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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

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

• Informed consent

Locations
Other Locations
Russian Federation
Department of Cardiac Surgery, Yudin Hospital
RECRUITING
Moscow
Contact Information
Primary
Vasily I. Kaleda, M.D., Ph.D.
vasily.kaleda@gmail.com
7 (985) 641 1769
Time Frame
Start Date: 2025-02-17
Estimated Completion Date: 2027-09
Participants
Target number of participants: 216
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Vasily I. Kaleda

This content was sourced from clinicaltrials.gov