Actively Recruiting
Safety, Performance, and Clinical Benefit of Pacing the Left Bundle Branch Area - Post-Market Clinical Follow-up
Led by Boston Scientific Corporation · Updated on 2026-05-11
140
Participants Needed
13
Research Sites
193 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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...
- Intended for initial pacing system implant using the INGEVITY+ lead in the left bundle branch area and a Boston Scientific single- or dual-chamber pacemaker
- Indicated for and will receive a Boston Scientific pacemaker system for symptomatic second- or third-degree AV block, bilateral bundle branch block, sinus node dysfunction, bradycardia-tachycardia syndrome, neurovascular syndromes, or chronotropic incompetence
- Dual-chamber and atrial tracking modes indicated for patients needing AV synchrony restoration or treatment of conduction disorders
- Willing and able to give informed consent and participate in all study visits
- Aged 18 years or older and legally able to consent
You will not qualify if you...
- Indicated for cardiac resynchronization therapy without bradycardia indication
- Known or suspected sensitivity to dexamethasone acetate
- Presence of a mechanical tricuspid valve
- Requires hemodialysis or peritoneal dialysis
- Has had any implanted pacemaker, ICD, or CRT system before (except temporary pacing wire)
- Currently on an active organ transplant list
- Referred to or admitted for hospice care
- Life expectancy less than 12 months
- Enrolled in another concurrent study without sponsor approval
- Pregnant or breastfeeding at enrollment
- Unable or unwilling to comply with follow-up schedule or living too far from investigational site
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
Not Yet Recruiting
4
Hospital Europeen Georges-Pompidou (HEGP)
Paris, France, 75908
Not Yet 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
Not Yet 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)
CONTACT
G
Gena Kantor, MPH
CONTACT
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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