Characterizing Outcomes and Real-World Experience of Cardiac Physiologic Pacing (The CORE-CPP Study)
- Conditions
- Heart Failure
- Interventions
- Device: Conduction system pacingDevice: Bi-ventricular pacing
- Registration Number
- NCT06606288
- Lead Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 6000
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.
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Conduction system pacing Conduction system pacing Medicare beneficiaries indicated for CRT implanted with a Medtronic dual-chamber transvenous pacemaker on or after the study start date with lead type and placement data indicating conduction system pacing. Bi-ventricular pacing Bi-ventricular pacing Medicare beneficiaries indicated for CRT implanted with a Medtronic bi-ventricular pacemaker (CRT-P) on or after the study start date with lead type and placement data not indicating conduction system pacing.
- Primary Outcome Measures
Name Time Method Acute complication rate 30 days Demonstrate that dual-chamber CSP is non-inferior to BVP on implant safety in patients indicated for CRT.
Endpoint: Compare the acute (≤ 30 days) overall complication rate associated with dual chamber CSP vs. BVP. The acute overall complication rate is a composite measure of separate elements of complications (embolism and thrombosis, events at puncture site, cardiac effusion and perforation, device-related complications, and other procedural complications) and reinterventions (lead-related reinterventions, device revisions, replacements, removals, and upgrades to CRT).Heart Failure Hospitalization Rate 12 months Demonstrate that dual-chamber CSP is non-inferior to BVP in patients indicated for CRT.
Endpoint: Compare the heart failure hospitalization rate associated with CSP vs. BVP in the CRT-indicated population.
- Secondary Outcome Measures
Name Time Method Device-Related Reintervention Rate 12 months Compare the device-related reintervention rate associated with dual chamber CSP vs. BVP.
Heart Failure-All-Cause Mortality Composite 12 months Compare the composite endpoint of heart failure hospitalization or all-cause mortality rate associated with dual=chamber CSP use vs. BVP in the CRT-indicated population.
All-Cause Mortality Rate 12 months Compare the all-cause mortality rate associated with dual-chamber CSP use vs. BVP in the CRT-indicated population.
Trial Locations
- Locations (1)
Medtronic
🇺🇸Mounds View, Minnesota, United States