A Study of a Lifestyle Program on Recurrent Atrial Fibrillation

Sponsor

Mayo Clinic (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06155357

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation	Behavioral: Multicomponent lifestyle intervention program	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2024

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lifestyle Interventions Pre-Procedure 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.	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.
No Intervention: Standard of Care Subjects who have previously undergone catheter ablation of atrial fibrillation (AF) as part of their standard of care will have medical chart review completed to gather information.

Arm

Intervention/Treatment

Experimental: Lifestyle Interventions Pre-Procedure

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.

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.

No Intervention: Standard of Care

Subjects who have previously undergone catheter ablation of atrial fibrillation (AF) as part of their standard of care will have medical chart review completed to gather information.

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Rochester	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

Mayo Clinic

Investigators

Principal Investigator: Amanda Bonikowske, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Mayo Clinic Clinical Trials

Publications

None provided.

Responsible Party:

Amanda R. Bonikowske, Principal Investigator, Mayo Clinic

ClinicalTrials.gov Identifier:

NCT06155357

Other Study ID Numbers:

23-003042

First Posted:

Dec 4, 2023

Last Update Posted:

Dec 4, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Atrial Fibrillation

Study Results

No Results Posted as of Dec 4, 2023