We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study is currently recruiting participants.
Verified October 2017 by Texas Cardiac Arrhythmia Research Foundation
Sponsor:
ClinicalTrials.gov Identifier:
NCT02219841
First Posted: August 19, 2014
Last Update Posted: October 19, 2017
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.
Information provided by (Responsible Party):
Texas Cardiac Arrhythmia Research Foundation
  Purpose

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.


Condition Intervention
Atrial Fibrillation Obesity Procedure: radiofrequency catheter ablation

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Impact of Life-Style Modification On Ablation Outcome in Atrial Fibrillation

Resource links provided by NLM:


Further study details as provided by Texas Cardiac Arrhythmia Research Foundation:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Other Outcome Measures:
  • Weight loss [ Time Frame: 1 year ]
    Weight loss following calorie-controlled diet and monitored exercise for 12 months


Estimated Enrollment: 50
Study Start Date: August 2014
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
No intervention group
Receive general life-style advice and information on heart healthy diet Undergo catheter ablation for AFib
Procedure: radiofrequency catheter ablation
Other Name: RFCA
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
Other Name: RFCA

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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02219841


Contacts
Contact: Mitra Mohanty, MD MS FHRS 5127842651 mitra1989@gmail.com
Contact: Tamara Metz, RN 512-544-8176 Tamara.Metz@stdavids.com

Locations
United States, Texas
Texas Cardiac Arrhythmia Institute, St. david's Medical Center Recruiting
Austin, Texas, United States, 78705
Contact: Mitra Mohanty, MD MS FHRS    512-544-8198    mitra.mohanty@stdavids.com   
Contact: Tamara Metz, RN    512-544-8176    Tamara.Metz@stdavids.com   
Sponsors and Collaborators
Texas Cardiac Arrhythmia Research Foundation
Investigators
Principal Investigator: Andrea Natale, MD Texas Cardiac Arrhythmia Research Foundation
Principal Investigator: Mitra Mohanty, MD Texas Cardiac Arrhythmia Institiute
  More Information

Responsible Party: Texas Cardiac Arrhythmia Research Foundation
ClinicalTrials.gov Identifier: NCT02219841     History of Changes
Other Study ID Numbers: TCAI_ISOLATE
First Submitted: July 31, 2014
First Posted: August 19, 2014
Last Update Posted: October 19, 2017
Last Verified: October 2017

Keywords provided by Texas Cardiac Arrhythmia Research Foundation:
Obesity, low-calorie diet, exercise, atrial fibrillation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes