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

Phase 3

Not yet recruiting

• Conditions: Atrial Fibrillation (AF)
• Interventions: Drug: topical amiodarone; Other: saline solution patch

• Registration Number: NCT06722196
• Lead Sponsor: Jilin Heart Hospital

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-12-05
• Study First Submitted QC: 2024-12-05
• Last Update Submitted: 2024-12-05
• Study First Posted: 2024-12-09
• Last Update Posted: 2024-12-09
• Study Start: 2025-01-15
• Primary Completion: 2027-01-15
• Study Completion: 2027-12-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	topical amiodarone	patients will receive 2 patches soaked in cordarone hydrochloride (150 mg/3 ml each)
Sham	saline solution patch	patients will receive 2 patches soaked in saline solution (3 ml each)

Primary Outcome Measures

Name	Time	Method
postoperative atrial fibrillation versus control	within 5 days after surgery	incidence of in-hospital atrial fibrillation