Conduction System Pacing With INGEVITY+
- Conditions
- Bradycardia
- Interventions
- Device: Cardiac pacing
- Registration Number
- NCT06014866
- Lead Sponsor
- Duke University
- 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 rate (safety) and lead measurements (performance).
Data will be gathered by means of a retrospective, multi-center, US only observational chart review to obtain data on INGEVITY+ leads implanted in the LBBA. Additional data will be gathered from the pulse generator and from the LATITUDE remote monitoring system for pacing thresholds and R-wave amplitude. Consecutive implants will be collected from each site for evaluating the endpoints.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1383
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description LBBA INGEVITY+ Pacing Cardiac pacing Patients indicated for anti-bradycardia pacing that have been implanted with an INGEVITY+ lead in the LBBA.
- Primary Outcome Measures
Name Time Method Lead-Related Complication Free Rate Implant through 90 days Adverse events that require correction with an invasive intervention or resulted in significant loss of device functionality.
Pacing Threshold Implant through 90 days Percent of INGEVITY+ leads with pacing capture threshold measurement of less than or equal to 2V.
Sensed R-wave amplitude Implant through 90 days Percent of INGEVITY+ leads with an R-wave amplitude greater than 5mV.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (8)
Sarasota Memorial Health Care System
🇺🇸Sarasota, Florida, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
Community Heart And Vascular Hospital
🇺🇸Indianapolis, Indiana, United States
TriHealth Bethesda North Hospital
🇺🇸Cincinnati, Ohio, United States
Houston Methodist Sugar Land Hospital
🇺🇸Sugar Land, Texas, United States
Essentia Health - Saint Mary's Duluth Clinic
🇺🇸Duluth, Minnesota, United States
NewYork-Presbyterian Queens
🇺🇸Flushing, New York, United States
Duke University
🇺🇸Durham, North Carolina, United States