Safety, Performance, and Clinical Benefit of Pacing the Left Bundle Branch Area - Post-Market Clinical Follow-up
SEPTA PMCF
1 other identifier
observational
140
7 countries
13
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2025
Typical duration for all trials
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 29, 2025
CompletedFirst Posted
Study publicly available on registry
October 7, 2025
CompletedStudy Start
First participant enrolled
December 19, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2029
June 4, 2026
June 1, 2026
3.7 years
September 29, 2025
June 3, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
LBBA Implant Success Rate
Percentage of subjects in whom the INGEVITY+ lead is successfully implanted in the left bundle branch area (LBBA). Implant success is determined by ECG and procedural criteria, as defined per protocol.
At the time of implant procedure (Day 0).
Maintenance of Ventricular Synchrony (Paced QRS Duration)
Mean paced QRS duration measured by 12-lead ECG to assess preservation of ventricular synchrony.
From implant through 3-year follow-up.
Other Outcomes (1)
Lead-related Complication-Free Rate
From implant through 3 years.
Study Arms (1)
Patients receiving INGEVITY+ lead for left bundle branch area pacing
This group includes adult patients with bradycardia who are indicated for a Boston Scientific pacemaker system. All participants will undergo implantation of an INGEVITY+ pace/sense lead in the left bundle branch area (LBBAP) with a compatible Boston Scientific pacemaker.
Interventions
The pacemaker lead under investigation is a bipolar, steroid-releasing pacemaker electrode with active fixation (IS-1 connection) designed for chronic stimulation and sensing in the right atrium, right ventricle or left bundle branch area (LBBA). In this study, the lead is implanted in the LBBA and connected to a single- or dual-chamber pacemaker. Implantation is performed using a compatible, CE-marked catheter for pacemaker implantation.
Eligibility Criteria
Subjects included in SEPTA PMCF will be selected from the physician investigator's general patient population with a brady pacing indication for single or dual-chamber pacemaker implantation where LBBAP is preferred. Diverse racial and gender patient consideration should be implemented when determining potential participants.
You may qualify if:
- 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);
- 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:
- Symptomatic paroxysmal or permanent second- or third-degree AV block,
- Symptomatic bilateral bundle branch block,
- Symptomatic paroxysmal or transient sinus node dysfunction with or without associated AV conduction disorders (i.e., sinus bradycardia, sinus arrest, sinoatrial \[SA\] block),
- Bradycardia-tachycardia syndrome, to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias,
- Neurovascular (vasovagal) syndromes or hypersensitive carotid sinus syndromes,
- 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:
- Conduction disorders that require restoration of AV synchrony, including varying degrees of AV block,
- VVI intolerance (i.e., pacemaker syndrome) in the presence of persistent sinus rhythm,
- Low cardiac output or congestive heart failure secondary to bradycardia;
- 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;
- Subjects who are ≥18 years of age, and of legal age to give informed consent specific to state and national law.
You may not qualify if:
- Subjects meeting guideline indications for cardiac resynchronization therapy (CRT) in the absence of a bradycardia indication;
- Subjects with a known or suspected sensitivity to dexamethasone acetate (DXA);
- Subjects with a Mechanical Tricuspid Valve;
- Subjects requiring hemodialysis or peritoneal dialysis;
- 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;
- Subjects currently on an active organ transplant list;
- Subject referred to or admitted for hospice care;
- Subjects with a documented life expectancy of less than 12 months;
- Subjects enrolled in any other concurrent study (unless prior approval is received from the Sponsor);
- Subjects who are, or plan to become pregnant during the course of the study or are breastfeeding at time of enrollment;
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
St. Jan-Hospital
Bruges, 8000, Belgium
Clinique Saint-Pierre Ottignies-Hospital
Brussels, 1340, Belgium
CHRU de Lille
Lille, 59037, France
Hospital Europeen Georges-Pompidou (HEGP)
Paris, 75908, France
Marienhospital-Hospital
Osnabrück, Lower Saxony, 49074, Germany
Saarland University Hospital
Homburg, Saarland, 66421, Germany
Azienda Ospedaliero-Universitaria di Ferrara-Hospital
Ferrara, Emilia-Romagna, 44100, Italy
Azienda Ospedaliera Ospedale Niguarda Ca Granda
Milan, 20162, Italy
AOU Maggiore
Novara, 28100, Italy
Virgen de las Nieves University Hospital
Granada, 18014, Spain
Hospital Clinico Universitario Lozano Blesa
Zaragoza, 50009, Spain
Inselspital Bern
Bern, 3010, Switzerland
East Surrey Hospital
Redhill, Surrey, RH1 5RH, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Aurélien Wauters, MD, PhD
Clinique St-Pierre Ottignies
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 29, 2025
First Posted
October 7, 2025
Study Start
December 19, 2025
Primary Completion (Estimated)
August 31, 2029
Study Completion (Estimated)
August 31, 2029
Last Updated
June 4, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will not share