Atrial FibrillationISOLATENCT02219841
Impact of Life-Style Modification On Ablation Outcome in Atrial Fibrillation
An observational study of Atrial Fibrillation and Obesity, run by Texas Cardiac Arrhythmia Research Foundation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation, Obesity
- What is being tested?
- radiofrequency catheter ablation
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Texas Cardiac Arrhythmia Institute, St. david's Medical Center
Austin, Texas, 78705
Mitra Mohanty, MD MS FHRS, 512-544-8198, mitra.mohanty@stdavids.com
Tamara Metz, RN, 512-544-8176, Tamara.Metz@stdavids.com
About this study
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.
Read the 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:
- Change in QoL It will be evaluated by a validated AF specific questionnaire (AFEQT) at baseline and 6 and 12 months post-procedure
- 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
- Atrial Fibrillation, Obesity
- Being tested
- radiofrequency catheter ablation
- Keywords
- Obesity, low-calorie diet, exercise, atrial fibrillation
- Medical subject headings
- Atrial Fibrillation, Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiofrequency catheter ablationProcedure or surgery
Also called RFCA
| Study group | Role | What they receive |
|---|---|---|
| No intervention group | Receive general life-style advice and information on heart healthy diet Undergo catheter ablation for AFib Receives: 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 Receives: Procedure: radiofrequency catheter ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year post-ablation
Secondary outcomes (1)
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionAug 2020 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Texas Cardiac Arrhythmia Research Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrea Natale, MD, Principal investigator, Texas Cardiac Arrhythmia Research FoundationMitra Mohanty, MD, Principal investigator, Texas Cardiac Arrhythmia Institiute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02219841
- Sponsor's protocol ID
- TCAI_ISOLATE
- Acronym
- ISOLATE
- Status last verified
- Sep 2019
- First submitted
- 31 Jul 2014
- Last updated
- 11 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Life-Style Modification On Ablation Outcome in Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT02219841
- Acronym / sponsor ID
- ISOLATE / TCAI_ISOLATE
- Conditions
- Atrial Fibrillation, Obesity
- Keywords
- Obesity, low-calorie diet, exercise, atrial fibrillation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Texas Cardiac Arrhythmia Research FoundationUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 19 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Change in QoL It will be evaluated by a validated AF specific questionnaire (AFEQT) at baseline and 6 and 12 months post-procedure
- 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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No intervention group | – | Procedure: radiofrequency catheter ablationReceive general life-style advice and information on heart healthy diet Undergo catheter ablation for AFib |
| Life-style intervention | – | Procedure: radiofrequency catheter ablationpatients 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| radiofrequency catheter ablationAlso: RFCA | Procedure or surgery | Life-style intervention, No intervention group |
Primary outcome
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
1 secondary outcome
Quality of Life
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2019.
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Natale, MD principal investigator
Texas Cardiac Arrhythmia Research Foundation
Mitra Mohanty, MD principal investigator
Texas Cardiac Arrhythmia Institiute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Obesity, run by Texas Cardiac Arrhythmia Research Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mitra Mohanty, MD MS FHRS (5127842651, mitra1989@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arrhythmia recurrence (time frame: 1 year post-ablation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2019.