Clinical trial NCT06823778: Prophylactic Radiofrequency Left Atrial Posterior Wall Isolation to Prevent Atrial Fibrillation After Cardiac Surgery
Official title: Prophylactic Radiofrequency Left Atrial Posterior Wall Isolation (box Lesion Ablation) to Prevent Atrial Fibrillation After Cardiac Surgery (PROBOX): a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postoperative Atrial Fibrillation
Keywords: Postoperative Atrial Fibrillation
Radiofrequency Ablation
Box Lesion Ablation
Prophylactic Ablation
Lead sponsor: Yudin Hospital
Sponsor class: OTHER
First posted: 2025-02-12
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Prospective Parallel-Arm Single-Blind Randomized Trial
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to learn if an epicardial radiofrequency left atrial posterior wall isolation (box lesion ablation) prevents atrial fibrillation after cardiac surgery. The main question it aims to answer is:

- Does box lesion ablation lower the number of patients experiencing de-novo atrial fibrillation requiring any treatment after cardiac surgery? Researchers will compare box lesion ablation to no ablation to see if ablation prevents postoperative atrial fibrillation.

Participants will undergo ablation or no ablation at the time of other cardiac surgery.

Data will be collected while in hospital. Additional information will be collected on 30th day after surgery by telephone call or during a visit.

Detailed description: Postoperative atrial fibrillation (POAF) is a common complication after heart surgery that occurs in 10-60% of patients. It can cause hypotension, tachycardia, stroke, systemic embolism, or heart failure, and is associated with increased mortality rates, prolonged hospital stays and increased costs. Several studies have investigated the use of radiofrequency ablation (the standard of surgical care for atrial fibrillation during concomitant cardiac surgery when the diagnosis is known preoperatively) to prevent POAF. However, these studies were limited mainly to pulmonary vein isolation and had methodological limitations such as small sample sizes, inclusion/exclusion criteria, and randomization procedures, and have not translated into clinical practice changes. The current study aims to investigate the use of radiofrequency left atrial posterior wall isolation, also known as box lesion ablation, as a more effective treatment compared to pulmonary vein isolation, in a properly designed randomized controlled trial.

Eligibility 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

Primary outcomes:
measure: Postoperative Atrial Fibrillation
timeFrame: Within 30-day of surgery or until discharge, whichever came last, assessed up to 6 months after surgery
Secondary outcomes:
measure: Postoperative Mortality
timeFrame: Within 30-day of surgery or until discharge, whichever came last, assessed up to 6 months after surgery
measure: Postoperative Stroke
timeFrame: Within 30-day of surgery or until discharge, whichever came last, assessed up to 6 months after surgery
measure: Length of Stay
timeFrame: Up to 6 months after surgery
measure: Unplanned Readmission
timeFrame: Within 30 days after surgery
Other outcomes:
measure: Operative time
timeFrame: Up to 24 hours after the start of the operation
measure: Cardiopulmonary bypass time
timeFrame: Up to 24 hours after the start of the operation
measure: Cross-clamp time
timeFrame: Up to 24 hours after the start of the operation
measure: Other arrhythmias rate
timeFrame: Within 30-day of surgery or until discharge, whichever came last, assessed up to 6 months after surgery
Locations:
city: Moscow
country: Russian Federation
facility: Department of Cardiac Surgery, Yudin Hospital
Study officials:
affiliation: Yudin Hospital
name: Alexandr Piskun, M.D., Ph.D.
role: STUDY_CHAIR
References:
citation: Visanji M, Belley-Cote EP, Pandey A, Amit Y, McClure GR, Young J, Um KJ, Oraii A, Healey JS, Whitlock RP, McIntyre WF. Prophylactic ablation during cardiac surgery in patients without atrial fibrillation: a systematic review and meta-analysis of randomized trials. Interdiscip Cardiovasc Thorac Surg. 2024 Dec 3;39(6):ivae195. doi: 10.1093/icvts/ivae195.
citation: Kaleda VI, Snegirev MA, Efendiev VU, Piskun AV, Batukov IA, Nazaryan KE, Pidanov OY. Concomitant Box Lesion Ablation for Atrial Fibrillation with a Standard Non-Irrigated Bipolar Radiofrequency Clamp: Simplified Approach Without Left Atriotomy. Braz J Cardiovasc Surg. 2025 Feb 17;40(2):e20230432. doi: 10.21470/1678-9741-2023-0432.