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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-15

Study Completion Date

2027-12-15

Brief Summary

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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

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Detailed Description

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Conditions

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Atrial Fibrillation (AF)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Experimental

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

Group Type EXPERIMENTAL

No interventions assigned to this group

Sham

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

Group Type SHAM_COMPARATOR

No interventions assigned to this group

Interventions

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topical amiodarone

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

Intervention Type DRUG

saline solution patch

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

Intervention Type OTHER

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No