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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02219841
Recruitment Status : Recruiting
First Posted : August 19, 2014
Last Update Posted : September 11, 2019
Sponsor:
Information provided by (Responsible Party):
Texas Cardiac Arrhythmia Research Foundation

Tracking Information
First Submitted Date July 31, 2014
First Posted Date August 19, 2014
Last Update Posted Date September 11, 2019
Study Start Date August 2014
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 15, 2014)
Arrhythmia recurrence [ Time Frame: 1 year post-ablation ]
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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02219841 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: August 15, 2014)
Quality of Life [ Time Frame: 1 year ]
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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 17, 2017)
Weight loss [ Time Frame: 1 year ]
Weight loss following calorie-controlled diet and monitored exercise for 12 months
Original Other Pre-specified Outcome Measures
 (submitted: August 15, 2014)
Weight loss [ Time Frame: 1 year ]
Weight loss following calorie-controlled diet and monitored exercise for 15 months 93 months pre-ablation + 12-months post-ablation)
 
Descriptive Information
Brief Title Impact of Life-Style Modification On Ablation Outcome in Atrial Fibrillation
Official Title Impact of Life-Style Modification On Ablation Outcome in Atrial Fibrillation
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.

Detailed Description

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

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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).
Condition
  • Atrial Fibrillation
  • Obesity
Intervention Procedure: radiofrequency catheter ablation
Other Name: RFCA
Study Groups/Cohorts
  • No intervention group
    Receive general life-style advice and information on heart healthy diet Undergo catheter ablation for AFib
    Intervention: 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
    Intervention: Procedure: radiofrequency catheter ablation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 15, 2014)
50
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2022
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Age: > 18 years
  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:

  1. Chronic obstructive lung disease (COPD)
  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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Mitra Mohanty, MD MS FHRS 5127842651 mitra1989@gmail.com
Contact: Tamara Metz, RN 512-544-8176 Tamara.Metz@stdavids.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02219841
Other Study ID Numbers TCAI_ISOLATE
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Texas Cardiac Arrhythmia Research Foundation
Study Sponsor Texas Cardiac Arrhythmia Research Foundation
Collaborators Not Provided
Investigators
Principal Investigator: Andrea Natale, MD Texas Cardiac Arrhythmia Research Foundation
Principal Investigator: Mitra Mohanty, MD Texas Cardiac Arrhythmia Institiute
PRS Account Texas Cardiac Arrhythmia Research Foundation
Verification Date September 2019