Atrial Fibrillation
Conditions
Brief summary
The purpose of this study is to examine the impact of a comprehensive lifestyle intervention, including cardiac rehabilitation, prior to catheter ablation (a procedure to stop abnormal electrical signals in the heart), on Atrial Fibrillation (AF)-related symptoms.
Interventions
BEHAVIORALMulticomponent lifestyle intervention program
The multicomponent lifestyle intervention program is targeted at risk factor management, increased exercise capacity, and weight loss. The program will commence upon order/referral for ablation. Ablation would occur during the lifestyle program and the program will be continued after the ablation to complete 12 weeks or up to 36 exercise sessions.
Sponsors
Mayo Clinic
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Paroxysmal or persistent atrial fibrillation. * Planned elective catheter ablation of AF.
Exclusion criteria
* Prior catheter ablation. * Presence of pacemaker/ICD. * Longstanding persistent AF. * Uncontrolled AF (including poor rate control or tachycardia-mediated cardiomyopathy requiring urgent cardioversion/ablation at the clinician's assessment).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Cardiac Rehab Sessions Attended | 12 weeks | Number of cardiac rehab sessions attended during the 12-week multicomponent lifestyle intervention program. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects with Atrial Fibrillation (AF) recurrence | 1 year | Number of subjects with AF recurrence will be assessed by chart review and clinically indicated holter monitor. |
| Change in weight loss | Baseline, 12 weeks | Change in weight loss pre & post multicomponent lifestyle intervention program reported in kilograms (kg) |
| Change in exercise capacity | Baseline, 12 weeks | Change in exercise capacity will be assessed by 6-minute walk test pre & post multicomponent lifestyle intervention program. Measurement (meters) of distance a person can walk on flat ground in 6 minutes. |
| Change in Atrial Fibrillation (AF) Symptom severity | Baseline, 12 weeks, 6 months, 1 year | Change in AF Symptom Severity will be assessed by the Atrial Fibrillation Severity Scale (AFSS) questionnaire. The AFSS questionnaire is a 19-item self-administered questionnaire developed to capture subjective and objective ratings of AF related symptoms, health care utilization, and AF disease burden, including frequency, duration, and severity of episodes. Higher scores indicate higher symptom severity (range of 0-35). |
Countries
United States
Outcome results
None listed