, Sepanlou SG, Shafieesabet A, Shaikh MA, Shamsizadeh M, Sheth KN, Sisay M, Shin MJ, Shiue I, Silva DAS, Sobngwi E, Soljak M, Sorensen RJD, Sposato LA, Stranges S, Suliankatchi RA, Tabares-Seisdedos R, Tanne D, Nguyen CT, Thakur JS, Thrift AG, Tirschwell DL, Topor-Madry R, Tran BX, Nguyen LT, Truelsen T, Tsilimparis N, Tyrovolas S, Ukwaja KN, Uthman OA, Varakin Y, Vasankari T, Venketasubramanian N, Vlassov VV, Wang W, Werdecker A, Wolfe CDA, Xu G, Yano Y, Yonemoto N, Yu C, Zaidi Z, El Sayed Zaki M, Zhou M, Ziaeian B, Zipkin B, Vos T, Naghavi M, Murray CJL, Roth GA. Global, Regional, and Country-Specific Lifetime Risks of Stroke, 1990 and 2016. N Engl J Med. 2018 Dec 20;379(25):2429-2437. doi: 10.1056/NEJMoa1804492.</citation>
      <PMID>30575491</PMID>
    </reference>
    <reference>
      <citation>Secondary prevention in non-rheumatic atrial fibrillation after transient ischaemic attack or minor stroke. EAFT (European Atrial Fibrillation Trial) Study Group. Lancet. 1993 Nov 20;342(8882):1255-62.</citation>
      <PMID>7901582</PMID>
    </reference>
    <reference>
      <citation>Hart RG, Pearce LA, Koudstaal PJ. Transient ischemic attacks in patients with atrial fibrillation: implications for secondary prevention: the European Atrial Fibrillation Trial and Stroke Prevention in Atrial Fibrillation III trial. Stroke. 2004 Apr;35(4):948-51. doi: 10.1161/01.STR.0000120741.34866.1D. Epub 2004 Feb 26.</citation>
      <PMID>14988571</PMID>
    </reference>
    <reference>
      <citation>Hart RG, Diener HC, Coutts SB, Easton JD, Granger CB, O'Donnell MJ, Sacco RL, Connolly SJ; Cryptogenic Stroke/ESUS International Working Group. Embolic strokes of undetermined source: the case for a new clinical construct. Lancet Neurol. 2014 Apr;13(4):429-38. doi: 10.1016/S1474-4422(13)70310-7.</citation>
      <PMID>24646875</PMID>
    </reference>
    <reference>
      <citation>Sanna T, Diener HC, Passman RS, Di Lazzaro V, Bernstein RA, Morillo CA, Rymer MM, Thijs V, Rogers T, Beckers F, Lindborg K, Brachmann J; CRYSTAL AF Investigators. Cryptogenic stroke and underlying atrial fibrillation. N Engl J Med. 2014 Jun 26;370(26):2478-86. doi: 10.1056/NEJMoa1313600.</citation>
      <PMID>24963567</PMID>
    </reference>
    <reference>
      <citation>Gladstone DJ, Spring M, Dorian P, Panzov V, Thorpe KE, Hall J, Vaid H, O'Donnell M, Laupacis A, Cote R, Sharma M, Blakely JA, Shuaib A, Hachinski V, Coutts SB, Sahlas DJ, Teal P, Yip S, Spence JD, Buck B, Verreault S, Casaubon LK, Penn A, Selchen D, Jin A, Howse D, Mehdiratta M, Boyle K, Aviv R, Kapral MK, Mamdani M; EMBRACE Investigators and Coordinators. Atrial fibrillation in patients with cryptogenic stroke. N Engl J Med. 2014 Jun 26;370(26):2467-77. doi: 10.1056/NEJMoa1311376.</citation>
      <PMID>24963566</PMID>
    </reference>
    <reference>
      <citation>Tsivgoulis G, Katsanos AH, Grory BM, Kohrmann M, Ricci BA, Tsioufis K, Cutting S, Krogias C, Schellinger PD, Campello AR, Cuadrado-Godia E, Gladstone DJ, Sanna T, Wachter R, Furie K, Alexandrov AV, Yaghi S. Prolonged Cardiac Rhythm Monitoring and Secondary Stroke Prevention in Patients With Cryptogenic Cerebral Ischemia. Stroke. 2019 Aug;50(8):2175-2180. doi: 10.1161/STROKEAHA.119.025169. Epub 2019 Jun 20.</citation>
      <PMID>31216964</PMID>
    </reference>
    <reference>
      <citation>Perez MV, Mahaffey KW, Hedlin H, Rumsfeld JS, Garcia A, Ferris T, Balasubramanian V, Russo AM, Rajmane A, Cheung L, Hung G, Lee J, Kowey P, Talati N, Nag D, Gummidipundi SE, Beatty A, Hills MT, Desai S, Granger CB, Desai M, Turakhia MP; Apple Heart Study Investigators. Large-Scale Assessment of a Smartwatch to Identify Atrial Fibrillation. N Engl J Med. 2019 Nov 14;381(20):1909-1917. doi: 10.1056/NEJMoa1901183.</citation>
      <PMID>31722151</PMID>
    </reference>
