Actively Recruiting

Phase 3
All Genders
NCT06722196

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

Led by Jilin Heart Hospital · Updated on 2025-12-09

500

Participants Needed

1

Research Sites

147 weeks

Total Duration

On this page

Sponsors

J

Jilin Heart Hospital

Lead Sponsor

C

Cornell University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients scheduled for elective cardiac surgery through complete sternotomy
  • Patients with coronary artery disease, aortic valve disease, mitral valve disease, tricuspid valve disease, or ascending aorta disease
  • Patients with these conditions either alone or in combination
Not Eligible

You will not qualify if you...

  • Patients with a history of atrial or ventricular arrhythmia of any type or duration
  • Patients undergoing repeat cardiac surgery
  • Patients requiring emergency surgery due to acute myocardial infarction or cardiogenic shock
  • Patients with thyroid dysfunction
  • Patients with hypertrophic obstructive cardiomyopathy (HOCM)
  • Patients with pacemakers or implantable cardioverter defibrillators (ICDs)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Jilin Heart Hospital

Changchun, Jinlin, China, 130000

Actively Recruiting

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Research Team

X

Xin Lu

CONTACT

S

Sui C Yu

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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