Conduction System Pacing With INGEVITY+

Duke University1,383 enrolled

Overview

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

Conditions

Bradycardia

Interventions

Cardiac pacingDEVICE

Patient's previously implanted with the INGEVITY+ lead located in the LBBA

Eligibility

Sex: ALLMin age: 1 Day

Medical Language ↔ Plain English

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

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

Essentia Health - Saint Mary's Duluth Clinic

Duluth, Minnesota, United States

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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