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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Metoprolol succinate

    Drug

    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

    Drug

    Loading: 200 mg three times daily (TID) until a cumulative dose of 3g is reached. Maintenance: 200 mg QD thereafter.

Treatment groups

198 Participants
are divided into 3 treatment groups
Group A: ControlNo intervention 0 interventions
Group B: MetoprololExperimental treatment 1 intervention
Group C: AmiodaroneExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

New-Onset Atrial Fibrillation

Time frame
Defined as any documented AF episode occurring within 90 days post-randomization.

Secondary outcomes

1

Freedom from Atrial Arrhythmias

Time frame
90 days
2

Safety Endpoint

Incidence of high-degree atrioventricular block (HD-AVB) or permanent pacemaker (PPM) implantation

Time frame
90 days
3

Clinical Efficacy Endpoint

All-cause mortality, stroke, or cardiovascular-related rehospitalization

Time frame
90 days
4

Drug Tolerability

Rate of permanent drug discontinuation due to adverse effects

Time frame
90 days

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai East Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: