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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

Postoperative Atrial Fibrillation

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

Plain Language Summary

Simplified for easier understanding

This study is testing whether performing a preventive radiofrequency ablation (a procedure that uses heat to destroy small areas of heart tissue) on the back wall of the left atrium can reduce the chance of atrial fibrillation (an irregular heartbeat) returning after surgery. **You may be eligible if...** - You are 18 or older - You have atrial fibrillation or flutter and are scheduled for heart surgery - Your doctor recommends ablation as part of your treatment plan - You are in acceptable health for the procedure **You may NOT be eligible if...** - You have had a previous ablation procedure for atrial fibrillation - You have severe valve disease not being corrected in this surgery - You have had a stroke in the past 3 months - You have a blood clot in your heart - Your heart's left ventricle function is severely reduced Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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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