NCT07519161

Brief 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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
198

participants targeted

Target at P50-P75 for not_applicable atrial-fibrillation

Timeline
46mo left

Started Apr 2026

Typical duration for not_applicable atrial-fibrillation

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress5%
Apr 2026Mar 2030

First Submitted

Initial submission to the registry

April 1, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

April 7, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 9, 2026

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2029

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2030

Last Updated

April 15, 2026

Status Verified

February 1, 2026

Enrollment Period

3.7 years

First QC Date

April 1, 2026

Last Update Submit

April 10, 2026

Conditions

Atrial Fibrillation

Keywords

Transcatheter aortic valve replacementNew-onset atrial fibrillationAtrial tachycardiaMetoprololAmiodaroneRandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • New-Onset Atrial Fibrillation

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

Secondary Outcomes (4)

  • Freedom from Atrial Arrhythmias

    90 days

  • Safety Endpoint

    90 days

  • Clinical Efficacy Endpoint

    90 days

  • Drug Tolerability

    90 days

Study Arms (3)

Control

NO INTERVENTION

No antiarrhythmic drug initiated

Metoprolol

EXPERIMENTAL

Metoprolol succinate 47.5 mg once daily.Dose adjusted every 48 hours to achieve a target resting heart rate of 60-80 bpm.

Drug: Metoprolol succinate

Amiodarone

EXPERIMENTAL

200 mg three times daily until a cumulative dose of 3g is reached. Then 200 mg QD thereafter.

Drug: Amiodarone

Interventions

Metoprolol succinateDRUG

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.

Metoprolol
AmiodaroneDRUG

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

Amiodarone

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • Contraindications to amiodarone or metoprolol (e.g., severe bradycardia, cardiogenic shock, thyroid dysfunction, severe liver disease, QT prolongation).
  • Undergoing any other concurrent cardiac surgical procedure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

MetoprololAmiodarone

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesBenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Central Study Contacts

Hongxiao Li, doctor

CONTACT

86-19145711959lhxlmt@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2026

First Posted

April 9, 2026

Study Start

April 7, 2026

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

March 31, 2030

Last Updated

April 15, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share