Status:
COMPLETED
Conduction System Pacing With INGEVITY+
Lead Sponsor:
Duke University
Collaborating Sponsors:
Boston Scientific Corporation
Conditions:
Bradycardia
Eligibility:
All Genders
1+ years
Brief Summary
The study is intended to evaluate the safety and effectiveness of the Boston Scientific INGEVITY+ cardiac pacing lead when implanted in the left bundle branch area (LBBA).
Detailed Description
INSIGHT is a prospectively defined analysis of INGEVITY+ leads that have been previously implanted in the LBBA for the purpose of anti-bradycardia pacing. The results will provide complication free ra...
Eligibility Criteria
Inclusion
- Inclusion Criteria for Primary Analysis:
- De novo anti-bradycardia pacing pacemaker implant.
- INGEVITY+ lead implant attempt in the LBBA as documented in the medical record at least 90 days ago.
- LBBAP implant attempt employed a Boston Scientific SSPC series sheath
- Exclusion Criteria for Primary Analysis:
- ICD and CRT-D devices
Exclusion
Key Trial Info
Start Date :
November 13 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 27 2024
Estimated Enrollment :
1383 Patients enrolled
Trial Details
Trial ID
NCT06014866
Start Date
November 13 2023
End Date
August 27 2024
Last Update
May 23 2025
Active Locations (8)
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1
Sarasota Memorial Health Care System
Sarasota, Florida, United States, 34233
2
University of Chicago
Chicago, Illinois, United States, 60637
3
Community Heart And Vascular Hospital
Indianapolis, Indiana, United States, 46227
4
Essentia Health - Saint Mary's Duluth Clinic
Duluth, Minnesota, United States, 55805