Biodegradable amiodarone patches placed on the heart to prevent atrial fibrillation after open-heart surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Pulsed Field vs Cryoballoon for Pulmonary Vein Isolation in Atrial Fibrillation

  This trial tests whether pulsed field ablation can shorten the procedure for first-time PVI in AF patients compared with cryoballoon ablation, while keeping safety and effectiveness similar.

  Recruiting St. Josefs-Hospital Wiesbaden GmbH · Wiesbaden · NCT07910370

• Pulsed Field Ablation vs Cryoablation for Atrial Fibrillation Under Deep Sedation

  This trial tests whether pulsed field ablation (PFA) done under deep sedation works as well as cryoballoon ablation for treating atrial fibrillation, aiming to avoid general anesthesia.

  Recruiting East Sussex Healthcare NHS Trust · Eastbourne · NCT07900685

• Bachmann’s Bundle Pacing vs Right Atrial Appendage Pacing for AF

  This study tests two common atrial pacing methods to see which one is safer over 12 months for people getting a new pacemaker, ICD, or CRT device.

  Recruiting Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) · Pittsburgh, Pennsylvania · NCT07874763

• AI-powered ECG to help diagnose and predict outcomes in heart disease

  Researchers test an AI-enhanced ECG to help diagnose and predict outcomes for people with cardiovascular diseases.

  Recruiting Inha University Hospital · Incheon, Incheon · NCT07856472

• Pace-and-ablate strategy in atrial fibrillation: who benefits and long-term outcomes

  This study looks at adults with atrial fibrillation who underwent AV node ablation with permanent pacing to see who develops pacing-induced problems and how they do long-term.

  Recruiting at 5 sites Insel Gruppe AG, University Hospital Bern · Zabrze and 4 other locations · NCT07852221

• AI-based cardiac analysis using 12-lead and 1-lead ECG

  A clinician-facing pilot test to see if SmartECG-EF helps evaluate heart function using both 12-lead and single-lead ECGs in adults with heart conditions.

  Recruiting Inha University Hospital · Incheon, Incheon · NCT07844434

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.