<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/NCT02219841</url>
  </required_header>
  <id_info>
    <org_study_id>TCAI_ISOLATE</org_study_id>
    <nct_id>NCT02219841</nct_id>
  </id_info>
  <brief_title>Impact of Life-Style Modification On Ablation Outcome in Atrial Fibrillation</brief_title>
  <acronym>ISOLATE</acronym>
  <official_title>Impact of Life-Style Modification On Ablation Outcome in Atrial Fibrillation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Texas Cardiac Arrhythmia Research Foundation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Texas Cardiac Arrhythmia Research Foundation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This prospective randomized pilot study aims to evaluate the impact of aggressive life style&#xD;
      modification in terms of calorie-controlled diet and supervised exercise on outcome of&#xD;
      catheter ablation in overweight and obese patients with atrial fibrillation.&#xD;
&#xD;
      Hypothesis: Weight loss and management by adoption of strict diet and exercise regimen&#xD;
      improves the chances of freedom from recurrence following catheter ablation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objective: To examine the impact of a planned life-style modification program including&#xD;
      calorie-controlled diet and supervised exercise before and after the AF ablation on quality&#xD;
      of life (QoL) and long-term arrhythmia recurrence in overweight and obese patients with&#xD;
      atrial fibrillation.&#xD;
&#xD;
      Endpoints:&#xD;
&#xD;
      Primary: AF recurrence following index ablation procedure It will be assessed at 3, 6 and 12&#xD;
      months after the procedure by event recorders, 12-lead ECG and Holter monitoring Any episode&#xD;
      of AF/AFL/AT &gt; 30 sec will be considered as a recurrence. Episodes that occur during the&#xD;
      first 3 months after the procedure (blanking period) will not be considered as recurrence.&#xD;
&#xD;
      Secondary:&#xD;
&#xD;
        1. Change in QoL It will be evaluated by a validated AF specific questionnaire (AFEQT) at&#xD;
           baseline and 6 and 12 months post-procedure&#xD;
&#xD;
        2. Change in AF symptom severity. This will be measured by AF symptom severity and burden&#xD;
           questionnaire at baseline and 6 and 12 months post-procedure&#xD;
&#xD;
      DIET:&#xD;
&#xD;
      Participants in the intervention group will receive individual counseling sessions with an&#xD;
      experienced dietitian, who will prepare personalized diet plan based on their comorbidities&#xD;
      and preferences.&#xD;
&#xD;
      To accomplish weight loss, the diet menu will be planned to reduce daily food intake by ≥ 500&#xD;
      calories depending on their baseline body weight.&#xD;
&#xD;
      Patients enrolled in the control group will be provided advice on heart-healthy diet and&#xD;
      active life style.&#xD;
&#xD;
      EXERCISE:&#xD;
&#xD;
      Supervised and monitored exercise will be conducted in St. David's Cardiac Rehabilitation for&#xD;
      3 months starting before or 7-10 days after the ablation.&#xD;
&#xD;
      After ablation, patients will continue individualized home-exercise program for 1 year.&#xD;
&#xD;
      QoL Survey:&#xD;
&#xD;
      The AF Effect on Quality of Life survey (AFEQT) questionnaire will be used at baseline and 6&#xD;
      and 12 months post procedure.&#xD;
&#xD;
      Symptom Severity Survey:&#xD;
&#xD;
      This will be measured by AF symptom severity and burden questionnaire at baseline and 6 and&#xD;
      12 months post-procedure&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2014</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">August 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Arrhythmia recurrence</measure>
    <time_frame>1 year post-ablation</time_frame>
    <description>Arrhythmia recurrence will be monitored at 3-month intervals with Holter monitor, event recorder, cardiology evaluation and ECG. Recurrence is defined as any episode of AF/ atrial flutter/ atrial tachycardia of &gt;30 seconds duration with or without anti-arrhythmic drugs, occurring after 3 months of blanking period following catheter ablation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of Life</measure>
    <time_frame>1 year</time_frame>
    <description>The AF Effect on Quality of Life survey (AFEQT questionnaire will be used at baseline and 6 and 12 months post procedure. It is a validated self-administered questionnaire of 20 questions for AF patients that evaluates health-related QoL across 3 domains; symptoms, daily activity and treatment concerns</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Weight loss</measure>
