Pharmacological Intervention to Prevent NOAF After TAVR
ConditionAtrial Fibrillation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorShanghai East Hospital
About this trial
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
Eligibility criteria
Qualifiers
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.
≥1,000 premature atrial contractions (PACs) per 24 hours; OR
Episodes of atrial tachycardia lasting 3 to 30 seconds.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Metoprolol succinate
- Amiodarone
Treatment groups
198 Participants
are divided into 3 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov