Preventing Atrial Fibrillation After Heart Surgery with Amiodarone
Assessment of Intra-Operative Atrial Fibrillation Inducibility As a Screening Tool to Prevent Post-Operative Atrial Fibrillation With Prophylaxis Amiodarone
This study is testing if giving amiodarone before heart surgery can help prevent atrial fibrillation in patients who are at risk for it.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Stanford University Academic / other |
| Locations | 1 site (Stanford, California) |
| Trial ID | NCT03868150 on ClinicalTrials.gov |
What this trial studies
This study investigates the prevention of postoperative atrial fibrillation (POAF) in patients undergoing first-time cardiac surgery. Prior to cardiopulmonary bypass, patients will undergo rapid atrial pacing to assess their heart's susceptibility to atrial fibrillation. Those who show inducible atrial fibrillation will be randomly assigned to receive either prophylactic amiodarone treatment or no treatment, while those who do not show inducibility will receive standard postoperative care. The study aims to evaluate the effectiveness of this approach in reducing the incidence of POAF.
Who should consider this trial
Good fit: Ideal candidates are patients scheduled for first-time non-emergent open-heart surgery with normal sinus rhythm and no history of atrial fibrillation.
Not a fit: Patients with a prior history of atrial fibrillation or those requiring surgical treatment for atrial arrhythmias will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the occurrence of postoperative atrial fibrillation, improving recovery and outcomes for cardiac surgery patients.
How similar studies have performed: Other studies have explored similar preventive measures for postoperative atrial fibrillation, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients scheduled for first-time non-emergent open-heart surgery for coronary artery bypass graft (CABG) revascularization, valvular repair or replacement, combined CABG with valve repair or replacement, or valve sparing aortic root repair * Normal sinus rhythm * No documented history of atrial fibrillation Exclusion Criteria: * Prior surgical procedures involving heart surgery and cardiopulmonary bypass * Any prior documented history of atrial fibrillation, atrial flutter or atrial tachycardia lasting longer than 30 seconds * Prior history of Amiodarone treatment for the management of supraventricular tachy-arrhythmias * Patients requiring surgical treatment of atrial arrhythmias such as pulmonary vein isolation or Maze procedure.
Where this trial is running
Stanford, California
- Stanford University — Stanford, California, United States (Recruiting)
Study contacts
- Principal investigator: Anson Lee, MD — Stanford University
- Study coordinator: Anson Lee, MD
- Email: ansonlee@stanford.edu
- Phone: 650-724-7500
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.