Safety, Performance, and Clinical Benefit of Pacing the Left Bundle Branch Area - Post-Market Clinical Follow-up
Trial Parameters
Brief 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.
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 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: 1. Symptomatic paroxysmal or permanent second- or third-degree AV block, 2. Symptomatic bilateral bundle branch block, 3. Symptomatic paroxysmal or transient sinus node dysfunction with or without associated AV conduction disorders (i.e., sinus bradycardia, sinus arrest, sinoatrial \[SA\] block), 4. Bradycardia-tachycardia syndrome, to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias, 5. Neurovascular (vasovagal) syndromes or hypersensitive carotid sinus syndromes, 6. Adaptiv