<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/NCT03242694</url>
  </required_header>
  <id_info>
    <org_study_id>LAMPP 1.0</org_study_id>
    <nct_id>NCT03242694</nct_id>
  </id_info>
  <brief_title>Left Atrial Function Analysis for Patients With Persistent Atrial Fibrillation Undergoing Pulmonary Vein Isolation</brief_title>
  <acronym>LAMPP</acronym>
  <official_title>Left Atrial Function Analysis With Multimodal Techniques for Patients With Persistent Atrial Fibrillation Undergoing Pulmonary Vein Isolation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Semmelweis University Heart and Vascular Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Semmelweis University Heart and Vascular Center</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>
      This prospective observational study is designed to describe the factors determining the&#xD;
      success of pulmonary vein isolation (PVI) for patients with persistent atrial fibrillation&#xD;
      (AF). These factors - described as left atrial (LA) function - are simultaneously studied by&#xD;
      multi-modal techniques in patients undergoing radiofrequency ablation. The simultaneous&#xD;
      measurements are conducted before the PVI in AF and after the sinus rhythm converted due to&#xD;
      PVI. These measurements include invasive LA pressure monitoring, LA voltage map creation, LA&#xD;
      strain evaluation by transthoracal echocardiography, LA scar-mapping by cardiac MRI, defining&#xD;
      biomarkers from blood samples. During the one year follow-up period rhythm monitoring is&#xD;
      conducted by regular Holter-monitoring. Our aim is to define the predictive values of the&#xD;
      above mentioned factors and to create a new score system for predicting PVI success in&#xD;
      persistent AF population.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2019</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2019</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>one-year success of pulmonary vein isolation</measure>
    <time_frame>3-12 months after the first pulmonary vein isolation</time_frame>
    <description>one-year success without recurrent atrial fibrillation or atrial tachycardia without antiarrhythmic drugs after the three-month blanking period of pulmonary vein isolation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>acute unsuccessful pulmonary vein isolation</measure>
    <time_frame>within 5 minutes after the last application is performed at the ablation procedure</time_frame>
    <description>operator is unable to disconnect pulmonary veins from the left atrium</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>usage of antiarrhythmic drugs after the three-month blanking period</measure>
    <time_frame>3-12 months after the first pulmonary vein isolation</time_frame>
    <description>antiarrhythmic drugs: sotalol, amiodarone, propafenon</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>reablation</measure>
    <time_frame>3-12 months after the first pulmonary vein isolation</time_frame>
    <description>repeated left atrial ablation is performed due to atrial fibrillation or left atrial tachycardia recurrence</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>major complications of pulmonary vein isolation</measure>
    <time_frame>through 1 year follow-up after the first pulmonary vein isolation</time_frame>
    <description>major complications: requiring surgical intervention or causing prolonged hospitalisation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MACE</measure>
    <time_frame>through 1 year follow-up after the first pulmonary vein isolation</time_frame>
    <description>major adverse cardiac events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>death</measure>
    <time_frame>through 1 year follow-up after the first pulmonary vein isolation</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Persistent Atrial Fibrillation</condition>
  <condition>Catheter Ablation</condition>
  <arm_group>
    <arm_group_label>persistent atrial fibrillation</arm_group_label>
    <description>invasive LA pressure monitoring, LA voltage map creation, LA strain evaluation by transthoracal echocardiography, LA scar-mapping by cardiac MRI, defining biomarkers from blood samples during atrial fibrillation and after pulmonary vein isolation in sinus rhythm</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>LA pressure, voltage map, strain, scar-map, blood sampling</intervention_name>
    <description>invasive LA pressure monitoring, LA voltage map creation, LA strain evaluation by transthoracal echocardiography, LA scar-mapping by cardiac MRI, defining biomarkers from blood samples during atrial fibrillation and after pulmonary vein isolation in sinus rhythm</description>
    <arm_group_label>persistent atrial fibrillation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>pulmonary vein isolation</intervention_name>
    <description>pulmonary vein isolation without creating additional ablation lesions</description>
    <arm_group_label>persistent atrial fibrillation</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      venous blood samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with persistent atrial fibrillation referred for pulmonary vein isolation at Heart&#xD;
        and Vascular Center of Semmelweis University, Budapest, Hungary.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  documented, symptomatic persistent atrial fibrillation (AF)&#xD;
&#xD;
          -  catheter ablation is indicated&#xD;
&#xD;
          -  aged 18-75 years&#xD;
&#xD;
          -  signed Patient Informed Consent Form&#xD;
&#xD;
          -  able and willing to comply with all pre-, post-, and follow-up testing and&#xD;
             requirements&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  secondary AF&#xD;
&#xD;
          -  paroxysmal, long-standing persistent or permanent AF&#xD;
&#xD;
          -  ejection fraction &lt; 30%&#xD;
&#xD;
          -  GFR &lt;30 ml/min/1.73m2&#xD;
&#xD;
          -  unstable angina pectoris or myocardial infarction within the past 2 months&#xD;
&#xD;
          -  severe heart failure (NYHA IV)&#xD;
&#xD;
          -  severe COPD (GOLD III-IV)&#xD;
&#xD;
          -  previous left atrial catheter ablation&#xD;
&#xD;
          -  previous transthoracic cardiac surgery&#xD;
&#xD;
          -  implanted cardiac device (pacemaker, ICD, CRT, VAD)&#xD;
&#xD;
          -  awaiting cardiac transplantation or other cardiac surgery within the next 12 months&#xD;
&#xD;
          -  any contraindication for pulmonary vein isolation, MRI or anticoagulation&#xD;
&#xD;
          -  coagulopathy&#xD;
&#xD;
