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
SexALL
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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).
✕. 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).
What they're measuring
1
New-Onset Atrial Fibrillation
Timeframe: Defined as any documented AF episode occurring within 90 days post-randomization.