    <time_frame>1 year</time_frame>
    <description>Weight loss following calorie-controlled diet and monitored exercise for 12 months</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Atrial Fibrillation</condition>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>No intervention group</arm_group_label>
    <description>Receive general life-style advice and information on heart healthy diet Undergo catheter ablation for AFib</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Life-style intervention</arm_group_label>
    <description>patients will receive personilized low-calorie diet menu and undergo supervised exercise in the cardiac rehabilitation facility for 3 months before ablation with an aim of loosing &gt;10% of body weight. They will continue diet and exercise for 1 year following ablation procedure Will receive catheter ablation for AFib</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>radiofrequency catheter ablation</intervention_name>
    <arm_group_label>Life-style intervention</arm_group_label>
    <arm_group_label>No intervention group</arm_group_label>
    <other_name>RFCA</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        A total of 50 consecutive AF patients with BMI 26-40, will be enrolled in this pilot study&#xD;
        and randomized to 2 groups in a 1:1 design (25 per group).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age: &gt; 18 years&#xD;
&#xD;
          2. AF patient undergoing first catheter ablation, at least 3 months after the enrollment&#xD;
&#xD;
          3. BMI: ≥ 26-40&#xD;
&#xD;
          4. Willing to be compliant with the weight-reduction program&#xD;
&#xD;
          5. Willing to provide informed, written consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Chronic obstructive lung disease (COPD)&#xD;
&#xD;
          2. Participation in another weight loss program in &lt; 3 months&#xD;
&#xD;
          3. Musculoskeletal conditions limiting exercise capacity&#xD;
&#xD;
          4. Insulin-dependent diabetes&#xD;
&#xD;
          5. Severe valvular heart disease or cardiomyopathy&#xD;
&#xD;
          6. Heavy drinking (&gt;14 standard drinks/week for men and &gt;7/ week for women)&#xD;
&#xD;
          7. Inability to provide informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andrea Natale, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Texas Cardiac Arrhythmia Research Foundation</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mitra Mohanty, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Texas Cardiac Arrhythmia Institiute</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mitra Mohanty, MD MS FHRS</last_name>
    <phone>5127842651</phone>
    <email>mitra1989@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Tamara Metz, RN</last_name>
    <phone>512-544-8176</phone>
    <email>Tamara.Metz@stdavids.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Texas Cardiac Arrhythmia Institute, St. david's Medical Center</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78705</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mitra Mohanty, MD MS FHRS</last_name>
      <phone>512-544-8198</phone>
      <email>mitra.mohanty@stdavids.com</email>
    </contact>
    <contact_backup>
      <last_name>Tamara Metz, RN</last_name>
      <phone>512-544-8176</phone>
      <email>Tamara.Metz@stdavids.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>July 31, 2014</study_first_submitted>
  <study_first_submitted_qc>August 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 19, 2014</study_first_posted>
  <last_update_submitted>September 9, 2019</last_update_submitted>
  <last_update_submitted_qc>September 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 11, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Obesity, low-calorie diet, exercise, atrial fibrillation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
  </condition_browse>
  <!-- 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/NCT02219841
org study id: TCAI_ISOLATE
nct id: NCT02219841
lead sponsor: 
has dmc: No
This prospective randomized pilot study aims to evaluate the impact of aggressive life style
      modification in terms of calorie-controlled diet and supervised exercise on outcome of
      catheter ablation in overweight and obese patients with atrial fibrillation.