    <reference>
      <citation>Tison GH, Sanchez JM, Ballinger B, Singh A, Olgin JE, Pletcher MJ, Vittinghoff E, Lee ES, Fan SM, Gladstone RA, Mikell C, Sohoni N, Hsieh J, Marcus GM. Passive Detection of Atrial Fibrillation Using a Commercially Available Smartwatch. JAMA Cardiol. 2018 May 1;3(5):409-416. doi: 10.1001/jamacardio.2018.0136.</citation>
      <PMID>29562087</PMID>
    </reference>
    <reference>
      <citation>Dorr M, Nohturfft V, Brasier N, Bosshard E, Djurdjevic A, Gross S, Raichle CJ, Rhinisperger M, Stockli R, Eckstein J. The WATCH AF Trial: SmartWATCHes for Detection of Atrial Fibrillation. JACC Clin Electrophysiol. 2019 Feb;5(2):199-208. doi: 10.1016/j.jacep.2018.10.006. Epub 2018 Nov 28.</citation>
      <PMID>30784691</PMID>
    </reference>
    <reference>
      <citation>Wasserlauf J, You C, Patel R, Valys A, Albert D, Passman R. Smartwatch Performance for the Detection and Quantification of Atrial Fibrillation. Circ Arrhythm Electrophysiol. 2019 Jun;12(6):e006834. doi: 10.1161/CIRCEP.118.006834.</citation>
      <PMID>31113234</PMID>
    </reference>
    <reference>
      <citation>Afzal MR, Gunda S, Waheed S, Sehar N, Maybrook RJ, Dawn B, Lakkireddy D. Role of Outpatient Cardiac Rhythm Monitoring in Cryptogenic Stroke: A Systematic Review and Meta-Analysis. Pacing Clin Electrophysiol. 2015 Oct;38(10):1236-45. doi: 10.1111/pace.12688. Epub 2015 Aug 27.</citation>
      <PMID>26172621</PMID>
    </reference>
    <reference>
      <citation>Ding EY, CastanedaAvila M, Tran KV, Mehawej J, Filippaios A, Paul T, Otabil EM, Noorishirazi K, Han D, Saczynski JS, Barton B, Mazor KM, Chon K, McManus DD. Usability of a smartwatch for atrial fibrillation detection in older adults after stroke. Cardiovasc Digit Health J. 2022 Apr 18;3(3):126-135. doi: 10.1016/j.cvdhj.2022.03.003. eCollection 2022 Jun.</citation>
      <PMID>35720675</PMID>
    </reference>
    <reference>
      <citation>Poli S, Diedler J, Hartig F, Gotz N, Bauer A, Sachse T, Muller K, Muller I, Stimpfle F, Duckheim M, Steeg M, Eick C, Schreieck J, Gawaz M, Ziemann U, Zuern CS. Insertable cardiac monitors after cryptogenic stroke--a risk factor based approach to enhance the detection rate for paroxysmal atrial fibrillation. Eur J Neurol. 2016 Feb;23(2):375-81. doi: 10.1111/ene.12843. Epub 2015 Oct 16.</citation>
      <PMID>26470854</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>August 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Smartwatch</keyword>
    <keyword>Ischemic stroke</keyword>
    <keyword>atrial fibrillation</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Stroke</mesh_term>
      <mesh_term>Ischemic Stroke</mesh_term>
      <mesh_term>Ischemic Attack, Transient</mesh_term>
      <mesh_term>Atrial Fibrillation</mesh_term>
      <mesh_term>Ischemia</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06005233
  org study id: 20230726
  nct id: NCT06005233
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Scientific Background: In secondary prevention of ischemic stroke, detection of atrial
        fibrillation (AFib) and subsequent anticoagulation therapy reduce the risk of recurrent
        stroke by approximately 60%. Prolonged electrocardiogram (ECG) monitoring up to 6 months
        significantly increases detection of AFib in cryptogenic stroke. Wearables like smartwatches
        have recently been shown to adequately detect AFib in the general population. Thus, prolonged
        ECG monitoring after cryptogenic ischemic stroke or transient ischemic attack (TIA) using a
        smartwatch could lead to a reduction of recurrent stroke by prompting adequate
        anticoagulation therapy and may constitute a cost-effective, non-invasive, and
        broadly-available alternative to the current standard of care.
  
