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NCT07209852From ClinicalTrials.govRecruiting

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

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

  • Bradycardia
  • Atrioventricular Block
  • Sinus Node Dysfunction
  • Bundle-Branch Block

At a glance

Phase
Phase not stated
Study type
Observational
Sponsor
Boston Scientific Corporation
Enrolment target
140
Started
19 December 2025
Main results due
31 August 2029
Study sites
13
Registry updated
25 September 2026

Can you take part?

  • Aged 18 years and over.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full 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.

What this study is about

In the sponsor’s own words, from the registry.

The goal of this observational post-market clinical Follow-up study is to learn about the long-term safety, performance, and clinical benefits of pacing the left bundle branch area (LBBAP) using the INGEVITY+ pacemaker lead in patients with bradycardia who need a pacemaker.

Study sites(13)

  • St. Jan-Hospital

    Bruges, Belgium

    Recruiting

  • Clinique Saint-Pierre Ottignies-Hospital

    Brussels, Belgium

    Recruiting

  • CHRU de Lille

    Lille, France

    Recruiting

  • Hospital Europeen Georges-Pompidou (HEGP)

    Paris, France

    Recruiting

  • Marienhospital-Hospital

    Osnabrück, Lower Saxony, Germany

    Recruiting

  • Saarland University Hospital

    Homburg, Saarland, Germany

    Not yet recruiting

  • Azienda Ospedaliero-Universitaria di Ferrara-Hospital

    Ferrara, Emilia-Romagna, Italy

    Recruiting

  • Azienda Ospedaliera Ospedale Niguarda Ca Granda

    Milan, Italy

    Not yet recruiting

  • AOU Maggiore

    Novara, Italy

    Recruiting

  • Virgen de las Nieves University Hospital

    Granada, Spain

    Recruiting

  • Hospital Clinico Universitario Lozano Blesa

    Zaragoza, Spain

    Recruiting

  • Inselspital Bern

    Bern, Switzerland

    Recruiting

  • East Surrey Hospital

    Redhill, Surrey, United Kingdom

    Recruiting

Showing 13 of 13 sites. 11 of the 13 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07209852. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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Safety, Performance, and Clinical Benefit of Pacing the Left Bundle Branch Area - Post-Market Clinical Follow- | Trialion