Impact of Life-Style Modification On Ablation Outcome in Atrial Fibrillation
NCT ID: NCT02219841
Last Updated: 2019-09-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
50 participants
OBSERVATIONAL
2014-08-31
2022-12-31
Brief Summary
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Hypothesis: Weight loss and management by adoption of strict diet and exercise regimen improves the chances of freedom from recurrence following catheter ablation.
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Detailed Description
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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
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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No intervention group
Receive general life-style advice and information on heart healthy diet Undergo catheter ablation for AFib
radiofrequency catheter ablation
Life-style intervention
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
radiofrequency catheter ablation
Interventions
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radiofrequency catheter ablation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. AF patient undergoing first catheter ablation, at least 3 months after the enrollment
3. BMI: ≥ 26-40
4. Willing to be compliant with the weight-reduction program
5. Willing to provide informed, written consent
Exclusion Criteria
2. Participation in another weight loss program in \< 3 months
3. Musculoskeletal conditions limiting exercise capacity
4. Insulin-dependent diabetes
5. Severe valvular heart disease or cardiomyopathy
6. Heavy drinking (\>14 standard drinks/week for men and \>7/ week for women)
7. Inability to provide informed consent
18 Years
80 Years
ALL
No
Sponsors
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Texas Cardiac Arrhythmia Research Foundation
OTHER
Responsible Party
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Principal Investigators
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Andrea Natale, MD
Role: PRINCIPAL_INVESTIGATOR
Texas Cardiac Arrhythmia Research Foundation
Mitra Mohanty, MD
Role: PRINCIPAL_INVESTIGATOR
Texas Cardiac Arrhythmia Institiute
Locations
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Texas Cardiac Arrhythmia Institute, St. david's Medical Center
Austin, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TCAI_ISOLATE
Identifier Type: -
Identifier Source: org_study_id
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