Characterizing Outcomes and Real-World Experience of Cardiac Physiologic Pacing (The CORE-CPP Study)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Enrollment
- 6000
- Locations
- 1
- Primary Endpoint
- Acute complication rate
- Status
- Active, Not Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
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).
Outcomes
Primary Outcomes
Acute complication rate
Time Frame: 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
Time Frame: 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 Outcomes
- Device-Related Reintervention Rate(12 months)
- Heart Failure-All-Cause Mortality Composite(12 months)
- All-Cause Mortality Rate(12 months)