<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/NCT04404465</url>
  </required_header>
  <id_info>
    <org_study_id>BEAT-AFib</org_study_id>
    <nct_id>NCT04404465</nct_id>
  </id_info>
  <brief_title>Health eHeart BEAT-AFib - Health eHeart Biomarkers of Early Atrial Transformation in Atrial Fibrillation</brief_title>
  <acronym>BEAT-AFib</acronym>
  <official_title>Health eHeart BEAT-AFib - Health eHeart Biomarkers of Early Atrial Transformation in Atrial Fibrillation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, San Francisco</source>
  <oversight_info>
    <has_dmc>No</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>
      Atrial fibrillation (also known as AFib or AF) is the most common abnormal heart rhythm and&#xD;
      results in an irregular beating of the heart. Currently, there is no way of identifying&#xD;
      patients at most risk for the development or progression of AFib or those that will best&#xD;
      respond to treatment. The purpose of this study is to improve our understanding of AFib and&#xD;
      to find new ways of identifying those patients most at risk for developing AFib, have&#xD;
      progressive AFib or be less responsive to treatment. For this reason, the investigators are&#xD;
      studying imaging, blood, and digital markers that may contribute to AFib&#xD;
&#xD;
      Subjects will receive mobile devices (uch as an AliveCor Kardia and a VivaLnk Wearable ECG&#xD;
      patch or similar devices) for remote electrocardiographic (ECG) monitoring. Additionally,&#xD;
      subjects will use features using a smartphone research app (on the Eureka Research Platform)&#xD;
      to monitor other important things such as activity, sleep, heart rate and others as they are&#xD;
      developed. All subjects will receive serial blood draws and saliva sample collections once a&#xD;
      year. Subjects will also undergo annual imaging in the form of an echocardiogram (Echo).&#xD;
      Evaluations will be taken at baseline and once a year for three years from the baseline&#xD;
      visit. Additionally, electronic surveys will be administered periodically (eVisits occurring&#xD;
      every 3-6 months) using the mobile app.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a single center, longitudinal, observational cohort study. 3000 subjects are planned&#xD;
      to be enrolled. Each subject will be consented, enrolled and assigned to a group based on AF&#xD;
      diagnosis (AF Group, AF Risk Group and Control Group). All subjects will be given mobile&#xD;
      devices (such as an AliveCor Kardia and a VivaLnk Wearable ECG patch or similar devices) for&#xD;
      remote ECG monitoring. Additionally, sleep and activity can be monitored through a smartphone&#xD;
      app (on the Eureka Research Platform). All subjects will receive serial blood draws and&#xD;
      saliva sample collections to collect serum, plasma, whole blood, DNA and RNA in order to&#xD;
      observe/identify any changes in blood-borne AF markers. Subjects will also undergo serial&#xD;
      imaging in the form of an Echo to observe/identify markers and/or changes in cardiovascular&#xD;
      structure and functioning. Evaluations will be taken at baseline and once a year for three&#xD;
      years from their baseline visit. Additionally, electronic surveys will be administered&#xD;
      periodically (eVisits occurring every 3-6 months) using the mobile app to observe any changes&#xD;
      in participant reported symptoms.&#xD;
&#xD;
      Any participant who receives an AF ablation as part of clinical care will additionally&#xD;
      receive one in-person follow-up three months post-ablation procedure and an electronic survey&#xD;
      one month post-ablation procedure to observe changes in symptoms after ablation.&#xD;
&#xD;
      Subjects will be followed for at least 3 years. The total duration of the study is expected&#xD;
      to be at least 10 years. It is expected that it will take 3-4 years for subject recruitment&#xD;
      and at least 3 years for subject follow-up (3 yearly in-person visits), but anticipate the&#xD;
