A Study of a Lifestyle Program on Recurrent Atrial Fibrillation

NCT ID: NCT06155357

Last Updated: 2024-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-30

Study Completion Date

2026-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Atrial Fibrillation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Multicomponent lifestyle intervention program

Intervention Type BEHAVIORAL

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Amanda R. Bonikowske

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Amanda Bonikowske

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

23-003042

Identifier Type: -

Identifier Source: org_study_id