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BiodEgradable Soaked Amiodarone paTch Use for the Prevention of Atrial Fibrillation After Cardiac Surgery
RECRUITINGPhase 3Sponsored by Jilin Heart Hospital
Actively Recruiting
PhasePhase 3
SponsorJilin Heart Hospital
Started2025-02-15
Est. completion2027-01-15
Eligibility
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06722196
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
Healthy volunteers accepted
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
Conditions2
Atrial Fibrillation (AF)Heart Disease
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Actively Recruiting
PhasePhase 3
SponsorJilin Heart Hospital
Started2025-02-15
Est. completion2027-01-15
Eligibility
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06722196