      Hypothesis: Weight loss and management by adoption of strict diet and exercise regimen
      improves the chances of freedom from recurrence following catheter ablation.
Objective: To examine the impact of a planned life-style modification program including
      calorie-controlled diet and supervised exercise before and after the AF ablation on quality
      of life (QoL) and long-term arrhythmia recurrence in overweight and obese patients with
      atrial fibrillation.

      Endpoints:

      Primary: AF recurrence following index ablation procedure It will be assessed at 3, 6 and 12
      months after the procedure by event recorders, 12-lead ECG and Holter monitoring Any episode
      of AF/AFL/AT > 30 sec will be considered as a recurrence. Episodes that occur during the
      first 3 months after the procedure (blanking period) will not be considered as recurrence.

      Secondary:

        1. Change in QoL It will be evaluated by a validated AF specific questionnaire (AFEQT) at
           baseline and 6 and 12 months post-procedure

        2. Change in AF symptom severity. This will be measured by AF symptom severity and burden
           questionnaire at baseline and 6 and 12 months post-procedure

      DIET:

      Participants in the intervention group will receive individual counseling sessions with an
      experienced dietitian, who will prepare personalized diet plan based on their comorbidities
      and preferences.

      To accomplish weight loss, the diet menu will be planned to reduce daily food intake by ≥ 500
      calories depending on their baseline body weight.

      Patients enrolled in the control group will be provided advice on heart-healthy diet and
      active life style.

      EXERCISE:

      Supervised and monitored exercise will be conducted in St. David's Cardiac Rehabilitation for
      3 months starting before or 7-10 days after the ablation.

      After ablation, patients will continue individualized home-exercise program for 1 year.

      QoL Survey:

      The AF Effect on Quality of Life survey (AFEQT) questionnaire will be used at baseline and 6
      and 12 months post procedure.

      Symptom Severity Survey:

      This will be measured by AF symptom severity and burden questionnaire at baseline and 6 and
      12 months post-procedure
observational model: Case-Control
time perspective: Prospective
measure: Arrhythmia recurrence
time frame: 1 year post-ablation
description: Arrhythmia recurrence will be monitored at 3-month intervals with Holter monitor, event recorder, cardiology evaluation and ECG. Recurrence is defined as any episode of AF/ atrial flutter/ atrial tachycardia of >30 seconds duration with or without anti-arrhythmic drugs, occurring after 3 months of blanking period following catheter ablation
measure: Quality of Life
time frame: 1 year
description: The AF Effect on Quality of Life survey (AFEQT questionnaire will be used at baseline and 6 and 12 months post procedure. It is a validated self-administered questionnaire of 20 questions for AF patients that evaluates health-related QoL across 3 domains; symptoms, daily activity and treatment concerns
measure: Weight loss
time frame: 1 year
description: Weight loss following calorie-controlled diet and monitored exercise for 12 months
arm group label: No intervention group
description: Receive general life-style advice and information on heart healthy diet Undergo catheter ablation for AFib
arm group label: Life-style intervention
description: patients will receive personilized low-calorie diet menu and undergo supervised exercise in the cardiac rehabilitation facility for 3 months before ablation with an aim of loosing >10% of body weight. They will continue diet and exercise for 1 year following ablation procedure Will receive catheter ablation for AFib
intervention type: Procedure
intervention name: radiofrequency catheter ablation
arm group label: Life-style intervention
arm group label: No intervention group
other name: RFCA
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Andrea Natale, MD
role: Principal Investigator
affiliation: Texas Cardiac Arrhythmia Research Foundation
last name: Mitra Mohanty, MD
role: Principal Investigator
affiliation: Texas Cardiac Arrhythmia Institiute
last name: Mitra Mohanty, MD MS FHRS
phone: 5127842651
email: mitra1989@gmail.com
last name: Tamara Metz, RN
phone: 512-544-8176
email: Tamara.Metz@stdavids.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Sponsor
mesh term: Atrial Fibrillation