      digital follow-up to go beyond that (at least 10 years of digital follow-up)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">September 15, 2020</start_date>
  <completion_date type="Anticipated">September 15, 2040</completion_date>
  <primary_completion_date type="Anticipated">September 15, 2030</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Incident AF [At Risk Group]</measure>
    <time_frame>10 years</time_frame>
    <description>Incident AF is defined as the development of a new onset AF in subjects who do not have a previous AF diagnosis. This will be evaluated by detection of arrhythmias by use of ambulatory ECG monitoring (using an VivaLnk Wearable ECG patch and an AliveCor Kardia) and will be diagnosed by an automated algorithm that detects irregularly irregular rhythms. A random 50% of events will be overread by a cardiologist.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Progression of AF [AF Group]</measure>
    <time_frame>10 years</time_frame>
    <description>Progression of AF is defined as increase in AF burden which is the amount of time spent in AF over the course of one month as determined by use of ambulatory ECG monitoring (using an VivaLnk Wearable ECG patch and an AliveCor Kardia) and will be diagnosed by an automated algorithm that detects irregularly irregular rhythms. A random 50% of events will be overread by a cardiologist.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Recurrence of AF after treatment with direct current cardioversion (DCCV) or AF ablation [AF Group]</measure>
    <time_frame>10 years</time_frame>
    <description>Recurrence of AF will be evaluated by use of ambulatory ECG monitoring (using an VivaLnk Wearable ECG patch and an AliveCor Kardia) and will be diagnosed by an automated algorithm that detects irregularly irregular rhythms. A random 50% of events will be overread by a cardiologist.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptom Burden [AF Group]</measure>
    <time_frame>10 years</time_frame>
    <description>Symptom Burden will be scored by use of the University of Toronto Atrial Fibrillation Symptom Severity Scale (AFSS) which includes seven questions for subjects to report severity of symptoms (i.e. palpitations, chest pain/discomfort, shortness of breath at rest/physical activity, exercise intolerance, fatigue at rest, and lightheadedness/dizziness) on a Likert scale from 0 (subject did not have this symptom) to 5 (symptom bothers subject a great deal). Total Symptom Burden score is a sum of these seven questions and can range from 0 to 35 with a higher score indicating greater burden.</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">3000</enrollment>
  <condition>Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <description>Participants undergoing electrophysiologic (EP) study or ablation for supraventricular tachycardia (SVT) with no history of AF and does not meet criteria of At Risk Group or AF Group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>At Risk Group</arm_group_label>
    <description>Participants with no prior diagnosis of AF and have:&#xD;
two or more of the following criteria:&#xD;
Age &gt;65 years of age&#xD;
A diagnosis of hypertension&#xD;
A diagnosis of diabetes&#xD;
A diagnosis of sleep apnea&#xD;
A body mass index (BMI) ≥30&#xD;
Stable heart failure (HF) with preserved or reduced ejection fraction (New York Heart Association Class I, II or III)&#xD;
Chronic kidney disease (CKD) not requiring dialysis&#xD;
AND/ OR&#xD;
More than 5% premature atrial complex (PAC) burden on ambulatory ECG monitoring (e.g. holter, ZioPatch, Lifewatch, etc.)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AF Group</arm_group_label>
    <description>Participants who have a history of non-valvular AF or Atrial Flutter (AFL) documented on ECG or ambulatory monitoring within 1 year of enrollment</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      During the in-person baseline visit and at each in-person follow-up visit all participants&#xD;
      will have up to five (5) 10 mL tubes of peripheral blood specimens (approximately 50mL)&#xD;
