Atrial Fibrillation (AF)BoxTerNCT07312149
Isolation of Pulmonary Veins Using the Box Technique in Patients Undergoing Sternotomy
An observational study of Atrial Fibrillation (AF) and Cardiac Surgery, run by Nantes University Hospital at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation (AF), Cardiac Surgery
- What is being tested?
- Collection of study data from patient records
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 5 Oct 2026to 5 Oct 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
CHU de Nantes
Nantes, 44093
Charles-Henri DAVID, 0244768569, charleshenri.david@chu-nantes.fr
About this study
Official title: BoxTer : Isolation of Pulmonary Veins Using the Box Technique in Patients Undergoing Sternotomy
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.
Read more
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
- Being tested
- Collection of study data from patient records
- Keywords
- Atrial firbrillation, Cardiac Surgery, PWI-Box, GeminiS
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of study data from patient recordsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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.). Receives: Other: Collection of study data from patient records |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 36 months
Evaluation of the rate of secondary endocardial ablation of AF.
Measured: 12 months
Evaluation of clinicals predictive factors for recurrence of AF after MAZE.
Measured: 36 months
Evaluate the rate of patients on anticoagulant and/or antiarrhythmic therapy after MAZE surgery.
Measured: 36 months
Assessment of complication rates associated with the technique used during cardiac surgery.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2025
- Study start5 Oct 2026 (estimated)
- Primary completion5 Oct 2030 (estimated)
- Study completion5 Oct 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charles-Henri DAVID, Study director, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07312149
- Sponsor's protocol ID
- RC25_0420
- Acronym
- BoxTer
- Status last verified
- Jun 2026
- First submitted
- 16 Dec 2025
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BoxTer : Isolation of Pulmonary Veins Using the Box Technique in Patients Undergoing Sternotomy
- ClinicalTrials.gov ID
- NCT07312149
- Acronym / sponsor ID
- BoxTer / RC25_0420
- Conditions
- Atrial Fibrillation (AF), Cardiac Surgery
- Keywords
- Atrial firbrillation, Cardiac Surgery, PWI-Box, GeminiS
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 5 Oct 2026 (estimated)
- Primary completion
- 5 Oct 2030 (estimated)
- Study completion
- 5 Oct 2032 (estimated)
- First posted
- 31 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BOXTER Study population | – | Other: Collection of study data from patient recordsPatients 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.). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collection of study data from patient recordsCollection 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. | Other | BOXTER Study population |
Primary outcome
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
6 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.
Time frame: 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.
Time frame: 36 months
Evaluation of the rate of secondary endocardial ablation of AF.
Time frame: 12 months
Evaluation of clinicals predictive factors for recurrence of AF after MAZE.
Time frame: 36 months
Evaluate the rate of patients on anticoagulant and/or antiarrhythmic therapy after MAZE surgery.
Time frame: 36 months
Assessment of complication rates associated with the technique used during cardiac surgery.
Time frame: 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: Undecided
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ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION, Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Charles-Henri DAVID study director
Nantes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation (AF) and Cardiac Surgery, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sponsor (02 53 48 28 35 ext. +33, bp-prom-regl@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.