Left bundle branch area pacing with the INGEVITY+ pacemaker lead

Safety, Performance, and Clinical Benefit of Pacing the Left Bundle Branch Area - Post-Market Clinical Follow-up (SEPTA PMCF)

This will see if using the INGEVITY+ pacemaker lead to pace the left bundle branch area is safe and helpful over the long term for people with bradycardia or related conduction problems who need a new pacemaker.

Quick facts

• Study type: Observational
• Enrollment: 140 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Boston Scientific Corporation (industry)
• Locations: 13 sites (Bruges and 12 other locations)
• Trial ID: NCT07209852 on ClinicalTrials.gov

What this trial studies

This is an observational post‑market follow‑up that will enroll patients receiving a de novo Boston Scientific single- or dual‑chamber pacemaker with an INGEVITY+ lead placed in the left bundle branch area. Investigators will collect long‑term data on lead performance, device function, procedure‑related complications, and clinical outcomes in typical pacing indications such as AV block, sinus node dysfunction, and bundle‑branch block. There is no randomization—patients receive standard care and undergo scheduled device checks and clinical follow‑up visits. The study is being conducted at multiple centers in Belgium and France to capture real‑world performance.

Who should consider this trial

Good fit: Ideal candidates are adults scheduled for a new (de novo) Boston Scientific single‑ or dual‑chamber pacemaker implant with placement of an INGEVITY+ lead in the left bundle branch area for indications like symptomatic AV block, sinus node dysfunction, or bundle‑branch block.

Not a fit: Patients who already have an implanted pacemaker or prior attempted pacing system components, those not suitable for left bundle branch area placement, or those whose rhythm problem is unrelated to conduction system disease may not receive benefit.

Why it matters

Potential benefit: If successful, this could provide a more physiologic pacing option that preserves conduction and may reduce pacing‑related complications for people needing pacemakers.

How similar studies have performed: Conduction system pacing approaches including left bundle branch area pacing have shown promising short‑ and mid‑term results in other studies, but longer‑term and device‑specific post‑market evidence is still emerging.

Eligibility criteria

Inclusion Criteria:

1. Subjects intended to undergo initial (de novo) pacing system implant using the INGEVITY+ lead in the left bundle branch area (LBBA) and a Boston Scientific single or dual- chamber pacemaker (Note: no prior attempted pacing system components);
2. Subjects who are indicated for and will receive a Boston Scientific pacemaker system (including the single or dual chamber pacemaker and an INGEVITY+ lead in the LBBA location) for one of the following medical conditions:

   1. Symptomatic paroxysmal or permanent second- or third-degree AV block,
   2. Symptomatic bilateral bundle branch block,
   3. Symptomatic paroxysmal or transient sinus node dysfunction with or without associated AV conduction disorders (i.e., sinus bradycardia, sinus arrest, sinoatrial \[SA\] block),
   4. Bradycardia-tachycardia syndrome, to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias,
   5. Neurovascular (vasovagal) syndromes or hypersensitive carotid sinus syndromes,
   6. Adaptive-rate pacing for patients exhibiting chronotropic incompetence and who may benefit from increased pacing rates concurrent with increases in minute ventilation and/or level of physical activity.

      Dual-chamber and atrial tracking modes are also indicated for patients who may benefit from maintenance of AV synchrony. Dual chamber modes are specifically indicated for treatment of the following:
   7. Conduction disorders that require restoration of AV synchrony, including varying degrees of AV block,
   8. VVI intolerance (i.e., pacemaker syndrome) in the presence of persistent sinus rhythm,
   9. Low cardiac output or congestive heart failure secondary to bradycardia;
3. Subjects willing and capable of providing informed consent and participating in all testing and clinic visits associated with the clinical study at an approved clinical study location and at the intervals defined by protocol;
4. Subjects who are ≥18 years of age, and of legal age to give informed consent specific to state and national law.

Exclusion Criteria:

1. Subjects meeting guideline indications for cardiac resynchronization therapy (CRT) in the absence of a bradycardia indication;
2. Subjects with a known or suspected sensitivity to dexamethasone acetate (DXA);
3. Subjects with a Mechanical Tricuspid Valve;
4. Subjects requiring hemodialysis or peritoneal dialysis;
5. Subject has or has had implanted any pacemaker, ICD system, including subcutaneous, transvenous or leadless systems (Note: except for temporary pacing wire at time of enrollment) or CRT system;
6. Subjects currently on an active organ transplant list;
7. Subject referred to or admitted for hospice care;
8. Subjects with a documented life expectancy of less than 12 months;
9. Subjects enrolled in any other concurrent study (unless prior approval is received from the Sponsor);
10. Subjects who are, or plan to become pregnant during the course of the study or are breastfeeding at time of enrollment;
11. Subjects who are unable or unwilling to comply with the follow-up schedule, including those living at such a distance from the investigational site that attending follow-up visits would be unusually difficult or burdensome.

Where this trial is running

Bruges and 12 other locations

• St. Jan-Hospital — Bruges, Belgium (RECRUITING)
• Clinique Saint-Pierre Ottignies-Hospital — Brussels, Belgium (RECRUITING)
• CHRU de Lille — Lille, France (NOT_YET_RECRUITING)
• Hospital Europeen Georges-Pompidou (HEGP) — Paris, France (NOT_YET_RECRUITING)
• Marienhospital-Hospital — Osnabrück, Lower Saxony, Germany (NOT_YET_RECRUITING)
• Saarland University Hospital — Homburg, Saarland, Germany (NOT_YET_RECRUITING)
• Azienda Ospedaliero-Universitaria di Ferrara-Hospital — Ferrara, Emilia-Romagna, Italy (NOT_YET_RECRUITING)
• Azienda Ospedaliera Ospedale Niguarda Ca Granda — Milan, Italy (NOT_YET_RECRUITING)
• AOU Maggiore — Novara, Italy (NOT_YET_RECRUITING)
• Virgen de las Nieves University Hospital — Granada, Spain (RECRUITING)
• Hospital Clinico Universitario Lozano Blesa — Zaragoza, Spain (RECRUITING)
• Inselspital Bern — Bern, Switzerland (NOT_YET_RECRUITING)
• East Surrey Hospital — Redhill, Surrey, United Kingdom (RECRUITING)

Study contacts

• Principal investigator: Aurélien Wauters, MD, PhD — Clinique St-Pierre Ottignies
• Study coordinator: Jens Goetzke, Dipl.-Ing. (FH)

Conditions: Bradycardia, Atrioventricular Block, Sinus Node Dysfunction, Bundle-Branch Block, Left Bundle Branch Area Pacing, INGEVITY+ Lead, Pacemaker, Cardiac Pacing