      collected by typical phlebotomy procedures by trained staff.&#xD;
&#xD;
      Additionally, saliva may be collected with a DNA Spit Kit during the in-person baseline visit&#xD;
      and at each in-person follow-up visit.&#xD;
&#xD;
      Participants who receive AF ablation as part of routine clinical care will additionally have&#xD;
      up to one (1) 10 mL tube of both Coronary Sinus and (1) 10 mL tube of Left Atrial blood&#xD;
      specimens collected at time of procedure for approximately a total of 20 mL between both&#xD;
      sources.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects with a diagnosis of AF (i.e. new onset AF, paroxysmal AF, persistent AF, Permanent&#xD;
        AF), those undergoing AF ablation or DCCV, those with a PAC greater or equal to 5% PAC&#xD;
        burden, those undergoing SVT ablation, subjects with high risk of AF and healthy volunteers&#xD;
        at least 18 years of age or older who have been seen at UCSF, who meet the inclusion and&#xD;
        exclusion criteria will be eligible for participation in this study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. At least 18 years of age or older&#xD;
&#xD;
          2. English speaking&#xD;
&#xD;
          3. Able to consent&#xD;
&#xD;
          4. ANY one of the following criteria:&#xD;
&#xD;
               1. A history of non-valvular AF or AFL documented on ECG or ambulatory monitoring&#xD;
                  within 1 year of enrollment&#xD;
&#xD;
               2. Two or more of the following criteria if no history of AF:&#xD;
&#xD;
                    -  Age &gt; 65 years of age&#xD;
&#xD;
                    -  A diagnosis of hypertension&#xD;
&#xD;
                    -  A diagnosis of diabetes&#xD;
&#xD;
                    -  A diagnosis of sleep apnea&#xD;
&#xD;
                    -  A BMI ≥ 30&#xD;
&#xD;
                    -  Stable HF with preserved or reduced ejection fraction (NYHA Class I, II or&#xD;
                       III)&#xD;
&#xD;
                    -  CKD not requiring dialysis&#xD;
&#xD;
               3. More than 5% PAC burden on ambulatory ECG monitoring (e.g. Holter, Ziopatch,&#xD;
                  Lifewatch, etc.)&#xD;
&#xD;
               4. Patients undergoing EP study or ablation for SVT with no history of AF and not&#xD;
                  meeting any of the above criteria (a-c).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Life expectancy &lt; 1 year&#xD;
&#xD;
          2. Reversible causes of AF (e.g., post-operative AF, cardiac surgery, pulmonary embolism,&#xD;
             untreated hyperthyroidism)&#xD;
&#xD;
          3. Pregnant at the time of enrollment&#xD;
&#xD;
          4. Unwilling/unable to perform follow-up using digital follow-up&#xD;
&#xD;
          5. CKD requiring dialysis&#xD;
&#xD;
          6. Presence of a condition or abnormality that, in the opinion of the Investigator, would&#xD;
             compromise the safety of the patient or the quality of the data&#xD;
&#xD;
          7. Patients undergoing active treatment for cancer or diagnosed with cancer requiring&#xD;
             treatment in the last 2 years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jeffrey E Olgin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Edward P Gerstenfeld, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mark J Pletcher, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Gregory Marcus, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California, San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.cdc.gov/heartdisease/atrial_fibrillation.htm</url>
    <description>Atrial Fibrillation fact sheet from the Centers for Disease Control and Prevention website.</description>
  </link>
  <reference>
    <citation>January CT, Wann LS, Calkins H, Chen LY, Cigarroa JE, Cleveland JC Jr, Ellinor PT, Ezekowitz MD, Field ME, Furie KL, Heidenreich PA, Murray KT, Shea JB, Tracy CM, Yancy CW. 2019 AHA/ACC/HRS Focused Update of the 2014 AHA/ACC/HRS Guideline for the Management of Patients With Atrial Fibrillation: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society. J Am Coll Cardiol. 2019 Jul 9;74(1):104-132. doi: 10.1016/j.jacc.2019.01.011. Epub 2019 Jan 28. No abstract available. Erratum In: J Am Coll Cardiol. 2019 Jul 30;74(4):599.</citation>
