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Heart drug after ablation: did it prevent AFib return?

NCT ID NCT04704050

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether the drug dronedarone could prevent atrial fibrillation (AFib) from coming back after a heart ablation procedure. About 22 adults with AFib who had ablation were randomly given either dronedarone or a placebo. The goal was to see if the drug reduced irregular heartbeats and scarring in the heart. The study was stopped early, so results are limited.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

22 people

The number who actually took part.

Started

May 2021

Finished

Dec 2022

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Patients must meet the following criteria to be enrolled in the trial. * Male or female patients aged over 18 years of age. * Patients with paroxysmal or persistent atrial fibrillation who are undergoing ablation of atrial fibrillation, regardless of whether they were receiving an anti-arrhythmic drug (AADs) before enrollment or not. Exclusion Criteria: Patients will be excluded from enrollment if any of the following criteria are present. * Any health-related gadolinium/MRI contraindications (e.g. allergy to gadolinium, pacemakers, Implantable Cardioverter Defibrillators \[ICD's\], other devices/implants contraindicated for use of MRI, etc.). * Patients weighing \>300 Ibs. (MRI quality decreases as BMI increases). * Patients with contraindications to dronedarone. (Including patients with decompensated heart failure or class NYHA IV (New York Heart Association Class IV), second or third-degree atrioventricular (AV) block or sick-sinus syndrome \[except when used in conjunction with a functioning pacemaker\]), concomitant use of strong cytochrome P450, family 3, subfamily A (CYP-3A) inhibitors or other Class I or III AADs, drug or herbal products that prolongs the QT interval and may induce Torsades de Pointes. * Liver or lung toxicity related to the previous use of amiodarone, severe hepatic impairment including any stage of cirrhosis and acute liver failure, bradycardia \<50bpm, QTc Bazett interval \>500ms or PR interval \>280ms, or hypersensitivity to the active substance or to any of its excipients. * Acute or chronic severe renal disease with a low glomerular filtration rate (GFR), \<30 mL per minute per 1.73m2 will be excluded from the trial. * Patients with a history of prior left atrial ablation or valvular cardiac surgery (myocardial scarring/fibrosis from prior surgeries may confound data). * Pre-menopausal (last menstruation \<1 year prior to screening) who: 1. are pregnant or breast-feeding or plan to become pregnant during the study period or, 2. are not surgically sterile or, 3. are of childbearing potential and not practising two acceptable methods of birth control or, 4. do not plan to continue practising two acceptable methods of birth control throughout the trial (highly effective methods of birth control are defined as those, used alone, or in combination, that result in a low failure rate i.e. less than 1% per year when used consistently and correctly). * Patients who do not have access to the Internet/e-mail. * Patients without daily access to a smart phone-compatible with ECG Check device application and ability to upload ECG tracings for the entire follow-up period. * Patients unable or unwilling to return to the clinic for follow up CMR scans. * Patients with cognitive impairments who are unable to give informed consent.

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Conditions

The condition(s) this trial relates to.

Arrhythmias, Cardiac atrial fibrillation Heart Murmurs

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Baylor College of Medicine

    Houston, Texas, 77030, United States

  • Emory University

    Atlanta, Georgia, 30322, United States

  • Tulane University School of Medicine

    New Orleans, Louisiana, 70112, United States

  • University of Colorado Health Memorial

    Colorado Springs, Colorado, 80909, United States

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