Using radiofrequency ablation to prevent atrial fibrillation after heart surgery
Prophylactic Radiofrequency Left Atrial Posterior Wall Isolation (box Lesion Ablation) to Prevent Atrial Fibrillation After Cardiac Surgery (PROBOX): a Randomized Controlled Trial
This study is testing if a special heart procedure can help prevent new cases of atrial fibrillation in patients after they have heart surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 216 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Yudin Hospital Academic / other |
| Locations | 1 site (Moscow, Moscow) |
| Trial ID | NCT06823778 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates whether epicardial radiofrequency left atrial posterior wall isolation, also known as box lesion ablation, can effectively prevent postoperative atrial fibrillation (POAF) in patients undergoing cardiac surgery. Participants will be randomly assigned to receive either the ablation procedure or no ablation during their cardiac surgery. The study aims to determine if this approach reduces the incidence of de-novo atrial fibrillation requiring treatment after surgery. Data will be collected during the hospital stay and followed up with participants 30 days post-surgery to assess outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are patients scheduled for cardiac surgery who can provide informed consent.
Not a fit: Patients with a history of atrial fibrillation or those undergoing minimally invasive or emergency surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the occurrence of atrial fibrillation after cardiac surgery, leading to better patient outcomes and shorter hospital stays.
How similar studies have performed: Previous studies have explored radiofrequency ablation for atrial fibrillation but have faced limitations; this study aims to provide a more robust evaluation of a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All patients undergoing cardiac surgery by a single surgeon (V.K.) * Informed consent Exclusion Criteria: * History of atrial fibrillation/flutter * Minimally invasive approach * Off-pump surgery * Emergent/salvage surgery * Severe pericardial adhesions
Where this trial is running
Moscow, Moscow
- Department of Cardiac Surgery, Yudin Hospital — Moscow, Moscow, Russia (Recruiting)
Study contacts
- Study coordinator: Vasily I. Kaleda, M.D., Ph.D.
- Email: vasily.kaleda@gmail.com
- Phone: 7 (985) 641 1769
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.