Post-ablation Alcohol Impacts Arrhythmia Recurrence, Quality of Life and Cognition in AF

Part of paid clinical trials in Austin, Texas.

Sponsor: Texas Cardiac Arrhythmia Research Foundation
Study ID: NCT05510167
Status: Recruiting

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Conditions

Atrial Fibrillation

Eligibility Criteria

Sex: ALL
Age: 18 Years - 85 Years
Healthy Volunteers: Not accepted

Interventions

Study arm — BEHAVIORAL
Participants will be asked to completely abstain from drinking or consume 2 or less drinks per week for 8 months following catheter ablation

Study Details

Earlier studies have shown a dose-dependent relationship between alcohol intake and incident atrial fibrillation (AF) as well as a causal link with several risk factors for AF such as hypertension, obesity and sleep apnea. However, the effect of drinking (alcohol) on post-ablation outcome such as arrhythmia recurrence, quality of life (QoL) and cognitive function in AF patients is unclear. Therefore, we aim to find the answer for a very frequently asked question, "is it safe to continue drinking alcohol (at the pre-ablation level) following catheter ablation OR should the intake be reduced for better outcome?", in this randomized trial.

Key Dates

First listed: Aug 22, 2022
Start date: Aug 22, 2022
Status verified: Sep 2026
Primary completion: Aug 31, 2027
Completion: Aug 31, 2027

Study Design

Enrollment: 184 participants (estimated)
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Arms

Active Comparator: Study
Complete abstinence or ≤2 drinks/week in group 1 during the study period
Active Comparator: Control
Allowed to continue their pre-ablation drinking habit