Characterizing Outcomes and Real-World Experience of Cardiac Physiologic Pacing (The CORE-CPP Study) (NCT06606288) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Characterizing Outcomes and Real-World Experience of Cardiac Physiologic Pacing (The CORE-CPP Study)
United States6,000 participantsStarted 2017-01-01
Plain-language 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 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.
Who can participate
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See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
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 Criteria:
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.