    <PMID>30703431</PMID>
  </reference>
  <reference>
    <citation>Staerk L, Wang B, Preis SR, Larson MG, Lubitz SA, Ellinor PT, McManus DD, Ko D, Weng LC, Lunetta KL, Frost L, Benjamin EJ, Trinquart L. Lifetime risk of atrial fibrillation according to optimal, borderline, or elevated levels of risk factors: cohort study based on longitudinal data from the Framingham Heart Study. BMJ. 2018 Apr 26;361:k1453. doi: 10.1136/bmj.k1453.</citation>
    <PMID>29699974</PMID>
  </reference>
  <reference>
    <citation>Sivalokanathan S, Zghaib T, Greenland GV, Vasquez N, Kudchadkar SM, Kontari E, Lu DY, Dolores-Cerna K, van der Geest RJ, Kamel IR, Olgin JE, Abraham TP, Nazarian S, Zimmerman SL, Abraham MR. Hypertrophic Cardiomyopathy Patients With Paroxysmal Atrial Fibrillation Have a High Burden of Left Atrial Fibrosis by Cardiac Magnetic Resonance Imaging. JACC Clin Electrophysiol. 2019 Mar;5(3):364-375. doi: 10.1016/j.jacep.2018.10.016. Epub 2018 Dec 26.</citation>
    <PMID>30898240</PMID>
  </reference>
  <reference>
    <citation>Rahmutula D, Zhang H, Wilson EE, Olgin JE. Absence of natriuretic peptide clearance receptor attenuates TGF-beta1-induced selective atrial fibrosis and atrial fibrillation. Cardiovasc Res. 2019 Feb 1;115(2):357-372. doi: 10.1093/cvr/cvy224.</citation>
    <PMID>30239604</PMID>
  </reference>
  <reference>
    <citation>Rahmutula D, Marcus GM, Wilson EE, Ding CH, Xiao Y, Paquet AC, Barbeau R, Barczak AJ, Erle DJ, Olgin JE. Molecular basis of selective atrial fibrosis due to overexpression of transforming growth factor-beta1. Cardiovasc Res. 2013 Sep 1;99(4):769-79. doi: 10.1093/cvr/cvt074. Epub 2013 Apr 23.</citation>
    <PMID>23612580</PMID>
  </reference>
  <reference>
    <citation>Kim AM, Olgin JE. Microfibrosis and complex fractionated atrial electrograms. Heart Rhythm. 2009 Jun;6(6):811-2. doi: 10.1016/j.hrthm.2009.03.006. Epub 2009 Mar 3. No abstract available.</citation>
    <PMID>19467509</PMID>
  </reference>
  <reference>
    <citation>Everett TH 4th, Olgin JE. Atrial fibrosis and the mechanisms of atrial fibrillation. Heart Rhythm. 2007 Mar;4(3 Suppl):S24-7. doi: 10.1016/j.hrthm.2006.12.040. Epub 2006 Dec 28.</citation>
    <PMID>17336879</PMID>
  </reference>
  <reference>
    <citation>Marcus GM, Yang Y, Varosy PD, Ordovas K, Tseng ZH, Badhwar N, Lee BK, Lee RJ, Scheinman MM, Olgin JE. Regional left atrial voltage in patients with atrial fibrillation. Heart Rhythm. 2007 Feb;4(2):138-44. doi: 10.1016/j.hrthm.2006.10.017. Epub 2006 Oct 20.</citation>
    <PMID>17275746</PMID>
  </reference>
  <reference>
    <citation>Lee KW, Everett TH 4th, Rahmutula D, Guerra JM, Wilson E, Ding C, Olgin JE. Pirfenidone prevents the development of a vulnerable substrate for atrial fibrillation in a canine model of heart failure. Circulation. 2006 Oct 17;114(16):1703-12. doi: 10.1161/CIRCULATIONAHA.106.624320. Epub 2006 Oct 9.</citation>
    <PMID>17030685</PMID>
  </reference>
  <reference>
    <citation>Verheule S, Sato T, Everett T 4th, Engle SK, Otten D, Rubart-von der Lohe M, Nakajima HO, Nakajima H, Field LJ, Olgin JE. Increased vulnerability to atrial fibrillation in transgenic mice with selective atrial fibrosis caused by overexpression of TGF-beta1. Circ Res. 2004 Jun 11;94(11):1458-65. doi: 10.1161/01.RES.0000129579.59664.9d. Epub 2004 Apr 29.</citation>
    <PMID>15117823</PMID>
  </reference>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>May 15, 2020</study_first_submitted>
  <study_first_submitted_qc>May 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>March 30, 2023</last_update_submitted>
  <last_update_submitted_qc>March 30, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04404465
org study id: BEAT-AFib
nct id: NCT04404465
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Atrial fibrillation (also known as AFib or AF) is the most common abnormal heart rhythm and
      results in an irregular beating of the heart. Currently, there is no way of identifying
