A Study of a Lifestyle Program on Recurrent Atrial Fibrillation

NCT06155357 | Withdrawn

• 1 other identifier: 23-003042
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Number of Cardiac Rehab Sessions Attended

  Number of cardiac rehab sessions attended during the 12-week multicomponent lifestyle intervention program.

  12 weeks

Secondary Outcomes (4)

• Number of subjects with Atrial Fibrillation (AF) recurrence

  1 year

• Change in weight loss

  Baseline, 12 weeks

• Change in exercise capacity

  Baseline, 12 weeks

• Change in Atrial Fibrillation (AF) Symptom severity

  Baseline, 12 weeks, 6 months, 1 year

Study Arms (2)

Lifestyle Interventions Pre-Procedure

EXPERIMENTAL

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

Standard of Care

NO INTERVENTION

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.

Interventions

Multicomponent lifestyle intervention program 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.

Lifestyle Interventions Pre-Procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Paroxysmal or persistent atrial fibrillation.
• Planned elective catheter ablation of AF.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Amanda Bonikowske

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 24, 2023
• First Posted: December 4, 2023
• Study Start: September 1, 2024
• Primary Completion: August 1, 2025
• Study Completion (Estimated): August 1, 2026
• Last Updated: December 4, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)