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| Name | Class |
|---|---|
| Boston Scientific Corporation | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LBBA INGEVITY+ Pacing | Patients indicated for anti-bradycardia pacing that have been implanted with an INGEVITY+ lead in the LBBA. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiac pacing | Device | Patient's previously implanted with the INGEVITY+ lead located in the LBBA |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lead-Related Complication Free Rate | Adverse events that require correction with an invasive intervention or resulted in significant loss of device functionality. | Implant through 90 days |
| Pacing Threshold | Percent of INGEVITY+ leads with pacing capture threshold measurement of less than or equal to 2V. | Implant through 90 days |
| Sensed R-wave amplitude | Percent of INGEVITY+ leads with an R-wave amplitude greater than 5mV. | Implant through 90 days |
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Inclusion Criteria for Primary Analysis:
Exclusion Criteria for Primary Analysis:
-ICD and CRT-D devices
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Patients implanted with an INGEVITY+ lead implanted in the LBBA to provide rate support for bradycardia.
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Friedman, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sarasota Memorial Health Care System | Sarasota | Florida | 34233 | United States | ||
| University of Chicago |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39914662 | Result | 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 Aug;22(8):2047-2054. doi: 10.1016/j.hrthm.2025.01.041. Epub 2025 Feb 4. |
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| ID | Term |
|---|---|
| D001919 | Bradycardia |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| Chicago |
| Illinois |
| 60637 |
| United States |
| Community Heart And Vascular Hospital | Indianapolis | Indiana | 46227 | United States |
| Essentia Health - Saint Mary's Duluth Clinic | Duluth | Minnesota | 55805 | United States |
| NewYork-Presbyterian Queens | Flushing | New York | 11355 | United States |
| Duke University | Durham | North Carolina | 27708 | United States |
| TriHealth Bethesda North Hospital | Cincinnati | Ohio | 45242 | United States |
| Houston Methodist Sugar Land Hospital | Sugar Land | Texas | 77479 | United States |
| D013568 |
| Pathological Conditions, Signs and Symptoms |