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Recruiting Phase 3 NCT06722196

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

Trial Parameters

Condition Atrial Fibrillation (AF)
Sponsor Jilin Heart Hospital
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 500
Sex ALL
Min Age N/A
Max Age N/A
Start Date 2025-02-15
Completion 2027-01-15
Interventions
topical amiodaronesaline solution patch

Brief 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 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

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