About this trial
Atrial Fibrillation (AF) is the most common cardiac arrhythmia worldwide, affecting approximately 2.8% of the population, with prevalence increasing with age. AF is associated with significant morbidity and mortality, accounting for about 25% of ischemic strokes, 10% of cryptogenic strokes, and a 10-40% annual increase in hospital admissions due to heart failure or anticoagulant-related events.
About 10% of patients undergoing cardiac surgery have preoperative AF. In 1986, Dr. Cox introduced the MAZE procedure, a surgical technique to isolate AF triggers. Initially involving atrial incisions, it evolved to use radiofrequency lines, significantly reducing morbidity and mortality. The MAZE procedure is now strongly recommended (Class Ia evidence) for concomitant cardiac surgery. However, nearly 85% of eligible patients-especially those undergoing closed-chest cardiac surgery-do not receive this treatment due to technical challenges and limited reproducibility of the Cox-Maze IV technique.
Pulmonary Vein Isolation (PVI) with posterior wall isolation (PWI-Box) has emerged as an effective alternative, offering similar outcomes to Cox-Maze IV with fewer adverse effects. Innovative devices like the GeminiS (Medtronic) enable minimally invasive, thoracoscopic PVI-PWI-Box procedures without opening the heart, even off-pump. This approach could expand the use of AF ablation during combined sternotomy surgeries, aligning with clinical guidelines.
Primary Objective: Assess the efficacy of PWI-Box using GeminiS combined with other cardiac surgeries via sternotomy.
Primary Endpoint: Recurrence rate of paroxysmal or persistent AF (per ESC definition) at 1 year postoperatively, confirmed by 24-hour Holter monitoring.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients undergoing cardiac surgery via sternotomy
Concomitant use of the PWI box with GeminiS during surgery
Adult patients
Patients with the following characteristics: Preoperative paroxysmal/persistent/permanent AF; Duration of less than 5 years; And left atrium volume <60 ml/m2
Disqualifiers
Unplanned surgery (emergency)
History of cardiac surgery (reoperation)
Pregnant or breastfeeding women
Adults under guardianship, curatorship or judicial protection
Trial population
Patients with a surgical indication for AF in combination with conventional cardiac surgery performed by sternotomy (coronary artery bypass grafting, aortic valve replacement, aortic surgery, etc.). Patients may be included prospectively, via information provided by the attending physician during a consultation (written and oral), or retrospectively for those who have already undergone surgery, by sending an information notice with a non-objection period.
Trial design
Cohort
Retrospective
Treatments tested in this trial
Collection of study data from patient records
Other interventionCollection of study data from patient records in the EPICARD national database at the time of surgery, 1 month post-surgery, 12 months post-surgery, 24 months post-surgery and 36 months post-surgery.
Treatment groups
Trial outcomes
Primary outcomes
Evaluate the efficacy of the PWI box, using GeminiS in combination with other cardiac surgery procedures via sternotomy, at 1 year post-operatively using 24-hour Holter monitoring.
Secondary outcomes
Evaluation of the efficacy of the PWI box using GeminiS in combination with other cardiac surgery procedures via sternotomy at 2 years postoperatively.
Evaluation of the efficacy of the PWI box using GeminiS in combination with other cardiac surgery procedures via sternotomy at 3 years postoperatively.
Evaluation of the rate of secondary endocardial ablation of AF.
Evaluation of clinicals predictive factors for recurrence of AF after MAZE.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: