Status:
COMPLETED
INGEVITY+ Active Fixation Pace/Sense Lead Clinical Study
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Bradycardia
Eligibility:
All Genders
18+ years
Brief Summary
The objective of this study is it to confirm the safety and effectiveness of the INGEVITY+ Active Fixation Pace/Sense Lead.
Eligibility Criteria
Inclusion
- Subject is willing and capable of providing informed consent
- 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
- Subject meets an indication for a Boston Scientific Pacemaker or CRT-P device per product labeling (Physician's Technical Manual)
- 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
- Age 18 or above, or of legal age to give informed consent specific to state and national law
Exclusion
- Known or suspected sensitivity to dexamethasone acetate (DXA)
- Has a mechanical tricuspid heart valve
- 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)
- Currently requiring hemo- or peritoneal dialysis
- Subject has or has had implanted any pacing or ICD system, including subcutaneous, transvenous or leadless systems
- Intended to receive a single chamber device
- Documented history of permanent or persistent AF
- Currently on an active organ transplant list
- Documented life expectancy of less than 12 months
- Enrolled in any other concurrent study unless prior approval is received from the Sponsor
Key Trial Info
Start Date :
August 6 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2021
Estimated Enrollment :
109 Patients enrolled
Trial Details
Trial ID
NCT04346537
Start Date
August 6 2020
End Date
March 1 2021
Last Update
July 14 2022
Active Locations (13)
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1
Heart Center Research, LLC
Huntsville, Alabama, United States, 35801
2
Arrhythmia Research Group
Jonesboro, Arkansas, United States, 72401
3
Torrance Memorial Medical Center
Torrance, California, United States, 90505
4
Emory University Hospital
Atlanta, Georgia, United States, 30322