BiodEgradable Soaked Amiodarone paTch Use for the Prevention of Atrial Fibrillation After Cardiac Surgery
Recruiting now · Phase 3
Conditions studied: Atrial Fibrillation (AF)
In brief
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
Key facts
- Study ID
- NCT06722196
- Run by
- Jilin Heart Hospital
- People needed
- 500
- Starts
- 2025-02-15
- Expected to finish
- 2027-12-15
- Last updated by the study team
- 2025-12-09
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Jilin Heart Hospital — Changchun, Jinlin, China (enrolling)
Full record on ClinicalTrials.gov
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