        Hypothesis: The investigators hypothesize that AFib detection via smartwatch in patients with
        cryptogenic TIA or ischemic stroke is accurate compared to an implantable event recorder.
  
        Methods: The investigators introduce a prospective, intraindividual-controlled, multicentre
        clinical study in patients with cryptogenic ischemic stroke or TIA. In addition to an
        implanted event recorder as indicated by clinical standard, included patients receive a
        smartwatch for detection of AFib. ECG-data from smartwatches will be continuously monitored
        by two independent cardiologists. As soon as AFib is confirmed, a doctoral appointment is set
        to evaluate start of anticoagulation. The follow-up period will be six months. The study
        consists of four study visits: a baseline visit, two phone visits at one and three months,
        and an end of trial visit at six months.
  
        Primary Objective: To compare smartwatch and event recorder based analysis for sensitivity
        and specificity of AFib detection per patient after six months
  Ischemic stroke is worldwide the second most frequent cause of death and disability and has a
        lifetime risk of approximately 25%. In the secondary prevention of ischemic stroke, detection
        of atrial fibrillation (AFib) and subsequent anticoagulation therapy reduce the risk of
        recurrent stroke by approximately 60%. Cryptogenic stroke is defined as ischemic stroke for
        which no probable cause is found despite a full standard evaluation and comprises 25% of all
        ischemic strokes. Prolonged electrocardiogram (ECG) monitoring for 30 days to 6 months
        significantly increases the detection of occult paroxysmal AFib in cryptogenic stroke, which
        is present in 9 - 16%. Thus, prolonged ECG monitoring is likely to lead to a reduction of
        recurrent stroke by prompting adequate anticoagulation therapy.
  
        Still, prolonged AFib screening after stroke is currently suboptimal due to a limitation of
        resources, loss to follow-up, invasiveness of procedures, and costs. Wearables like
        smartwatches have recently been shown to adequately detect AFib in the general population.
        Sensitivity and specificity of AFib detection compared to ECG-based diagnosis is high (93-98%
        and 90-98%, respectively). Compared to implantable Event Recorders, smartwatch based AFib
        diagnosis in the general population exhibits a sensitivity of 97.5% for AFib episodes >1h and
        a sensitivity of 100% for AFib detection per patient.
  
        The investigators hypothesize that AFib detection via smartwatch in patients suffering from
        cryptogenic transient ischemic attack (TIA) or ischemic stroke is accurate for AFib detection
        compared to an implantable Event Recorder and might therefore be a non-invasive,
        cost-effective, widely available alternative, which could potentially change the current
        standard of post-stroke care.
  
        The primary objective is to assess whether AFib detection via smartwatch in patients
        suffering from cryptogenic TIA/ ischemic stroke is accurate in comparison to implantable
        Event Recorders. This will be assessed by sensitivity and specificity of AFib detection per
        patient after six months. The investigators aim on a comparison of smartwatch based,
        continuous, automated, cardiologist supervised rhythm analysis of photoplethysmography (PPG)-
        signal and patient activated 1-lead ECG with Event Recorder based, continuous, automated ECG
        rhythm analysis.
  
        This is a prospective, intraindividual-controlled, multicenter clinical study.
  
        The study population includes patients with cryptogenic TIA or ischemic stroke and known risk
        factors for the presence of paroxysmal AFib (see inclusion criteria; CHA2DS2VASc score ≥4,
        Atrial runs, Left atrial size > 45mm, Left atrial appendage flow ≤ 0.2m/s).
  
