ClinicalTrials.gg
RecruitingNCT05510167PLATINUMUpdated Sep 14, 2026

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

An interventional study of Study arm in Atrial Fibrillation, sponsored by Texas Cardiac Arrhythmia Research Foundation. Recruiting at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-09-14.

Sponsored by Texas Cardiac Arrhythmia Research Foundation · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Aug 2022; still recruiting 4 years 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
184
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

Read the detailed description
  1. BACKGROUND Earlier studies have not only reported alcohol-abstinence to be associated with lower recurrence of AF in patients receiving non-ablative antiarrhythmic therapy, but also unfavorable outcome among regular drinkers (high frequency and quantity) compared to non-drinkers undergoing AF ablation (1-3). In a meta-analysis of 14 studies, where the effect measures for AF associated with highest vs lowest alcohol intake were pooled for analysis, not consuming alcohol was observed to be the most favorable in terms of AF risk reduction (4). Larsson et al reported alcohol drinking, even in moderate quantity, to be a risk factor for incident AF, whereas Zhang et al observed moderate drinking to be associated with high AF risk in men only and not in females (5, 6). Moreover, a causal link between alcohol intake and other cardiovascular morbidities such as obesity, hypertension, left ventricular dysfunction and sleep apnea that are known risk factors for AF has been documented by several studies (1). Thus, we know that alcohol consumption, even in moderate quantity, increases the risk for AF, although may not be across genders. Observational studies also have shown unfavorable procedure outcome to be more common in drinkers compared to non-drinkers receiving AF ablation. However, there is no randomized data to support the latter statement. Additionally, there are no data on the influence of alcohol intake on the cognitive function and QoL in AF patients receiving catheter ablation. Therefore, this investigator-initiated, randomized trial has been designed to examine the impact of alcohol intake vs abstinence on arrhythmia recurrence and burden, QoL and cognitive function in regular drinkers undergoing their first catheter ablation.
  2. STUDY RATIONALE We hypothesize that alcohol-abstinence will significantly improve the procedural outcome, QoL and cognitive function in the study population compared to the non-abstinence cohort.
  3. STUDY OBJECTIVES Primary Objective Arrhythmia recurrence across all AF types at 8 months after the ablation procedure, off- or on-antiarrhythmic drug (AAD) Secondary Objective 1) Change in QoL score measured by AFEQT survey at baseline and 6 months 2) Change in cognitive function measured by MoCA survey 3) Arrhythmia burden at follow-up

Study period will start from the day after the procedure and continue for 8 months (2-month blanking period+ 6 months follow-up).

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

02

Conditions studied

  • Atrial Fibrillation

Keywords

  • Alcohol
  • AF
  • catheter ablation
  • recurrence
03

In context

Atrial Fibrillation

4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.

This study's planned enrollment of 184 is above the median of 150 across 2,476 interventional studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

Texas Cardiac Arrhythmia Research Foundation is the lead sponsor of 36 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion criteria

Exclusion Criteria:

  • Binge drinkers (alcohol dependence)
  • Non-drinkers
  • \<35%
  • Psychiatric conditions
  • 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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
184 participants (estimated)

Study arms

  • Active comparator
    Study

    Complete abstinence or ≤2 drinks/week in group 1 during the study period

    Behavioral: Study arm

  • Active comparator
    Control

    Allowed to continue their pre-ablation drinking habit

    Behavioral: Study arm

Interventions

  • BehavioralStudy arm

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

06

What researchers measure

Primary outcomes

  1. Arrhythmia recurrence

    Arrhythmia recurrence across all AF types at 8 months after the ablation procedure, off- or on-antiarrhythmic drug (AAD)

    Time frame: 8 months after the ablation procedure for AF

Secondary outcomes

  1. Change in QoL

    Change in QoL measured by AFEQT survey at baseline and 6 months

    Time frame: 6 months after the blanking period of 2 months

  2. Change in cognitive function

    Change in cognitive function measured by MoCA survey

    Time frame: 6 months after the blanking period of 2 months

  3. Arrhythmia burden

    Arrhythmia burden at follow-up

    Time frame: 6-8 months following ablation

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05510167
Lead sponsor
Texas Cardiac Arrhythmia Research Foundation
Responsible party
Andrea Natale (Executive Medical Director, Texas Cardiac Arrhythmia Research Foundation) — Principal investigator
First posted
Aug 22, 2022
Start date
Aug 22, 2022
Primary completion
Aug 2027 (estimated)
Completion
Aug 2027 (estimated)
Last update
Sep 14, 2026

Study contacts

Andrea Natale
Contact
dr.natale@gmail.com
5125448186
Sanghamitra Mohanty
Contact
mitra1989@gmail.com
5127842651
Andrea Natale
principal investigator · Texas Cardiac Arrhythmia Institute, St.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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