RecruitingNot ApplicableNCT06823778

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

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


Sponsor

Vasily I. Kaleda

Enrollment

216 participants

Start Date

Feb 17, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria2

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

Exclusion Criteria5

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

Interventions

DEVICERadiofrequency 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.


Locations(1)

Department of Cardiac Surgery, Yudin Hospital

Moscow, Moscow, Russia

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NCT06823778


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