Prophylactic Radiofrequency Left Atrial Posterior Wall Isolation to Prevent Atrial Fibrillation After Cardiac Surgery

Not Applicable

Recruiting

• Conditions: Postoperative Atrial Fibrillation

• Registration Number: NCT06823778
• Lead Sponsor: Vasily I. Kaleda

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.

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-02
• Study First Submitted QC: 2025-02-06
• Study First Posted: 2025-02-12
• Study Start: 2025-02-17
• Last Update Submitted: 2025-02-19
• Last Update Posted: 2025-02-21
• Primary Completion: 2027-09
• Study Completion: 2027-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 216

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Postoperative Atrial Fibrillation	Within 30-day of surgery or until discharge, whichever came last, assessed up to 6 months after surgery	Incidence of clinically significant (requiring any type of intervention) postoperative atrial fibrillation

Secondary Outcome Measures

Name	Time	Method
Postoperative Mortality	Within 30-day of surgery or until discharge, whichever came last, assessed up to 6 months after surgery	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.
Postoperative Stroke	Within 30-day of surgery or until discharge, whichever came last, assessed up to 6 months after surgery	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
Length of Stay	Up to 6 months after surgery	Postoperative length of in-hospital stay
Unplanned Readmission	Within 30 days after surgery	Unplanned 30-day any cause readmission rate

Trial Locations

Locations (1)

Department of Cardiac Surgery, Yudin Hospital; 🇷🇺 Moscow, Russian Federation