        In addition to an implanted Event Recorder according to clinical standard, patients receive a
        smartwatch. Smartwatch- and Event Recorder-derived heart rhythm are daily uploaded and
        ana-lyzed by the cardiologists at the Cardiology Core Lab at the Department of Internal
        Medicine I, Klinikum rechts der Isar, Munich. The obtained data on cardiac arrhythmia will be
        assessable for each study site in consultation with the Cardiology Core Lab. In case of an
        arrhythmic event, the obtained data on duration, source of information (e.g., smartwatch PPG
        signal, smartwatch 1-lead ECG, Event Recorder) will be implemented in the eCRF by the
        Cardiology Core Lab.
  
        In parallel, the study consists of a total of four visits. The baseline visit (Visit 0) may
        take place within the clinical setting of the acute stroke work up. A table containing a
        detailed plan of the data to be collected will be provided. Furtherly, the implementation and
        set-up of the smart-watch will take place within the baseline visit. A manual will be
        provided for each study center and patient to correctly set up and instruct on the usage of
        the smartwatch. The second and third visit (Visit 1, Visit 2) constitute phone-visits at one
        and three months with a tolerated time deviation of one week. The last visit at the end of
        the study (Visit 3) will be performed at six months with a tolerated time deviation of three
        weeks. This visit will take place at each pa-tient's study center. A table containing a
        detailed plan of the data to be collected will be pro-vided for each study center.
  
        The first patient is planned to be included approximately in the third quarter of 2023 and
        the last patient approximately in the first quarter of 2025. Accordingly, the last patient
        will exit the study ('last patient last visit') approximately by the end of 2025.
  
        The clinical study will be carried out in accordance with the study protocol and the
        principles of the Declaration of Helsinki by the World Medical Association and specific
        applicable national ethical and regulatory requirements.
  
