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

Официальное название

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

Обзор

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.

Вмешательства

• Другое Collection of study data from patient records
  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.

Первичные конечные точки

• 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. [Срок оценки: 12 months]

Вторичные конечные точки (6)

• Evaluation of the efficacy of the PWI box using GeminiS in combination with other cardiac surgery procedures via sternotomy at 2 years postoperatively. [Срок оценки: 24 months]
• Evaluation of the efficacy of the PWI box using GeminiS in combination with other cardiac surgery procedures via sternotomy at 3 years postoperatively. [Срок оценки: 36 months]
• Evaluation of the rate of secondary endocardial ablation of AF. [Срок оценки: 12 months]
• Evaluation of clinicals predictive factors for recurrence of AF after MAZE. [Срок оценки: 36 months]
• Evaluate the rate of patients on anticoagulant and/or antiarrhythmic therapy after MAZE surgery. [Срок оценки: 36 months]
• Assessment of complication rates associated with the technique used during cardiac surgery. [Срок оценки: 36 months]

Критерии участия

Критерии включения

• 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
• Informed patient who did not object to the collection of their data for the study

Критерии исключения

• Unplanned surgery (emergency)
• History of cardiac surgery (reoperation)
• Pregnant or breastfeeding women
• Adults under guardianship, curatorship or judicial protection
• Patients with a life expectancy of less than three years
• Patients currently taking medication or using an experimental device that clinically interferes with the study's evaluation criteria and results.
• Inability to comply with the monitoring schedule.
• Contraindication to long-term anticoagulants

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 1 центр

• CHU de Nantes — Nantes

Идентификаторы

NCT: NCT07312149 · RC25_0420

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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