An interventional study of Radiofrequency ablation in Postoperative Atrial Fibrillation, sponsored by Vasily I. Kaleda. Recruiting at 1 site in Russian Federation. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-21.
Sponsored by Vasily I. Kaleda · Not applicable, Interventional, and Prevention
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:
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.
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.
4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.
This study's planned enrollment of 216 is above the median of 150 across 2,476 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →This is the only study on the registry with Vasily I. Kaleda as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
No ablation will be performed in this group of patients.
In this group of patients, radiofrequency left atrial posterior wall isolation will be performed.
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.
Postoperative Atrial Fibrillation
Incidence of clinically significant (requiring any type of intervention) postoperative atrial fibrillation
Time frame: Within 30-day of surgery or until discharge, whichever came last, assessed up to 6 months after surgery
Postoperative Mortality
All deaths occurring during the hospitalization in which the operation was performed, even if after 30 days; and all deaths occurring after discharge from the hospital, but before the end of the 30th postoperative day.
Time frame: Within 30-day of surgery or until discharge, whichever came last, assessed up to 6 months after surgery
Postoperative Stroke
Number of patients who have a postoperative stroke (i.e., any confirmed neurological deficit of abrupt onset caused by a disturbance in blood supply to the brain) that did not resolve within 24 hours
Time frame: Within 30-day of surgery or until discharge, whichever came last, assessed up to 6 months after surgery
Length of Stay
Postoperative length of in-hospital stay
Time frame: Up to 6 months after surgery
Unplanned Readmission
Unplanned 30-day any cause readmission rate
Time frame: Within 30 days after surgery
Operative time
Total operative time (min)
Time frame: Up to 24 hours after the start of the operation
Cardiopulmonary bypass time
Total cardiopulmonary bypass time (min)
Time frame: Up to 24 hours after the start of the operation
Cross-clamp time
Total cross-clamp time (min)
Time frame: Up to 24 hours after the start of the operation
Other arrhythmias rate
Any arrhytmias other than POAF rate
Time frame: Within 30-day of surgery or until discharge, whichever came last, assessed up to 6 months after surgery
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.