Pharmacological Intervention to Prevent NOAF After TAVR

Starting soon · Not applicable

Conditions studied: Atrial Fibrillation

In brief

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

Key facts

Study ID

NCT07519161

Run by

Shanghai East Hospital

People needed

198

Starts

2026-04-07

Expected to finish

2030-03-31

Last updated by the study team

2026-04-15

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Post-TAVR (within 24 hours) Holter monitoring or continuous telemetry reveals either:
• ≥1,000 premature atrial contractions (PACs) per 24 hours; OR
• Episodes of atrial tachycardia lasting 3 to 30 seconds.
• Provided written informed consent.

You may not qualify if…

• 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).
• Undergoing any other concurrent cardiac surgical procedure.

Full record on ClinicalTrials.gov

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