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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:
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No intervention group | Receive general life-style advice and information on heart healthy diet Undergo catheter ablation for AFib |
| |
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| radiofrequency catheter ablation | Procedure |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Arrhythmia recurrence | 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 | 1 year post-ablation |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life | 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 | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Weight loss | Weight loss following calorie-controlled diet and monitored exercise for 12 months | 1 year |
Inclusion Criteria:
Exclusion Criteria:
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A total of 50 consecutive AF patients with BMI 26-40, will be enrolled in this pilot study and randomized to 2 groups in a 1:1 design (25 per group).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mitra Mohanty, MD MS FHRS | Contact | 5127842651 | mitra1989@gmail.com | |
| Tamara Metz, RN | Contact | 512-544-8176 | Tamara.Metz@stdavids.com |
| Name | Affiliation | Role |
|---|---|---|
| Andrea Natale, MD | Texas Cardiac Arrhythmia Research Foundation | Principal Investigator |
| Mitra Mohanty, MD | Texas Cardiac Arrhythmia Institiute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas Cardiac Arrhythmia Institute, St. david's Medical Center | Recruiting | Austin | Texas | 78705 | United States |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D009765 | Obesity |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D017115 | Catheter Ablation |
| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D001519 | Behavior |
| D013514 |
| Surgical Procedures, Operative |