      patients at most risk for the development or progression of AFib or those that will best
      respond to treatment. The purpose of this study is to improve our understanding of AFib and
      to find new ways of identifying those patients most at risk for developing AFib, have
      progressive AFib or be less responsive to treatment. For this reason, the investigators are
      studying imaging, blood, and digital markers that may contribute to AFib

      Subjects will receive mobile devices (uch as an AliveCor Kardia and a VivaLnk Wearable ECG
      patch or similar devices) for remote electrocardiographic (ECG) monitoring. Additionally,
      subjects will use features using a smartphone research app (on the Eureka Research Platform)
      to monitor other important things such as activity, sleep, heart rate and others as they are
      developed. All subjects will receive serial blood draws and saliva sample collections once a
      year. Subjects will also undergo annual imaging in the form of an echocardiogram (Echo).
      Evaluations will be taken at baseline and once a year for three years from the baseline
      visit. Additionally, electronic surveys will be administered periodically (eVisits occurring
      every 3-6 months) using the mobile app.
This is a single center, longitudinal, observational cohort study. 3000 subjects are planned
      to be enrolled. Each subject will be consented, enrolled and assigned to a group based on AF
      diagnosis (AF Group, AF Risk Group and Control Group). All subjects will be given mobile
      devices (such as an AliveCor Kardia and a VivaLnk Wearable ECG patch or similar devices) for
      remote ECG monitoring. Additionally, sleep and activity can be monitored through a smartphone
      app (on the Eureka Research Platform). All subjects will receive serial blood draws and
      saliva sample collections to collect serum, plasma, whole blood, DNA and RNA in order to
      observe/identify any changes in blood-borne AF markers. Subjects will also undergo serial
      imaging in the form of an Echo to observe/identify markers and/or changes in cardiovascular
      structure and functioning. Evaluations will be taken at baseline and once a year for three
      years from their baseline visit. Additionally, electronic surveys will be administered
      periodically (eVisits occurring every 3-6 months) using the mobile app to observe any changes
      in participant reported symptoms.

      Any participant who receives an AF ablation as part of clinical care will additionally
      receive one in-person follow-up three months post-ablation procedure and an electronic survey
      one month post-ablation procedure to observe changes in symptoms after ablation.

      Subjects will be followed for at least 3 years. The total duration of the study is expected
      to be at least 10 years. It is expected that it will take 3-4 years for subject recruitment
      and at least 3 years for subject follow-up (3 yearly in-person visits), but anticipate the
      digital follow-up to go beyond that (at least 10 years of digital follow-up)
observational model: Cohort
time perspective: Prospective
measure: Incident AF [At Risk Group]
time frame: 10 years
description: Incident AF is defined as the development of a new onset AF in subjects who do not have a previous AF diagnosis. This will be evaluated by detection of arrhythmias by use of ambulatory ECG monitoring (using an VivaLnk Wearable ECG patch and an AliveCor Kardia) and will be diagnosed by an automated algorithm that detects irregularly irregular rhythms. A random 50% of events will be overread by a cardiologist.
measure: Progression of AF [AF Group]
time frame: 10 years
description: Progression of AF is defined as increase in AF burden which is the amount of time spent in AF over the course of one month as determined by use of ambulatory ECG monitoring (using an VivaLnk Wearable ECG patch and an AliveCor Kardia) and will be diagnosed by an automated algorithm that detects irregularly irregular rhythms. A random 50% of events will be overread by a cardiologist.
