Clinical trial NCT06014866: Conduction System Pacing With INGEVITY+
Official title: ConductIoN System pacInG witH IngeviTy+ for the Left Bundle Branch Area
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bradycardia
Keywords: Conduction system pacing
Cardiac physiologic pacing
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
First posted: 2023-08-28
Enrollment: 1383
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients implanted with an INGEVITY+ lead implanted in the LBBA to provide rate support for bradycardia.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Lead-Related Complication Free Rate
timeFrame: Implant through 90 days
measure: Pacing Threshold
timeFrame: Implant through 90 days
measure: Sensed R-wave amplitude
timeFrame: Implant through 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Sarasota
country: United States
facility: Sarasota Memorial Health Care System
state: Florida
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Indianapolis
country: United States
facility: Community Heart And Vascular Hospital
state: Indiana
city: Duluth
country: United States
facility: Essentia Health - Saint Mary's Duluth Clinic
state: Minnesota
city: Flushing
country: United States
facility: NewYork-Presbyterian Queens
state: New York
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Cincinnati
country: United States
facility: TriHealth Bethesda North Hospital
state: Ohio
city: Sugar Land
country: United States
facility: Houston Methodist Sugar Land Hospital
state: Texas
Study officials:
affiliation: Duke University
name: Daniel Friedman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Friedman DJ, Shadrin I, Goldbarg S, Trulock KM, Patel A, Loring Z, Coles SA, Gandhi G, Upadhyay GA, Wold N, Jones PW, Ruble SB, Weinstock J, Latanich CA. Performance of an active fixation stylet-driven lead in left bundle branch area pacing: Results from INSIGHT-LBBA. Heart Rhythm. 2025 Feb 4:S1547-5271(25)00111-0. doi: 10.1016/j.hrthm.2025.01.041. Online ahead of print.