        All patients included in the clinical study will receive standard of care for cryptogenic
        TIA/ is-chemic stroke. The clinical study protocol does not interfere with generally accepted
        standards in post stroke care and local SOPs .The applied smartwatch is CE-certified as a
        medical device for AFib detection. As the study intervention consists in simply wearing a
        smartwatch (and phone visits are implemented at one and three months), we expect no safety
        risk for study partici-pants.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: Prospective, intraindividual-controlled, multicenter clinical study.
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: Sensitivity and Specificity of AFib Detection
  time frame: From baseline visit (V0) to the last follow-up at visit (V3) at six months
  description: To estimate and compare sensitivity and specificity for AFib detection per patient after six months (Comparison of smartwatch based, continuous, automated, cardiologist supervised rhythm analysis of photoplethysmography (PPG)- signal and patient activated 1-lead ECG with Event Recorder based, continuous, automated ECG rhythm analysis).
  measure: To estimate and compare the positive and negative predictive values for AFib detection per patient
  time frame: From baseline visit (V0) to the last follow-up at visit (V3) at six months
  measure: Sensitivity and specificity for AFib detection of the automated PPG-signal rhythm analysis
  time frame: From baseline visit (V0) to the last follow-up at visit (V3) at six months
  measure: Sensitivity and specificity for the detection of any AFib episode
  time frame: From baseline visit (V0) to the last follow-up at visit (V3) at six months
  measure: Sensitivity for the detection of AFib episodes >1 hour
  time frame: From baseline visit (V0) to the last follow-up at visit (V3) at six months
  measure: Sensitivity and specificity of AFib detection per recorded/ per analyzable time (i.e., intervals in which the watch is actually worn/records an analyzable signal; per-protocol analysis)
  time frame: From baseline visit (V0) to the last follow-up at visit (V3) at six months
  measure: Specificity for episodes of sinus rhythms >1 hour
  time frame: From baseline visit (V0) to the last follow-up at visit (V3) at six months
  measure: Stroke and TIA recurrence within six months
  time frame: From baseline visit (V0) to the last follow-up at visit (V3) at six months
  description: Stroke or TIA recurrence in the clinical follop-up visits at 1, 3 and 6 months
  measure: Subgroup analysis: accuracy in severely affected patients (i.e., National Institute of Health Stroke Scale (NIHSS) ≥8)
  time frame: From baseline visit (V0) to the last follow-up at visit (V3) at six months
  description: NIHSS: 0-42 points, a higher score refers to the presence of more stroke related symtpoms/ worse outcome
  measure: Exploratory endpoint: Acceptance and practicability of smartwatches for AFib detection
  time frame: From baseline visit (V0) to the last follow-up at visit (V3) at six months
  description: self-designed questionnaire
  measure: Exploratory endpoint: AFib burden/ patient
  time frame: From baseline visit (V0) to the last follow-up at visit (V3) at six months
  description: Duration of AFib episodes/ Duration of Sinus rhythm
  measure: Exploratory endpoint: relevance of AFib risk factors
  time frame: From baseline visit (V0) to the last follow-up at visit (V3) at six months
  measure: Exploratory endpoint: AFib detection rates after one month and after six months and time to confirmed AFib diagnosis
  time frame: From baseline visit (V0) to the last follow-up at visit (V3) at six months
  measure: Exploratory endpoint: count of AFib diagnoses
  time frame: From baseline visit (V0) to the last follow-up at visit (V3) at six months
  arm group label: Application of Smartwatch
  arm group type: Experimental
  description: Application of smartwatch in addition to an implanted event recorder. Follow-up of 6 months
  intervention type: Device
  intervention name: Smartwatch
