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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorTexas Cardiac Arrhythmia Research Foundation

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Binge drinkers (alcohol dependence)

Non-drinkers

LVEF <35%

Psychiatric conditions

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

184 Participants
are divided into 2 treatment groups
Group A: StudyActive comparator 1 intervention
Group B: ControlActive comparator 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

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