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Pharmacological Intervention to Prevent NOAF After TAVR
Sponsor: Shanghai East Hospital
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
Official title: Pharmacological Intervention for Atrial Arrhythmias to Prevent New-Onset Atrial Fibrillation After Transcatheter Aortic Valve Replacement: A Prospective, Multicenter, Randomized Controlled Trial
Key Details
Gender
All
Age Range
Any - Any
Study Type
INTERVENTIONAL
Enrollment
198
Start Date
2026-04-07
Completion Date
2030-03-31
Last Updated
2026-04-09
Healthy Volunteers
No
Conditions
Interventions
Metoprolol succinate
Start: Metoprolol succinate 47.5 mg once daily (QD). Titration: Dose adjusted every 48 hours to achieve a target resting heart rate of 60-80 bpm.
Amiodarone
Loading: 200 mg three times daily (TID) until a cumulative dose of 3g is reached. Maintenance: 200 mg QD thereafter.