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

Recruiting Observational Study
Bradycardia Atrioventricular Block Sinus Node Dysfunction Bundle-Branch Block
No Placebo Group Every participant receives an active treatment — no one gets a placebo. No Study Drug Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
140 (estimated)
Sponsor
Boston Scientific Corporation · Industry
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About This Trial

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 Locations
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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…
Contacts

Jens Goetzke, Dipl.-Ing. (FH)

800-227-3422

septa_pmcf@bsci.com

CONTACT

Gena Kantor, MPH

800-227-3422

septa_pmcf@bsci.com

CONTACT