NCT05510167

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P50-P75 for not_applicable atrial-fibrillation

Timeline
Completed

Started Aug 2022

Typical duration for not_applicable atrial-fibrillation

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 15, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 22, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

August 22, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

August 22, 2022

Status Verified

August 1, 2022

Enrollment Period

1.9 years

First QC Date

August 15, 2022

Last Update Submit

August 18, 2022

Conditions

Atrial Fibrillation

Keywords

AlcoholAFcatheter ablationrecurrence

Outcome Measures

Primary Outcomes (1)

  • Arrhythmia recurrence

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

    8 months after the ablation procedure for AF

Secondary Outcomes (3)

  • Change in QoL

    6 months after the blanking period of 2 months

  • Change in cognitive function

    6 months after the blanking period of 2 months

  • Arrhythmia burden

    6-8 months following ablation

Study Arms (2)

Study

ACTIVE COMPARATOR

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

Behavioral: Study arm

Control

ACTIVE COMPARATOR

Allowed to continue their pre-ablation drinking habit

Behavioral: Study arm

Interventions

Study armBEHAVIORAL

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

ControlStudy

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You 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 may not qualify 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Atrial FibrillationRecurrence

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsDisease Attributes

Study Officials

  • Andrea Natale

    Texas Cardiac Arrhythmia Institute, St.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Natale

CONTACT

5125448186dr.natale@gmail.com

Sanghamitra Mohanty

CONTACT

5127842651mitra1989@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Paroxysmal and Persistent AF patients undergoing their first catheter ablation will be screened for eligibility and those that meet the criteria and consent to participate will be randomly assigned to group 1 or 2. 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Executive Medical Director

Study Record Dates

First Submitted

August 15, 2022

First Posted

August 22, 2022

Study Start

August 22, 2022

Primary Completion

August 1, 2024

Study Completion

August 1, 2025

Last Updated

August 22, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share