Isolation of Pulmonary Veins Using the Box Technique in Patients Undergoing Sternotomy

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNantes University Hospital

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • Collection of study data from patient records

    Other intervention

    Collection 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

200 Participants
are divided into 1 treatment group
Group A: BOXTER Study population1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
12 months

Secondary outcomes

1

Evaluation of the efficacy of the PWI box using GeminiS in combination with other cardiac surgery procedures via sternotomy at 2 years postoperatively.

Time frame
24 months
2

Evaluation of the efficacy of the PWI box using GeminiS in combination with other cardiac surgery procedures via sternotomy at 3 years postoperatively.

Time frame
36 months
3

Evaluation of the rate of secondary endocardial ablation of AF.

Time frame
12 months
4

Evaluation of clinicals predictive factors for recurrence of AF after MAZE.

Time frame
36 months

Other outcomes

Sponsors and contacts

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