  description: Smartwatch with PPG- and 1-lead ECG derived analysis of cardiac arrhythmia. Analysis will be performed centrally at the Cardiology Core Lab at the Klinikum Rechts der Isar.
  arm group label: Application of Smartwatch
  criteria: 
  gender: All
  minimum age: 40 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Silke Wunderlich, Dr.med
  phone: 0049(0)8941404606
  email: Silke.Wunderlich@tum.de
  last name: Horst Penkert, Dr. med.
  phone: 0049(0)8941404606
  email: h.penkert@tum.de
  facility: 
  contact: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  country: Germany
  citation: GBD 2016 Neurology Collaborators. Global, regional, and national burden of neurological disorders, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2019 May;18(5):459-480. doi: 10.1016/S1474-4422(18)30499-X. Epub 2019 Mar 14.
  PMID: 30879893
  citation: GBD 2016 Lifetime Risk of Stroke Collaborators; Feigin VL, Nguyen G, Cercy K, Johnson CO, Alam T, Parmar PG, Abajobir AA, Abate KH, Abd-Allah F, Abejie AN, Abyu GY, Ademi Z, Agarwal G, Ahmed MB, Akinyemi RO, Al-Raddadi R, Aminde LN, Amlie-Lefond C, Ansari H, Asayesh H, Asgedom SW, Atey TM, Ayele HT, Banach M, Banerjee A, Barac A, Barker-Collo SL, Barnighausen T, Barregard L, Basu S, Bedi N, Behzadifar M, Bejot Y, Bennett DA, Bensenor IM, Berhe DF, Boneya DJ, Brainin M, Campos-Nonato IR, Caso V, Castaneda-Orjuela CA, Rivas JC, Catala-Lopez F, Christensen H, Criqui MH, Damasceno A, Dandona L, Dandona R, Davletov K, de Courten B, deVeber G, Dokova K, Edessa D, Endres M, Faraon EJA, Farvid MS, Fischer F, Foreman K, Forouzanfar MH, Gall SL, Gebrehiwot TT, Geleijnse JM, Gillum RF, Giroud M, Goulart AC, Gupta R, Gupta R, Hachinski V, Hamadeh RR, Hankey GJ, Hareri HA, Havmoeller R, Hay SI, Hegazy MI, Hibstu DT, James SL, Jeemon P, John D, Jonas JB, Jozwiak J, Kalani R, Kandel A, Kasaeian A, Kengne AP, Khader YS, Khan AR, Khang YH, Khubchandani J, Kim D, Kim YJ, Kivimaki M, Kokubo Y, Kolte D, Kopec JA, Kosen S, Kravchenko M, Krishnamurthi R, Kumar GA, Lafranconi A, Lavados PM, Legesse Y, Li Y, Liang X, Lo WD, Lorkowski S, Lotufo PA, Loy CT, Mackay MT, Abd El Razek HM, Mahdavi M, Majeed A, Malekzadeh R, Malta DC, Mamun AA, Mantovani LG, Martins SCO, Mate KK, Mazidi M, Mehata S, Meier T, Melaku YA, Mendoza W, Mensah GA, Meretoja A, Mezgebe HB, Miazgowski T, Miller TR, Ibrahim NM, Mohammed S, Mokdad AH, Moosazadeh M, Moran AE, Musa KI, Negoi RI, Nguyen M, Nguyen QL, Nguyen TH, Tran TT, Nguyen TT, Anggraini Ningrum DN, Norrving B, Noubiap JJ, O'Donnell MJ, Olagunju AT, Onuma OK, Owolabi MO, Parsaeian M, Patton GC, Piradov M, Pletcher MA, Pourmalek F, Prakash V, Qorbani M, Rahman M, Rahman MA, Rai RK, Ranta A, Rawaf D, Rawaf S, Renzaho AM, Robinson SR, Sahathevan R, Sahebkar A, Salomon JA, Santalucia P, Santos IS, Sartorius B, Schutte AE, Sepanlou SG, Shafieesabet A, Shaikh MA, Shamsizadeh M, Sheth KN, Sisay M, Shin MJ, Shiue I, Silva DAS, Sobngwi E, Soljak M, Sorensen RJD, Sposato LA, Stranges S, Suliankatchi RA, Tabares-Seisdedos R, Tanne D, Nguyen CT, Thakur JS, Thrift AG, Tirschwell DL, Topor-Madry R, Tran BX, Nguyen LT, Truelsen T, Tsilimparis N, Tyrovolas S, Ukwaja KN, Uthman OA, Varakin Y, Vasankari T, Venketasubramanian N, Vlassov VV, Wang W, Werdecker A, Wolfe CDA, Xu G, Yano Y, Yonemoto N, Yu C, Zaidi Z, El Sayed Zaki M, Zhou M, Ziaeian B, Zipkin B, Vos T, Naghavi M, Murray CJL, Roth GA. Global, Regional, and Country-Specific Lifetime Risks of Stroke, 1990 and 2016. N Engl J Med. 2018 Dec 20;379(25):2429-2437. doi: 10.1056/NEJMoa1804492.
  PMID: 30575491
  citation: Secondary prevention in non-rheumatic atrial fibrillation after transient ischaemic attack or minor stroke. EAFT (European Atrial Fibrillation Trial) Study Group. Lancet. 1993 Nov 20;342(8882):1255-62.
  PMID: 7901582
  citation: Hart RG, Pearce LA, Koudstaal PJ. Transient ischemic attacks in patients with atrial fibrillation: implications for secondary prevention: the European Atrial Fibrillation Trial and Stroke Prevention in Atrial Fibrillation III trial. Stroke. 2004 Apr;35(4):948-51. doi: 10.1161/01.STR.0000120741.34866.1D. Epub 2004 Feb 26.
  PMID: 14988571
