Characterizing Outcomes and Real-World Experience of Cardiac Physiologic Pacing (The CORE-CPP Study)

N/AActive Not RecruitingNCT06606288

Medtronic Cardiac Rhythm and Heart Failure6,000 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

6,000

Conditions

Heart Failure

Interventions

Conduction system pacingDEVICE

Implant with a Medtronic dual-chamber transvenous pacemaker on or after the study data with lead type and placement data indicating conduction system pacing

Bi-ventricular pacingDEVICE

Implant with a Medtronic bi-ventricular pacemaker (CRT-P) on or after the study date

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (1)

Medtronic

Mounds View, Minnesota, United States

Outcomes

Primary Outcomes

Acute complication rate

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).

Time frame: 30 days

Heart Failure Hospitalization Rate

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.

Time frame: 12 months

Secondary Outcomes

Device-Related Reintervention Rate

Compare the device-related reintervention rate associated with dual chamber CSP vs. BVP.

Time frame: 12 months

Heart Failure-All-Cause Mortality Composite

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.

Time frame: 12 months

All-Cause Mortality Rate

Compare the all-cause mortality rate associated with dual-chamber CSP use vs. BVP in the CRT-indicated population.

Time frame: 12 months

Data from ClinicalTrials.gov

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