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

NCT06823778 | Recruiting FDA Device

• 1 other identifier: 1.2025
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Atrial Fibrillation

Keywords

Postoperative Atrial Fibrillation; Radiofrequency Ablation; Box Lesion Ablation; Prophylactic Ablation

Outcome Measures

Primary Outcomes (1)

• Postoperative Atrial Fibrillation

  Incidence of clinically significant (requiring any type of intervention) postoperative atrial fibrillation

  Within 30-day of surgery or until discharge, whichever came last, assessed up to 6 months after surgery

Secondary Outcomes (4)

• Postoperative Mortality

  Within 30-day of surgery or until discharge, whichever came last, assessed up to 6 months after surgery

• Postoperative Stroke

  Within 30-day of surgery or until discharge, whichever came last, assessed up to 6 months after surgery

• Length of Stay

  Up to 6 months after surgery

• Unplanned Readmission

  Within 30 days after surgery

Other Outcomes (4)

• Operative time

  Up to 24 hours after the start of the operation

• Cardiopulmonary bypass time

  Up to 24 hours after the start of the operation

• Cross-clamp time

  Up to 24 hours after the start of the operation

Study Arms (2)

Control

NO INTERVENTION

No ablation will be performed in this group of patients.

Intervention

EXPERIMENTAL

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

Device: Radiofrequency ablation

Interventions

Radiofrequency ablation 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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients undergoing cardiac surgery by a single surgeon (V.K.)
• Informed consent

You may not qualify if:

• History of atrial fibrillation/flutter
• Minimally invasive approach
• Off-pump surgery
• Emergent/salvage surgery
• Severe pericardial adhesions

Sponsors & Collaborators

• Vasily I. Kaleda: lead

Study Sites (1)

Department of Cardiac Surgery, Yudin Hospital

Moscow, Moscow, 115446, Russia

RECRUITING

Related Publications (2)

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Interventions

Radiofrequency Ablation

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Alexandr Piskun, M.D., Ph.D.

  Yudin Hospital

  STUDY CHAIR

Central Study Contacts

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

CONTACT

7 (985) 641 1769; vasily.kaleda@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A Prospective Parallel-Arm Single-Blind Randomized Trial

Study Record Dates

• First Submitted: February 2, 2025
• First Posted: February 12, 2025
• Study Start: February 17, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: February 21, 2025

Record last verified: 2025-02

Locations

RU (1)