  citation: Hart RG, Diener HC, Coutts SB, Easton JD, Granger CB, O'Donnell MJ, Sacco RL, Connolly SJ; Cryptogenic Stroke/ESUS International Working Group. Embolic strokes of undetermined source: the case for a new clinical construct. Lancet Neurol. 2014 Apr;13(4):429-38. doi: 10.1016/S1474-4422(13)70310-7.
  PMID: 24646875
  citation: Sanna T, Diener HC, Passman RS, Di Lazzaro V, Bernstein RA, Morillo CA, Rymer MM, Thijs V, Rogers T, Beckers F, Lindborg K, Brachmann J; CRYSTAL AF Investigators. Cryptogenic stroke and underlying atrial fibrillation. N Engl J Med. 2014 Jun 26;370(26):2478-86. doi: 10.1056/NEJMoa1313600.
  PMID: 24963567
  citation: Gladstone DJ, Spring M, Dorian P, Panzov V, Thorpe KE, Hall J, Vaid H, O'Donnell M, Laupacis A, Cote R, Sharma M, Blakely JA, Shuaib A, Hachinski V, Coutts SB, Sahlas DJ, Teal P, Yip S, Spence JD, Buck B, Verreault S, Casaubon LK, Penn A, Selchen D, Jin A, Howse D, Mehdiratta M, Boyle K, Aviv R, Kapral MK, Mamdani M; EMBRACE Investigators and Coordinators. Atrial fibrillation in patients with cryptogenic stroke. N Engl J Med. 2014 Jun 26;370(26):2467-77. doi: 10.1056/NEJMoa1311376.
  PMID: 24963566
  citation: Tsivgoulis G, Katsanos AH, Grory BM, Kohrmann M, Ricci BA, Tsioufis K, Cutting S, Krogias C, Schellinger PD, Campello AR, Cuadrado-Godia E, Gladstone DJ, Sanna T, Wachter R, Furie K, Alexandrov AV, Yaghi S. Prolonged Cardiac Rhythm Monitoring and Secondary Stroke Prevention in Patients With Cryptogenic Cerebral Ischemia. Stroke. 2019 Aug;50(8):2175-2180. doi: 10.1161/STROKEAHA.119.025169. Epub 2019 Jun 20.
  PMID: 31216964
  citation: Perez MV, Mahaffey KW, Hedlin H, Rumsfeld JS, Garcia A, Ferris T, Balasubramanian V, Russo AM, Rajmane A, Cheung L, Hung G, Lee J, Kowey P, Talati N, Nag D, Gummidipundi SE, Beatty A, Hills MT, Desai S, Granger CB, Desai M, Turakhia MP; Apple Heart Study Investigators. Large-Scale Assessment of a Smartwatch to Identify Atrial Fibrillation. N Engl J Med. 2019 Nov 14;381(20):1909-1917. doi: 10.1056/NEJMoa1901183.
  PMID: 31722151
  citation: Tison GH, Sanchez JM, Ballinger B, Singh A, Olgin JE, Pletcher MJ, Vittinghoff E, Lee ES, Fan SM, Gladstone RA, Mikell C, Sohoni N, Hsieh J, Marcus GM. Passive Detection of Atrial Fibrillation Using a Commercially Available Smartwatch. JAMA Cardiol. 2018 May 1;3(5):409-416. doi: 10.1001/jamacardio.2018.0136.
  PMID: 29562087
  citation: Dorr M, Nohturfft V, Brasier N, Bosshard E, Djurdjevic A, Gross S, Raichle CJ, Rhinisperger M, Stockli R, Eckstein J. The WATCH AF Trial: SmartWATCHes for Detection of Atrial Fibrillation. JACC Clin Electrophysiol. 2019 Feb;5(2):199-208. doi: 10.1016/j.jacep.2018.10.006. Epub 2018 Nov 28.
  PMID: 30784691
  citation: Wasserlauf J, You C, Patel R, Valys A, Albert D, Passman R. Smartwatch Performance for the Detection and Quantification of Atrial Fibrillation. Circ Arrhythm Electrophysiol. 2019 Jun;12(6):e006834. doi: 10.1161/CIRCEP.118.006834.
  PMID: 31113234
  citation: Afzal MR, Gunda S, Waheed S, Sehar N, Maybrook RJ, Dawn B, Lakkireddy D. Role of Outpatient Cardiac Rhythm Monitoring in Cryptogenic Stroke: A Systematic Review and Meta-Analysis. Pacing Clin Electrophysiol. 2015 Oct;38(10):1236-45. doi: 10.1111/pace.12688. Epub 2015 Aug 27.
  PMID: 26172621
  citation: Ding EY, CastanedaAvila M, Tran KV, Mehawej J, Filippaios A, Paul T, Otabil EM, Noorishirazi K, Han D, Saczynski JS, Barton B, Mazor KM, Chon K, McManus DD. Usability of a smartwatch for atrial fibrillation detection in older adults after stroke. Cardiovasc Digit Health J. 2022 Apr 18;3(3):126-135. doi: 10.1016/j.cvdhj.2022.03.003. eCollection 2022 Jun.
  PMID: 35720675
  citation: Poli S, Diedler J, Hartig F, Gotz N, Bauer A, Sachse T, Muller K, Muller I, Stimpfle F, Duckheim M, Steeg M, Eick C, Schreieck J, Gawaz M, Ziemann U, Zuern CS. Insertable cardiac monitors after cryptogenic stroke--a risk factor based approach to enhance the detection rate for paroxysmal atrial fibrillation. Eur J Neurol. 2016 Feb;23(2):375-81. doi: 10.1111/ene.12843. Epub 2015 Oct 16.
  PMID: 26470854
  responsible party type: Sponsor
  mesh term: Stroke
  mesh term: Ischemic Stroke
  mesh term: Ischemic Attack, Transient
  mesh term: Atrial Fibrillation
  mesh term: Ischemia