INGEVITY+ Active Fixation Pace/Sense Lead Clinical Study

Boston Scientific

Status: Completed

Conditions: Bradycardia

Treatments: Device: INGEVITY+™ Pace/Sense Lead

Study type: Observational

Funder types: Industry

Identifiers

NCT04346537

92424682

Details and patient eligibility

About

The objective of this study is it to confirm the safety and effectiveness of the INGEVITY+ Active Fixation Pace/Sense Lead.

Enrollment: 109 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subject is willing and capable of providing informed consent
2. Subject is intended to undergo initial (de novo) pacing system implant using INGEVITY+ Leads in the Right Atrium (RA) and Right Ventricle (RV) and a Boston Scientific pulse generator
3. Subject meets an indication for a Boston Scientific Pacemaker or CRT-P device per product labeling (Physician's Technical Manual)
4. Willing and capable of participating in all testing/visits associated with this clinical study at an approved clinical study center and at the intervals defined by this protocol
5. Age 18 or above, or of legal age to give informed consent specific to state and national law

Exclusion criteria

1. Known or suspected sensitivity to dexamethasone acetate (DXA)
2. Has a mechanical tricuspid heart valve
3. Women of childbearing potential who are or might be pregnant at the time of study enrollment or INGEVITY+ Lead implant (method of assessment upon physician's discretion)
4. Currently requiring hemo- or peritoneal dialysis
5. Subject has or has had implanted any pacing or ICD system, including subcutaneous, transvenous or leadless systems
6. Intended to receive a single chamber device
7. Documented history of permanent or persistent AF
8. Currently on an active organ transplant list
9. Documented life expectancy of less than 12 months
10. Enrolled in any other concurrent study unless prior approval is received from the Sponsor

Trial design