A Study of a Lifestyle Program on Recurrent Atrial Fibrillation

Mayo Clinic

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Conditions

Atrial Fibrillation

Interventions

Multicomponent lifestyle intervention programBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

Number of Cardiac Rehab Sessions Attended

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

Time frame: 12 weeks

Secondary Outcomes

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.

Time frame: 1 year

Change in weight loss

Change in weight loss pre \& post multicomponent lifestyle intervention program reported in kilograms (kg)

Time frame: Baseline, 12 weeks

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.

Time frame: Baseline, 12 weeks

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).

Time frame: Baseline, 12 weeks, 6 months, 1 year

Data from ClinicalTrials.gov

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