Characterizing Outcomes and Real-World Experience of Cardiac Physiologic Pacing (The CORE-CPP Study)
Running, not enrolling
Conditions studied: Heart Failure
In brief
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 pacemaker, is a safe and effective alternative to biventricular pacing (BVP) in patients indicated for cardiac resynchronization therapy (CRT) to deliver cardiac physiologic pacing (CPP), as documented in the clinical literature.
Key facts
- Study ID
- NCT06606288
- Run by
- Medtronic Cardiac Rhythm and Heart Failure
- People needed
- 6000
- Starts
- 2017-01-01
- Expected to finish
- 2030-12-31
- Last updated by the study team
- 2026-04-29
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Medtronic — Mounds View, Minnesota, United States
Full record on ClinicalTrials.gov
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