          -  active malignancy, left atrial myxoma&#xD;
&#xD;
          -  autoimmune disorder, chronic inflammatory disease&#xD;
&#xD;
          -  acute illness, active systemic infection, sepsis&#xD;
&#xD;
          -  women who are pregnant, breast feeding, or planning to become pregnant in the next 12&#xD;
             months&#xD;
&#xD;
          -  aged under 18 years or above 75 years&#xD;
&#xD;
          -  enrollment in other studies, which exclude participation in other studies&#xD;
&#xD;
          -  patient not willing or not able to sign the informed consent form&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Laszlo Geller, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Heart and Vascular Center of Semmelweis University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Bela Merkely, MD PhD DSc</last_name>
    <role>Study Director</role>
    <affiliation>Heart and Vascular Center of Semmelweis University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Szilvia Herczeg, MD</last_name>
    <phone>0036206663198</phone>
    <email>herczeg.szilvia@med.semmelweis-univ.hu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Nandor Szegedi, MD</last_name>
    <phone>0036206663442</phone>
    <email>szegedi.nandor@med.semmelweis-univ.hu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Heart and Vascular Center of Semmelweis University</name>
      <address>
        <city>Budapest</city>
        <zip>1122</zip>
        <country>Hungary</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Peter Perge, MD</last_name>
      <phone>0036208259612</phone>
      <email>perge.peter@med.semmelweis-univ.hu</email>
    </contact>
  </location>
  <location_countries>
    <country>Hungary</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>July 31, 2017</study_first_submitted>
  <study_first_submitted_qc>August 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 8, 2017</study_first_posted>
  <last_update_submitted>August 3, 2017</last_update_submitted>
  <last_update_submitted_qc>August 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 8, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>persistent atrial fibrillation</keyword>
  <keyword>pulmonary vein isolation</keyword>
  <keyword>catheter ablation</keyword>
  <keyword>left atrial function</keyword>
  <keyword>left atrial pressure</keyword>
  <keyword>voltage map</keyword>
  <keyword>strain</keyword>
  <keyword>scar</keyword>
  <keyword>success</keyword>
  <keyword>biomarker</keyword>
  <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/NCT03242694
org study id: LAMPP 1.0
nct id: NCT03242694
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This prospective observational study is designed to describe the factors determining the
      success of pulmonary vein isolation (PVI) for patients with persistent atrial fibrillation
      (AF). These factors - described as left atrial (LA) function - are simultaneously studied by
      multi-modal techniques in patients undergoing radiofrequency ablation. The simultaneous
      measurements are conducted before the PVI in AF and after the sinus rhythm converted due to
      PVI. These measurements include invasive LA pressure monitoring, LA voltage map creation, LA
      strain evaluation by transthoracal echocardiography, LA scar-mapping by cardiac MRI, defining
      biomarkers from blood samples. During the one year follow-up period rhythm monitoring is
      conducted by regular Holter-monitoring. Our aim is to define the predictive values of the
      above mentioned factors and to create a new score system for predicting PVI success in
      persistent AF population.
observational model: Cohort
time perspective: Prospective
measure: one-year success of pulmonary vein isolation
time frame: 3-12 months after the first pulmonary vein isolation
description: one-year success without recurrent atrial fibrillation or atrial tachycardia without antiarrhythmic drugs after the three-month blanking period of pulmonary vein isolation
measure: acute unsuccessful pulmonary vein isolation
time frame: within 5 minutes after the last application is performed at the ablation procedure
description: operator is unable to disconnect pulmonary veins from the left atrium
measure: usage of antiarrhythmic drugs after the three-month blanking period
time frame: 3-12 months after the first pulmonary vein isolation
description: antiarrhythmic drugs: sotalol, amiodarone, propafenon
measure: reablation
time frame: 3-12 months after the first pulmonary vein isolation
description: repeated left atrial ablation is performed due to atrial fibrillation or left atrial tachycardia recurrence
measure: major complications of pulmonary vein isolation
time frame: through 1 year follow-up after the first pulmonary vein isolation
description: major complications: requiring surgical intervention or causing prolonged hospitalisation
measure: MACE
time frame: through 1 year follow-up after the first pulmonary vein isolation
description: major adverse cardiac events
measure: death
time frame: through 1 year follow-up after the first pulmonary vein isolation
arm group label: persistent atrial fibrillation
description: invasive LA pressure monitoring, LA voltage map creation, LA strain evaluation by transthoracal echocardiography, LA scar-mapping by cardiac MRI, defining biomarkers from blood samples during atrial fibrillation and after pulmonary vein isolation in sinus rhythm
intervention type: Diagnostic Test
intervention name: LA pressure, voltage map, strain, scar-map, blood sampling
description: invasive LA pressure monitoring, LA voltage map creation, LA strain evaluation by transthoracal echocardiography, LA scar-mapping by cardiac MRI, defining biomarkers from blood samples during atrial fibrillation and after pulmonary vein isolation in sinus rhythm
arm group label: persistent atrial fibrillation
intervention type: Procedure
intervention name: pulmonary vein isolation
description: pulmonary vein isolation without creating additional ablation lesions
arm group label: persistent atrial fibrillation
venous blood samples
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Laszlo Geller, MD PhD
role: Principal Investigator
affiliation: Heart and Vascular Center of Semmelweis University
last name: Bela Merkely, MD PhD DSc
role: Study Director
affiliation: Heart and Vascular Center of Semmelweis University
last name: Szilvia Herczeg, MD
phone: 0036206663198
email: herczeg.szilvia@med.semmelweis-univ.hu
last name: Nandor Szegedi, MD
phone: 0036206663442
email: szegedi.nandor@med.semmelweis-univ.hu
facility: 
status: Recruiting
contact: 
country: Hungary
responsible party type: Sponsor
mesh term: Atrial Fibrillation
sharing ipd: No