Atrial Fibrillation (AF)
Conditions
Brief 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
Interventions
DRUGtopical amiodarone
amiodarone soaked patch placed on the left atrial roof at the end of surgery
OTHERsaline solution patch
saline solution soaked patch placed on left atrial roof at the end of surgery
Sponsors
Cornell University
Jilin Heart Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| postoperative atrial fibrillation versus control | within 5 days after surgery | incidence of in-hospital atrial fibrillation |
Countries
China
Contacts
Primary ContactXin Lu
Backup ContactSui C Yu
Outcome results
None listed