Safety, Performance, and Clinical Benefit of Pacing the Left Bundle Branch Area - Post-Market Cli… (NCT07209852) | Clinical Trial Compass
RecruitingNot Applicable
Safety, Performance, and Clinical Benefit of Pacing the Left Bundle Branch Area - Post-Market Clinical Follow-up
Belgium, France, Germany140 participantsStarted 2025-12-19
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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);
What they're measuring
1
LBBA Implant Success Rate
Timeframe: At the time of implant procedure (Day 0).
2
Maintenance of Ventricular Synchrony (Paced QRS Duration)
✕. 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;