Tests an amiodarone-soaked patch to prevent atrial fibrillation after heart surgery
Tests a drug-soaked patch placed on the heart during surgery, compared with a saline patch.
Plain-language title generated from the registry record
Registry title: BiodEgradable Soaked Amiodarone paTch Use for the Prevention of Atrial Fibrillation After Cardiac Surgery
Key facts
- Where
- Changchun, ChinaSee the site
- Phase
- Phase 3
Where in China
- Jilin Heart HospitalChangchun, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Jilin Heart Hospital
- Trial code
- NCT06722196
- Record updated
- 9 December 2025
- Original description
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 POAFRead full original descriptionShow less
BiodEgradable Soaked Amiodarone paTch Use for the Prevention of Atrial Fibrillation After Cardiac Surgery
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
Inclusion: 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: 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.