RecruitingPhase 3NCT06722196

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


Sponsor

Jilin Heart Hospital

Enrollment

500 participants

Start Date

Feb 15, 2025

Study Type

INTERVENTIONAL

Conditions

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

Plain Language Summary

Simplified for easier understanding

This study is testing a biodegradable patch soaked in amiodarone — a heart rhythm medication — that is placed directly on the heart during cardiac surgery to prevent atrial fibrillation (an irregular heartbeat) that often occurs after surgery. Currently, amiodarone is given through a vein (IV), which can cause side effects; this local delivery method may be safer. **You may be eligible if...** - You are scheduled for planned (non-emergency) open-heart surgery through a full sternotomy (chest opening) - Your surgery is for conditions such as coronary artery disease, aortic valve disease, mitral valve disease, tricuspid valve disease, or aortic aneurysm — or any combination of these **You may NOT be eligible if...** - You have a history of any heart rhythm disorder (atrial or ventricular arrhythmia) - You are having a repeat (redo) open-heart surgery - You are having emergency surgery due to heart attack or cardiogenic shock - You have a thyroid disorder - You have a specific heart muscle condition called hypertrophic obstructive cardiomyopathy (HOCM) - You have a pacemaker or an implantable defibrillator Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGtopical amiodarone

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

OTHERsaline solution patch

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


Locations(1)

Jilin Heart Hospital

Changchun, Jinlin, China

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NCT06722196


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