measure: Recurrence of AF after treatment with direct current cardioversion (DCCV) or AF ablation [AF Group]
time frame: 10 years
description: Recurrence of AF will be evaluated by use of ambulatory ECG monitoring (using an VivaLnk Wearable ECG patch and an AliveCor Kardia) and will be diagnosed by an automated algorithm that detects irregularly irregular rhythms. A random 50% of events will be overread by a cardiologist.
measure: Symptom Burden [AF Group]
time frame: 10 years
description: Symptom Burden will be scored by use of the University of Toronto Atrial Fibrillation Symptom Severity Scale (AFSS) which includes seven questions for subjects to report severity of symptoms (i.e. palpitations, chest pain/discomfort, shortness of breath at rest/physical activity, exercise intolerance, fatigue at rest, and lightheadedness/dizziness) on a Likert scale from 0 (subject did not have this symptom) to 5 (symptom bothers subject a great deal). Total Symptom Burden score is a sum of these seven questions and can range from 0 to 35 with a higher score indicating greater burden.
arm group label: Control Group
description: Participants undergoing electrophysiologic (EP) study or ablation for supraventricular tachycardia (SVT) with no history of AF and does not meet criteria of At Risk Group or AF Group
arm group label: At Risk Group
description: Participants with no prior diagnosis of AF and have:
two or more of the following criteria:
Age >65 years of age
A diagnosis of hypertension
A diagnosis of diabetes
A diagnosis of sleep apnea
A body mass index (BMI) ≥30
Stable heart failure (HF) with preserved or reduced ejection fraction (New York Heart Association Class I, II or III)
Chronic kidney disease (CKD) not requiring dialysis
AND/ OR
More than 5% premature atrial complex (PAC) burden on ambulatory ECG monitoring (e.g. holter, ZioPatch, Lifewatch, etc.)
arm group label: AF Group
description: Participants who have a history of non-valvular AF or Atrial Flutter (AFL) documented on ECG or ambulatory monitoring within 1 year of enrollment
During the in-person baseline visit and at each in-person follow-up visit all participants
      will have up to five (5) 10 mL tubes of peripheral blood specimens (approximately 50mL)
      collected by typical phlebotomy procedures by trained staff.

      Additionally, saliva may be collected with a DNA Spit Kit during the in-person baseline visit
      and at each in-person follow-up visit.

      Participants who receive AF ablation as part of routine clinical care will additionally have
      up to one (1) 10 mL tube of both Coronary Sinus and (1) 10 mL tube of Left Atrial blood
      specimens collected at time of procedure for approximately a total of 20 mL between both
      sources.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jeffrey E Olgin, MD
role: Principal Investigator
affiliation: University of California, San Francisco
last name: Edward P Gerstenfeld, MD
role: Principal Investigator
affiliation: University of California, San Francisco
last name: Mark J Pletcher, MD
role: Principal Investigator
affiliation: University of California, San Francisco
last name: Gregory Marcus, MD
role: Principal Investigator
affiliation: University of California, San Francisco
facility: 
country: United States
url: https://www.cdc.gov/heartdisease/atrial_fibrillation.htm
description: Atrial Fibrillation fact sheet from the Centers for Disease Control and Prevention website.
citation: January CT, Wann LS, Calkins H, Chen LY, Cigarroa JE, Cleveland JC Jr, Ellinor PT, Ezekowitz MD, Field ME, Furie KL, Heidenreich PA, Murray KT, Shea JB, Tracy CM, Yancy CW. 2019 AHA/ACC/HRS Focused Update of the 2014 AHA/ACC/HRS Guideline for the Management of Patients With Atrial Fibrillation: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society. J Am Coll Cardiol. 2019 Jul 9;74(1):104-132. doi: 10.1016/j.jacc.2019.01.011. Epub 2019 Jan 28. No abstract available. Erratum In: J Am Coll Cardiol. 2019 Jul 30;74(4):599.
PMID: 30703431
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responsible party type: Sponsor
mesh term: Atrial Fibrillation
sharing ipd: No