Prophylactic Radiofrequency Left Atrial Posterior Wall Isolation to Prevent Atrial Fibrillation After Cardiac Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Radiofrequency ablation.
- Who it may be relevant to
- Registry conditions: Postoperative Atrial Fibrillation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Russia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prophylactic Radiofrequency Left Atrial Posterior Wall Isolation (box Lesion Ablation) to Prevent Atrial Fibrillation After Cardiac Surgery (PROBOX): a Randomized Controlled Trial
Overview
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.
Interventions
- Device Radiofrequency ablation
In this group of patients, epicardial radiofrequency left atrial posterior wall isolation will be performed with AtriCure Isolator Synergy OLL2 bipolar radiofrequency clamp without opening the left atrium.
Primary outcome measures
- Postoperative Atrial Fibrillation [Time frame: Within 30-day of surgery or until discharge, whichever came last, assessed up to 6 months after surgery]
Secondary outcome measures (4)
- Postoperative Mortality [Time frame: Within 30-day of surgery or until discharge, whichever came last, assessed up to 6 months after surgery]
- Postoperative Stroke [Time frame: Within 30-day of surgery or until discharge, whichever came last, assessed up to 6 months after surgery]
- Length of Stay [Time frame: Up to 6 months after surgery]
- Unplanned Readmission [Time frame: Within 30 days after surgery]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
Russia · 1 center
- Department of Cardiac Surgery, Yudin Hospital — Moscow
Publications
- 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. PMID 39589863
- 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. PMID 39960384
Identifiers
NCT: NCT06823778 · 1.2025