NCT07519161Not yet recruiting
Pharmacological Intervention to Prevent NOAF After TAVR
Pharmacological Intervention for Atrial Arrhythmias to Prevent New-Onset Atrial Fibrillation After Transcatheter Aortic Valve Replacement: A Prospective, Multicenter, Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 15 Apr 2026
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 198 (estimated)
- First submitted
- 1 Apr 2026
- Start date
- 7 Apr 2026
- Primary completion date
- 31 Dec 2029
- Lead sponsor
- Shanghai East Hospital
- Diseases
- Atrial fibrillation
- NCT number
- NCT07519161
What you commit to
- Study type: Interventional
- Planned participants: 198
- From 7 Apr 2026 to the primary completion date, 31 Dec 2029
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Known history of paroxysmal or persistent atrial fibrillation/flutter prior to TAVR.
- 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.
- Undergoing any other concurrent cardiac surgical procedure.
Other illness
- 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).
Lab values
- Contraindications to amiodarone or metoprolol (e.g., severe bradycardia, cardiogenic shock, thyroid dysfunction, severe liver disease, QT prolongation).
Who the study is looking for
- 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.
Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.