Safety, Performance, and Clinical Benefit of Pacing the Left Bundle Branch Area - Post-Market Clinical Follow-up
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBoston Scientific Corporation
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.
Eligibility criteria
Qualifiers
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);
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),
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Pacemaker lead
Treatment groups
140 Participants
are divided into 1 treatment groupLocations
13Belgium
St. Jan-Hospital8000, Bruges Belgium
Clinique Saint-Pierre Ottignies-Hospital1340, Brussels Belgium
France
CHRU de Lille59037, Lille France
Hospital Europeen Georges-Pompidou (HEGP)75908, Paris France
Sponsors and collaborators
Boston Scientific Corporation
Lead sponsor
Source ClinicalTrials.gov