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General |
Study Status |
Study Pending |
Application Number / Requirement Number |
P150012 S158/ PAS001 |
Date Original Protocol Accepted |
11/08/2024
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Date Current Protocol Accepted |
 
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Study Name |
INGEVITY + LBBAP Post-Approval Study
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Device Name |
INGEVITY + Leads - Active Fixation
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General Study Protocol Parameters |
Study Design |
Prospective & Retrospective Study
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Data Source |
Sponsor Registry
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Comparison Group |
Objective Performance Criterion
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Analysis Type |
Analytical
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Detailed Study Protocol Parameters |
Study Objectives |
Real World Evidence (RWE) methodology study to establish the safety and effectiveness of INGEVITY + pacing leads for use in left bundle branch area pacing (LBBAP) for patients with a pacing indication. The study is prospective single-arm, non-randomized, observational cohort using RWE methodologies from the Electrophysiology Predictable and Sustainable Implementation of National Registries (EP PASSION) project.
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Study Population |
The study will include all patients registered in Boston Scientific’s device tracking database with an INGEVITY+ lead implanted in the LBBA until at least 1,013 leads are followed to 5 years post-implant. The study will also include patients with applicable data from the pre-market cohort.
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Sample Size |
At least 1,013 implanted leads for chronic safety endpoint. At least 141 implanted leads are required for the acute safety endpoint. At least 137 lead measurements through 60 months are required to evaluated effectiveness endpoints. Chronic safety endpoint drives overall sample size based on the following assumptions: • Expected performance = 95% • Performance goal = 92.5% • One-sided significance level = 2.5% • Power = 90%
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Key Study Endpoints |
Safety Endpoints Acute: The event-free rate from implant to 1 month. Chronic: The event-free rate from 1 to 60 months. Effectiveness Endpoints Effectiveness 1: Percent of pacing capture threshold (PCT) responders defined as PCT less than or equal to 2 V. Effectiveness 2: Percent of R-wave sensed amplitude responders defined as R-wave sensed amplitude greater than or equal to 5mV.
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Follow-up Visits and Length of Follow-up |
Visits: N/A Length of F/U: Patients will be followed through at least 5 years following the end of enrollment.
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