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

NCT ID: NCT06823778

Last Updated: 2025-02-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 216 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-17
• Study Completion Date: 2027-09-30

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.

Conditions

Postoperative Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Control

No ablation will be performed in this group of patients.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention

In this group of patients, radiofrequency left atrial posterior wall isolation will be performed.

Group Type: EXPERIMENTAL

Radiofrequency ablation

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vasily I. Kaleda

OTHER

Sponsor Role: lead

Responsible Party

Vasily I. Kaleda

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Alexandr Piskun, M.D., Ph.D.

Role: STUDY_CHAIR

Yudin Hospital

Locations

Department of Cardiac Surgery, Yudin Hospital

Moscow, Moscow, Russia

Site Status: RECRUITING

Countries

Russia

Central Contacts

Vasily I. Kaleda, M.D., Ph.D.

Role: CONTACT

vasily.kaleda@gmail.com

7 (985) 641 1769

Facility Contacts

Vasily I. Kaleda, M.D., Ph.D.

Role: primary

vasily.kaleda@gmail.com

7 (985) 641 1769

References

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.

Reference Type: BACKGROUND

PMID: 39589863 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 39960384 (View on PubMed)

Other Identifiers

1.2025

Identifier Type: -

Identifier Source: org_study_id