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

February 19, 2025 updated by: Vasily I. Kaleda

Prophylactic Radiofrequency Left Atrial Posterior Wall Isolation (box Lesion Ablation) to Prevent Atrial Fibrillation After Cardiac Surgery (PROBOX): a Randomized Controlled Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

216

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Russian Federation
      • Moscow, Russian Federation, 115446
        • Recruiting
        • Department of Cardiac Surgery, Yudin Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
No ablation will be performed in this group of patients.
Experimental: Intervention
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Atrial Fibrillation
Time Frame: 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
Within 30-day of surgery or until discharge, whichever came last, assessed up to 6 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Mortality
Time Frame: 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.
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
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
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
Postoperative length of in-hospital stay
Up to 6 months after surgery
Unplanned Readmission
Time Frame: Within 30 days after surgery
Unplanned 30-day any cause readmission rate
Within 30 days after surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operative time
Time Frame: Up to 24 hours after the start of the operation
Total operative time (min)
Up to 24 hours after the start of the operation
Cardiopulmonary bypass time
Time Frame: Up to 24 hours after the start of the operation
Total cardiopulmonary bypass time (min)
Up to 24 hours after the start of the operation
Cross-clamp time
Time Frame: Up to 24 hours after the start of the operation
Total cross-clamp time (min)
Up to 24 hours after the start of the operation
Other arrhythmias rate
Time Frame: Within 30-day of surgery or until discharge, whichever came last, assessed up to 6 months after surgery
Any arrhytmias other than POAF rate
Within 30-day of surgery or until discharge, whichever came last, assessed up to 6 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vasily I. Kaleda

Investigators

  • Study Chair: Alexandr Piskun, M.D., Ph.D., Yudin Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 17, 2025

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

February 2, 2025

First Submitted That Met QC Criteria

February 6, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 19, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1.2025

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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