A Study of a Lifestyle Program on Recurrent Atrial Fibrillation

Atrial Fibrillation Clinical Trial

Official title:

Pre-habilitation Multicomponent Lifestyle Program for Patients Undergoing Ablation for Atrial Fibrillation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06155357
• Other study ID #: 23-003042
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2024
• Est. completion date: August 2026

Study information

• Verified date: February 2024
• Source: Mayo Clinic
• Contact: Preventive/Vascular Research Team
• Phone: (507)538-7425
• Email: bonikowske.amanda[@]mayo.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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).

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Behavioral:
• Multicomponent 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.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

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