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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVasily I. Kaleda

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Informed consent

Disqualifiers

History of atrial fibrillation/flutter

Minimally invasive approach

Off-pump surgery

Emergent/salvage surgery

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

216 Participants
are divided into 2 treatment groups
Group A: ControlNo intervention 0 interventions
Group B: InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Postoperative Atrial Fibrillation

Incidence of clinically significant (requiring any type of intervention) postoperative atrial fibrillation

Time frame
Within 30-day of surgery or until discharge, whichever came last, assessed up to 6 months after surgery

Secondary outcomes

1

Postoperative Mortality

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.

Time frame
Within 30-day of surgery or until discharge, whichever came last, assessed up to 6 months after surgery
2

Postoperative Stroke

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

Time frame
Within 30-day of surgery or until discharge, whichever came last, assessed up to 6 months after surgery
3

Length of Stay

Postoperative length of in-hospital stay

Time frame
Up to 6 months after surgery
4

Unplanned Readmission

Unplanned 30-day any cause readmission rate

Time frame
Within 30 days after surgery

Other outcomes

1

Operative time

Total operative time (min)

Time frame
Up to 24 hours after the start of the operation
2

Cardiopulmonary bypass time

Total cardiopulmonary bypass time (min)

Time frame
Up to 24 hours after the start of the operation
3

Cross-clamp time

Total cross-clamp time (min)

Time frame
Up to 24 hours after the start of the operation
4

Other arrhythmias rate

Any arrhytmias other than POAF rate

Time frame
Within 30-day of surgery or until discharge, whichever came last, assessed up to 6 months after surgery

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vasily I. Kaleda

Lead sponsor

Yudin Hospital

Sponsor institution