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NCT Number: NCT06823778

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

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.

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Key information

Conditions

Postoperative Atrial Fibrillation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Cardiac Surgery, Yudin Hospital

Moscow, 115446, Russia

Location status: Recruiting

Location contact

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

CONTACT

[email protected]

7 (985) 641 1769

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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

  3. Length of Stay

    Time frame: Up to 6 months after surgery

    Postoperative length of in-hospital stay

  4. Unplanned Readmission

    Time frame: Within 30 days after surgery

    Unplanned 30-day any cause readmission rate

Other outcomes

  1. Operative time

    Time frame: Up to 24 hours after the start of the operation

    Total operative time (min)

  2. Cardiopulmonary bypass time

    Time frame: Up to 24 hours after the start of the operation

    Total cardiopulmonary bypass time (min)

  3. Cross-clamp time

    Time frame: Up to 24 hours after the start of the operation

    Total cross-clamp time (min)

  4. 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

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

7 (985) 641 1769

Sponsors and collaborators

Lead sponsor

Vasily I. Kaleda

Other

Registry information

Official study title

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

Acronym: PROBOX

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 12, 2025
Registry last updated
Feb 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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