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Pharmacological Intervention to Prevent NOAF After TAVR

NCT07519161 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 198

Last updated 2026-04-15

No results posted yet for this study

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

Conditions

Interventions

DRUG

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.

DRUG

Amiodarone

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

Sponsors & Collaborators

  • Shanghai East Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07519161 on ClinicalTrials.gov