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

NCT07312149 | Not Yet Recruiting

• 1 other identifier: RC25_0420
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Atrial Fibrillation (AF); Cardiac Surgery

Keywords

Atrial firbrillation; Cardiac Surgery; PWI-Box; GeminiS

Outcome Measures

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.

  12 months

Secondary Outcomes (6)

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

  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.

  36 months

• Evaluation of the rate of secondary endocardial ablation of AF.

  12 months

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

  36 months

• Evaluate the rate of patients on anticoagulant and/or antiarrhythmic therapy after MAZE surgery.

  36 months

Study Arms (1)

BOXTER Study 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.).

Other: Collection of study data from patient records

Interventions

Collection of study data from patient records OTHER

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.

BOXTER Study population

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Charles-Henri DAVID

  Nantes University Hospital

  STUDY DIRECTOR

Central Study Contacts

Sponsor

CONTACT

02 53 48 28 35; bp-prom-regl@chu-nantes.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: December 31, 2025
• Study Start: January 5, 2026
• Primary Completion (Estimated): January 5, 2030
• Study Completion (Estimated): January 5, 2032
• Last Updated: January 6, 2026

Record last verified: 2026-01