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

NCT06606288 · tracked via the Priya Life Science USA tracker

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

Phase

Observational

Started

2017-01-01

Last updated

2026-04-29

Condition(s) studied

Heart Failure

Investigational drug(s) / intervention(s)

Conduction system pacingBi-ventricular pacing

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

Study 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.

Eligibility

Sex

ALL

Min age

—

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

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.

Trial sites (1)

Facility	City	Region	Status
Medtronic	Mounds View	Minnesota

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06606288 on ClinicalTrials.gov ↗ ← All trials in the USA