Biodegradable amiodarone patches placed on the heart to prevent atrial fibrillation after open-heart surgery
BiodEgradable Soaked Amiodarone paTch Use for the Prevention of Atrial Fibrillation After Cardiac Surgery
This trial will try placing biodegradable patches soaked with amiodarone on the outside of the atria during open-heart surgery to see if it reduces new atrial fibrillation after elective cardiac operations.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Sex | All |
| Sponsor | Jilin Heart Hospital Academic / other |
| Locations | 1 site (Changchun, Jinlin) |
| Trial ID | NCT06722196 on ClinicalTrials.gov |
What this trial studies
This randomized, double-blind, controlled Phase 3 trial compares two oxidized regenerated cellulose patches soaked with amiodarone versus saline applied over the anterior left atrium and lateral right atrium at the end of elective full-sternotomy cardiac surgery. Eligible procedures include coronary artery bypass, aortic, mitral, tricuspid, and ascending aorta operations performed on- or off-pump, while patients with prior atrial or ventricular arrhythmias, reoperations, emergency indications, pacemakers/ICDs, thyroid dysfunction, or HOCM are excluded. The primary outcome is the incidence of postoperative atrial fibrillation (POAF), with blinded outcome assessment and standard postoperative monitoring. The intervention aims to deliver local antiarrhythmic therapy to the atrial surface with limited systemic exposure compared with systemic drug dosing.
Who should consider this trial
Good fit: Adults scheduled for elective full-sternotomy cardiac surgery (coronary, valve, or ascending aorta procedures) who do not have a prior history of atrial or ventricular arrhythmia and who do not have pacemakers/ICDs, thyroid dysfunction, HOCM, or emergency/reoperative indications.
Not a fit: Patients with prior atrial or ventricular arrhythmias, those undergoing reoperation or emergency surgery, and those with pacemakers/ICDs, thyroid dysfunction, or HOCM are unlikely to qualify and are not expected to benefit from this intervention.
Why it matters
Potential benefit: If successful, this approach could lower rates of postoperative atrial fibrillation, reducing complications and potentially shortening hospital stays.
How similar studies have performed: Smaller clinical and experimental studies of topical or epicardial amiodarone have shown mixed but often encouraging reductions in POAF, while large-scale phase 3 evidence for soaked biodegradable patches remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Changchun, Jinlin
- Jilin Heart Hospital — Changchun, Jinlin, China (Recruiting)
Study contacts
- Principal investigator: Massimo G Lemma, PhD — Jilin Heart Hospital
- Study coordinator: Xin Lu
- Email: xin.lu@jlheart.org
- Phone: +86 13630550809
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.