Pharmacological Intervention to Prevent NOAF After TAVR (NCT07519161) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Pharmacological Intervention to Prevent NOAF After TAVR
198 participantsStarted 2026-04-07
Plain-language summary
The goal of this clinical trial is to learn if amiodarone or metoprolol works to prevent new-onset atrial fibrillation (AF) in patients who develop certain atrial arrhythmias after transcatheter aortic valve replacement (TAVR). It will also learn about the safety of these drugs. The main questions it aims to answer are:
* Do amiodarone or metoprolol reduce the incidence of new-onset AF within 90 days after TAVR?
* What medical problems do participants have when taking amiodarone or metoprolol?
Researchers will compare amiodarone and metoprolol to observation (no antiarrhythmic drug) to see if either drug reduces the development of new-onset AF.
Participants who meet the post-TAVR arrhythmia criteria will:
* Be randomly assigned to receive amiodarone, metoprolol, or observation
* Take the assigned drug (if applicable) according to a specified dosing regimen
* Be monitored continuously during hospitalization and undergo follow-up assessments at 30, 60, and 90 days, including ECGs, Holter monitors, and laboratory tests
Who can participate
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Undergoing TAVR for symptomatic severe aortic stenosis (defined as aortic valve area \< 1.0 cm², mean gradient ≥ 40 mmHg, or peak jet velocity ≥ 4.0 m/s).
. Sinus rhythm confirmed by a 24-hour Holter monitor within 72 hours pre-TAVR.
. Known history of paroxysmal or persistent atrial fibrillation/flutter prior to TAVR.
. Presence of other significant arrhythmias pre-TAVR (e.g., \>1,000 premature ventricular contractions/24h, Mobitz Type I second-degree AV block or higher, sick sinus syndrome).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
New-Onset Atrial Fibrillation
Timeframe: Defined as any documented AF episode occurring within 90 days post-randomization.
. Current use of antiarrhythmic drugs (including beta-blockers, amiodarone, propafenone) prior to randomization.
. Concurrent participation in another investigational device or drug study that could confound results.
. Contraindications to amiodarone or metoprolol (e.g., severe bradycardia, cardiogenic shock, thyroid dysfunction, severe liver disease, QT prolongation).
. Undergoing any other concurrent cardiac surgical procedure.