BiodEgradable Soaked Amiodarone paTch Use for the Prevention of Atrial Fibrillation After Cardiac Surgery (BEAT-AF)

Jilin Heart Hospital

Status and phase: Enrolling; Phase 3

Conditions: Atrial Fibrillation (AF)

Treatments: Drug: topical amiodarone; Other: saline solution patch

Study type: Interventional

Funder types: Other

Identifiers

NCT06722196

Jilin Heart Hospital 2024

Details and patient eligibility

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

Enrollment: 500 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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500 participants in 2 patient groups

Experimental

Experimental group

Description:

patients will receive 2 patches soaked in cordarone hydrochloride (150 mg/3 ml each)

Sham

Sham Comparator group

Description:

patients will receive 2 patches soaked in saline solution (3 ml each)