What this study is
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.
What's being tested
- Study arm
Intervention · 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
- Official title
- Impact of Post-ablation Alcohol Intake on Arrhythmia Recurrence, Quality of Life and Cognition in Patients With Atrial Fibrillation
- Sponsor
- Texas Cardiac Arrhythmia Research Foundation
- Conditions
- Atrial Fibrillation
- Enrolling
- 184 people
- Starts
- 2022-08-22
- Est. completion
- 2027-08
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 85 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openTexas Cardiac Arrhythmia Institute, St. David's Medical Center
Austin, Texas, United States
Recruiting
Study team
Sponsor
Texas Cardiac Arrhythmia Research Foundation
Study ID TCAI_PLATINUM
Principal investigator
Andrea Natale
Texas Cardiac Arrhythmia Institute, St.
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.