A Study of a Lifestyle Program on Recurrent Atrial Fibrillation

Not Applicable

Withdrawn

• Conditions: Atrial Fibrillation
• Interventions: Behavioral: Multicomponent lifestyle intervention program

• Registration Number: NCT06155357
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-24
• Study First Submitted QC: 2023-12-01
• Study First Posted: 2023-12-04
• Study Start: 2024-09
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-02
• Last Update Posted: 2024-12-04
• Primary Completion: 2025-08
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 40

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lifestyle Interventions Pre-Procedure	Multicomponent lifestyle intervention program	Subjects with paroxysmal or persistent atrial fibrillation (AF) who are scheduled to undergo elective catheter ablation of AF will participate in a 12-week multicomponent lifestyle intervention program.

Primary Outcome Measures

Name	Time	Method
Number of Cardiac Rehab Sessions Attended	12 weeks	Number of cardiac rehab sessions attended during the 12-week multicomponent lifestyle intervention program.

Secondary Outcome Measures

Name	Time	Method
Change in weight loss	Baseline, 12 weeks	Change in weight loss pre \& post multicomponent lifestyle intervention program reported in kilograms (kg)
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 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).

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States