Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06722196

BiodEgradable Soaked Amiodarone paTch Use for the Prevention of Atrial Fibrillation After Cardiac Surgery

The primary objective of the present prospective, randomized, double blind, controlled study is to assess whether the application of 2 oxidized regenerated cellulose (SurgicelTM FibrillarTM) patches soaked with amiodarone hydrochloride over the anterior wall of the left atrium and the lateral wall of the right atrium results in a reduction in the incidence of POAF

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Atrial Fibrillation (AF) Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Jilin Heart Hospital

Changchun, Jinlin, 130000, China

Location status: Recruiting

Location contact

Xinlu MD, Medicine

CONTACT

[email protected]

13630550989

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients who are candidates for elective cardiac surgery trough complete sternotomy with indications of coronary artery disease (both off-pump and on-pump), aortic valve disease, mitral valve disease, tricuspid valve disease, and ascending aorta disease, whether as an isolated pathology or in combination

Exclusion criteria

  • patients with a clinical history of atrial or ventricular arrhythmia of any nature and duration, patients undergoing reoperation, patients with emergency surgical indications due to acute myocardial infarction or cardiogenic shock, patients with thyroid disfunction, patients with HOCM and those with pacemakers or ICDs

Treatment and study plan

topical amiodarone

Drug

amiodarone soaked patch placed on the left atrial roof at the end of surgery

saline solution patch

Other

saline solution soaked patch placed on left atrial roof at the end of surgery

Primary outcomes

  1. postoperative atrial fibrillation versus control

    Time frame: within 5 days after surgery

    incidence of in-hospital atrial fibrillation

Study contacts

Contact information is provided by the study sponsor or research team.

Sui C Yu

CONTACT

[email protected]

+86 17304316969

Xin Lu

CONTACT

[email protected]

+86 13630550809

Sponsors and collaborators

Lead sponsor

Jilin Heart Hospital

Other

Collaborators

  • Cornell University

Registry information

Acronym: BEAT-AF

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 9, 2024
Registry last updated
Dec 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.