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

Last updated: December 2, 2025
Sponsor: Jilin Heart Hospital
Overall Status: Active - Recruiting

Phase

3

Condition

Arrhythmia

Cardiac Disease

Dysrhythmia

Treatment

saline solution patch

topical amiodarone

Clinical Study ID

NCT06722196
Jilin Heart Hospital 2024
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 500
Treatment Group(s): 2
Primary Treatment: saline solution patch
Phase: 3
Study Start date:
February 15, 2025
Estimated Completion Date:
December 15, 2027

Connect with a study center

  • Jilin Heart Hospital

    Changchun 2038180, Jinlin 130000
    China

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.