drugset / Trial / NCT07519161

Pharmacological Intervention to Prevent NOAF After TAVR

NCT07519161

Not yet recruiting 198 enrolled Shanghai East Hospital
RandomizedParallel-groupSingle-blindTreatment

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

Timeline

Start
2026-04-07
Primary completion
2029-12-31
Completion
2030-03-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Amiodarone Small molecule 200 mg
Subject Metoprolol Other / unclassified 47.5 mg

Indications