Actively Recruiting
Safety, Performance, and Clinical Benefit of Pacing the Left Bundle Branch Area Using the INGEVITY+ Pacemaker Lead - Post-Market Clinical Follow-up
Led by Boston Scientific Corporation · Updated on 2026-06-04
140
Participants Needed
13
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the long-term safety, performance, and clinical benefits of pacing the left bundle branch area (LBBAP) using the INGEVITY+ pacemaker lead in adults with bradycardia who need a pacemaker. This observational post-market clinical follow-up study focuses on patients with conditions such as atrioventricular block, sinus node dysfunction, and bundle-branch block. Participants will receive implantation of the INGEVITY+ bipolar, steroid-releasing pacemaker lead in the left bundle branch area, connected to a compatible Boston Scientific single- or dual-chamber pacemaker. The implantation is performed using a CE-marked catheter. The study includes only patients undergoing their first implant with this system, and all will be monitored over time. During the study, participants will attend clinic visits and undergo assessments at defined intervals to monitor implant success, maintenance of ventricular synchrony through paced QRS duration, and overall device performance and safety. The goal is to gather data on how well the device works and its effects on patients over a follow-up period lasting up to three years.
CONDITIONS
Brief Title
Safety, Performance, and Clinical Benefit of Pacing the Left Bundle Branch Area - Post-Market Clinical Follow-up
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years of age or older able to give informed consent.
- Patients scheduled for their first implantation of a Boston Scientific single or dual-chamber pacemaker with an INGEVITY+ lead placed in the left bundle branch area.
- Patients with symptomatic bradycardia conditions including second- or third-degree AV block, bilateral bundle branch block, sinus node dysfunction, bradycardia-tachycardia syndrome, neurovascular or carotid sinus syndromes, or chronotropic incompetence.
- Patients who can participate in all study visits at approved locations according to the study schedule.
You will not qualify if you...
- Patients indicated for cardiac resynchronization therapy (CRT) without a bradycardia indication.
- Known or suspected sensitivity to dexamethasone acetate.
- Presence of a mechanical tricuspid valve.
- Patients requiring hemodialysis or peritoneal dialysis.
- History of any pacemaker, ICD, or CRT system implantation (except temporary pacing wire at enrollment).
- Patients on an active organ transplant list.
- Patients referred to or admitted for hospice care.
- Life expectancy less than 12 months.
- Enrollment in another clinical study without prior sponsor approval.
- Pregnant or breastfeeding women, or those planning pregnancy during the study.
- Inability or unwillingness to comply with the follow-up schedule or living too far from the study site to attend visits.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day 0
Participants undergo implantation of the INGEVITY+ pacemaker lead in the left bundle branch area using a compatible pacemaker system.
1 visit (in-person)
Duration - Up to 3 years
Participants are monitored for the safety, performance, and clinical benefits of the pacemaker lead, including maintenance of ventricular synchrony.
Regular visits according to study schedule
Trial Site Locations
Total: 13 locations
1
St. Jan-Hospital
Bruges, Belgium, 8000
Actively Recruiting
2
Clinique Saint-Pierre Ottignies-Hospital
Brussels, Belgium, 1340
Actively Recruiting
3
CHRU de Lille
Lille, France, 59037
Actively Recruiting
4
Hospital Europeen Georges-Pompidou (HEGP)
Paris, France, 75908
Actively Recruiting
5
Marienhospital-Hospital
Osnabrück, Lower Saxony, Germany, 49074
Not Yet Recruiting
6
Saarland University Hospital
Homburg, Saarland, Germany, 66421
Not Yet Recruiting
7
Azienda Ospedaliero-Universitaria di Ferrara-Hospital
Ferrara, Emilia-Romagna, Italy, 44100
Not Yet Recruiting
8
Azienda Ospedaliera Ospedale Niguarda Ca Granda
Milan, Italy, 20162
Not Yet Recruiting
9
AOU Maggiore
Novara, Italy, 28100
Actively Recruiting
10
Virgen de las Nieves University Hospital
Granada, Spain, 18014
Actively Recruiting
11
Hospital Clinico Universitario Lozano Blesa
Zaragoza, Spain, 50009
Actively Recruiting
12
Inselspital Bern
Bern, Switzerland, 3010
Not Yet Recruiting
13
East Surrey Hospital
Redhill, Surrey, United Kingdom, RH1 5RH
Actively Recruiting
Research Team
J
Jens Goetzke, Dipl.-Ing. (FH)
G
Gena Kantor, MPH
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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