Recruiting

Alcohol Intake

Sponsor:

Texas Cardiac Arrhythmia Research Foundation

Code:

NCT05510167

Conditions

Atrial Fibrillation

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Study arm

Study Details

Brief summary:

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.

Conditions

Atrial Fibrillation

Study ID

NCT05510167

Start date

Aug 22, 2022

Status verified date

Sep, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • AF patients that regularly consume >5 alcoholic drink (\*12 g of pure alcohol/drink)/week
  • Paroxysmal or persistent AF
  • First catheter ablation History of alcohol-induced arrhythmia
  • Willing to sign the written informed consent

Exclusion Criteria:

  • Binge drinkers (alcohol dependence)
  • Non-drinkers
  • LVEF <35%
  • Psychiatric conditions
  • MoCA score ≤ 17 on Montreal Cognitive Assessment (MoCA)
  • Patients with established dementia
  • Medically unstable patients (acute/unstable or poorly controlled problems that would demand focused, relatively urgent or emergent medical attention)
  • Unwilling for alcohol-abstinence
  • Long-standing persistence AF
  • Patient under legal protection
  • Pregnancy

Study Design

Enrollment

184 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

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

Interventions

Study arm

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

Primary outcome measure

  • Arrhythmia recurrence [ Time Frame: 8 months after the ablation procedure for AF ]

Central Contacts and Locations

Central contacts

Andrea Natale

5125448186dr.natale@gmail.com

Sanghamitra Mohanty

5127842651mitra1989@gmail.com

Locations

Texas Cardiac Arrhythmia Institute, St. David's Medical Center

Recruiting

Austin, Texas, United States, 78705

Contacts

5127842651mitra1989@gmail.com

More Information

Sponsor

Texas Cardiac Arrhythmia Research Foundation

Last update posted

Sep 14, 2026

Last verified

Sep, 2026

Keywords

  • Alcohol
  • AF
  • catheter ablation
  • recurrence

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-15. This information was provided to ClinicalTrials.gov by Texas Cardiac Arrhythmia Research Foundation on 2026-09-14.