Postoperative Atrial Fibrillation
Conditions
Keywords
Postoperative Atrial Fibrillation, Radiofrequency Ablation, Box Lesion Ablation, Prophylactic Ablation
Brief 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.
Detailed description
Postoperative atrial fibrillation (POAF) is a common complication after heart surgery that occurs in 10-60% of patients. It can cause hypotension, tachycardia, stroke, systemic embolism, or heart failure, and is associated with increased mortality rates, prolonged hospital stays and increased costs. Several studies have investigated the use of radiofrequency ablation (the standard of surgical care for atrial fibrillation during concomitant cardiac surgery when the diagnosis is known preoperatively) to prevent POAF. However, these studies were limited mainly to pulmonary vein isolation and had methodological limitations such as small sample sizes, inclusion/exclusion criteria, and randomization procedures, and have not translated into clinical practice changes. The current study aims to investigate the use of radiofrequency left atrial posterior wall isolation, also known as box lesion ablation, as a more effective treatment compared to pulmonary vein isolation, in a properly designed randomized controlled trial.
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.
Sponsors
Vasily I. Kaleda
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Intervention model description
A Prospective Parallel-Arm Single-Blind Randomized Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All patients undergoing cardiac surgery by a single surgeon (V.K.) * Informed consent
Exclusion criteria
* History of atrial fibrillation/flutter * Minimally invasive approach * Off-pump surgery * Emergent/salvage surgery * Severe pericardial adhesions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Atrial Fibrillation | Within 30-day of surgery or until discharge, whichever came last, assessed up to 6 months after surgery | Incidence of clinically significant (requiring any type of intervention) postoperative atrial fibrillation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Mortality | Within 30-day of surgery or until discharge, whichever came last, assessed up to 6 months after surgery | 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. |
| Postoperative Stroke | Within 30-day of surgery or until discharge, whichever came last, assessed up to 6 months after surgery | 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 |
| Length of Stay | Up to 6 months after surgery | Postoperative length of in-hospital stay |
| Unplanned Readmission | Within 30 days after surgery | Unplanned 30-day any cause readmission rate |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cardiopulmonary bypass time | Up to 24 hours after the start of the operation | Total cardiopulmonary bypass time (min) |
| Cross-clamp time | Up to 24 hours after the start of the operation | Total cross-clamp time (min) |
| Other arrhythmias rate | Within 30-day of surgery or until discharge, whichever came last, assessed up to 6 months after surgery | Any arrhytmias other than POAF rate |
| Operative time | Up to 24 hours after the start of the operation | Total operative time (min) |
Countries
Russia
Contacts
Primary ContactVasily I. Kaleda, M.D., Ph.D.
Outcome results
None listed