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).
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.
Study Type
OBSERVATIONAL
Enrollment
1,383
Patient's previously implanted with the INGEVITY+ lead located in the LBBA
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
Essentia Health - Saint Mary's Duluth Clinic
Duluth, Minnesota, United States
Lead-Related Complication Free Rate
Adverse events that require correction with an invasive intervention or resulted in significant loss of device functionality.
Time frame: Implant through 90 days
Pacing Threshold
Percent of INGEVITY+ leads with pacing capture threshold measurement of less than or equal to 2V.
Time frame: Implant through 90 days
Sensed R-wave amplitude
Percent of INGEVITY+ leads with an R-wave amplitude greater than 5mV.
Time frame: Implant through 90 days
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NewYork-Presbyterian Queens
Flushing, New York, United States
Duke University
Durham, North Carolina, United States
TriHealth Bethesda North Hospital
Cincinnati, Ohio, United States
Houston Methodist Sugar Land Hospital
Sugar Land, Texas, United States