Prophylactic ablation during cardiac surgery in patients without atrial fibrillation: a systematic review and meta-analysis of randomized trials.
Mika'il Visanji, Emilie P Belley-Côté, Ashok Pandey...
https://pubmed.ncbi.nlm.nih.gov/39589863/Actively Recruiting
Led by Vasily I. Kaleda · Updated on 2025-02-21
216
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are evaluating whether epicardial radiofrequency left atrial posterior wall isolation, also known as box lesion ablation, can prevent postoperative atrial fibrillation POAF after cardiac surgery. POAF is a common complication occurring in 10-60% of heart surgery patients and can lead to serious issues like stroke, heart failure, and longer hospital stays. This trial compares the box lesion ablation to no ablation to see if it reduces the number of patients experiencing new atrial fibrillation requiring treatment after surgery. Participants will either receive the radiofrequency ablation during their cardiac surgery or no ablation at all. The ablation is done using the AtriCure Isolator Synergy OLL2 bipolar radiofrequency clamp without opening the left atrium. The study includes a control group with no ablation and an intervention group undergoing the box lesion ablation. This is a randomized controlled trial designed to provide clearer evidence than prior smaller studies. During the study, data will be collected while participants are in the hospital. Additional follow-up information will be obtained 30 days after surgery by phone or in person. Researchers will measure the occurrence of postoperative atrial fibrillation within 30 days or until discharge, and will also track outcomes like mortality, stroke, length of hospital stay, and unplanned readmissions up to six months after surgery. The total participation period covers these monitoring and follow-up phases.
CONDITIONS
Prophylactic Radiofrequency Left Atrial Posterior Wall Isolation to Prevent Atrial Fibrillation After Cardiac Surgery
V
Vasily I. Kaleda, M.D., Ph.D.
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Vasily I. Kaleda
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Hospital stay until discharge
Participants undergo cardiac surgery with or without radiofrequency left atrial posterior wall isolation (box lesion ablation) during the procedure.
Hospitalization period with continuous monitoring
Duration - Up to 6 months after surgery
Participants are monitored for postoperative atrial fibrillation, mortality, stroke, length of hospital stay, and unplanned readmissions.
Follow-up visits up to 6 months post-surgery
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Mika'il Visanji, Emilie P Belley-Côté, Ashok Pandey...
https://pubmed.ncbi.nlm.nih.gov/39589863/Vasily I Kaleda, Mikhail A Snegirev, Vidadi U Efendiev...
https://pubmed.ncbi.nlm.nih.gov/39960384/Vasily I. Kaleda
Lead Sponsor