Atrial Fibrillation Clinical Trial
Official title:
Pre-habilitation Multicomponent Lifestyle Program for Patients Undergoing Ablation for Atrial Fibrillation
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.
Status | Not yet recruiting |
Enrollment | 40 |
Est. completion date | August 2026 |
Est. primary completion date | August 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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). |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic in Rochester | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Cardiac Rehab Sessions Attended | Number of cardiac rehab sessions attended during the 12-week multicomponent lifestyle intervention program. | 12 weeks | |
Secondary | Number of subjects with Atrial Fibrillation (AF) recurrence | Number of subjects with AF recurrence will be assessed by chart review and clinically indicated holter monitor. | 1 year | |
Secondary | Change in weight loss | Change in weight loss pre & post multicomponent lifestyle intervention program reported in kilograms (kg) | Baseline, 12 weeks | |
Secondary | Change in exercise capacity | 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. | Baseline, 12 weeks | |
Secondary | Change in Atrial Fibrillation (AF) Symptom severity | 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). | Baseline, 12 weeks, 6 months, 1 year |
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