Status:
ACTIVE_NOT_RECRUITING
Characterizing Outcomes and Real-World Experience of Cardiac Physiologic Pacing (The CORE-CPP Study)
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Conditions:
Heart Failure
Eligibility:
All Genders
Brief Summary
The purpose of this study is to use real-world evidence to validate that conduction system pacing (CSP), delivered via a Medtronic 3830 catheter-delivered lead and a Medtronic dual-chamber transvenous...
Eligibility Criteria
Inclusion
- Dual-chamber CSP cohort:
- Medicare beneficiaries implanted with a Medtronic dual-chamber transvenous pacemaker on or after the study start date.
- Lead type and placement data indicating CSP.
- An indication for CRT.
- BVP comparator cohort:
- Medicare beneficiaries implanted with a Medtronic biventricular pacemaker (CRT-P) on or after the study start date.
Exclusion
- Dual-chamber CSP cohort:
- Evidence of a prior CIED device.
- Less than 12 months continuous enrollment in Medicare Part A and Part B prior to implant date.
- Non-Medtronic pacemaker (unable to link to Medtronic device registration data).
- Missing lead type or placement data.
- Lead type and placement data indicating non-CSP placement.
- BVP comparator cohort:
- Evidence of a prior CIED device.
- Less than 12 months continuous enrollment in Medicare Part A and Part B prior to implant date.
- Non-Medtronic pacemaker (unable to link to Medtronic device registration data).
- Missing lead type or placement data.
Key Trial Info
Start Date :
January 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2030
Estimated Enrollment :
6000 Patients enrolled
Trial Details
Trial ID
NCT06606288
Start Date
January 1 2017
End Date
December 31 2030
Last Update
March 26 2025
Active Locations (1)
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1
Medtronic
Mounds View, Minnesota, United States, 55112