Impact of Life-Style Modification On Ablation Outcome in Atrial Fibrillation

NCT02219841 | Unknown

• 1 other identifier: TCAI_ISOLATE
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atrial Fibrillation; Obesity

Keywords

Obesity, low-calorie diet, exercise, atrial fibrillation

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Quality of Life

  1 year

Other Outcomes (1)

• Weight loss

  1 year

Study Arms (2)

No intervention group

Receive general life-style advice and information on heart healthy diet Undergo catheter ablation for AFib

Procedure: 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

Procedure: radiofrequency catheter ablation

Interventions

radiofrequency catheter ablation PROCEDURE

Also known as: RFCA

Life-style intervention; No intervention group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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).

You may qualify if:

• Age: \> 18 years
• AF patient undergoing first catheter ablation, at least 3 months after the enrollment
• BMI: ≥ 26-40
• Willing to be compliant with the weight-reduction program
• Willing to provide informed, written consent

You may not qualify if:

• Chronic obstructive lung disease (COPD)
• Participation in another weight loss program in \< 3 months
• Musculoskeletal conditions limiting exercise capacity
• Insulin-dependent diabetes
• Severe valvular heart disease or cardiomyopathy
• Heavy drinking (\>14 standard drinks/week for men and \>7/ week for women)
• Inability to provide informed consent

Sponsors & Collaborators

• Texas Cardiac Arrhythmia Research Foundation: lead

Study Sites (1)

Texas Cardiac Arrhythmia Institute, St. david's Medical Center

Austin, Texas, 78705, United States

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Obesity; Motor Activity

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Andrea Natale, MD

  Texas Cardiac Arrhythmia Research Foundation

  PRINCIPAL INVESTIGATOR

• Mitra Mohanty, MD

  Texas Cardiac Arrhythmia Institiute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mitra Mohanty, MD MS FHRS

CONTACT

5127842651; mitra1989@gmail.com

Tamara Metz, RN

CONTACT

512-544-8176; Tamara.Metz@stdavids.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2014
• First Posted: August 19, 2014
• Study Start: August 1, 2014
• Primary Completion: August 1, 2020
• Study Completion: December 1, 2022
• Last Updated: September 11, 2019

Record last verified: 2019-09

Locations

US (1)