ClinicaliQ Trial Snapshot
- Safety, Performance, and Clinical Benefit of Pacing the Left Bundle Branch Area – Post-Market Clinical Follow-up — Recruiting • Cardiology / Cardiovascular • NCT07209852.
- 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.
- Sponsor: Boston Scientific Corporation.
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What This Trial Is Studying
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 Snapshot
- : 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. 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. Dual-chamber and atrial tracking modes are also indicated for patients who may benefit from maintenance of AV synchrony. Dual chamber modes are specifically indicated for treatment of the following: 7. Conduction disorders that require restoration of…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.