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

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 Overview

• Status: Active, not recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Device: Conduction system pacing; Device: Bi-ventricular pacing

• Study Type: Observational
• Enrollment (Estimated): 6000

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Mounds View, Minnesota, United States, 55112
      • Medtronic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The study cohort will include all U.S. Medicare beneficiaries enrolled in fee-for-service Medicare implanted with a Medtronic pacemaker between January 1, 2017 and December 1, 2023.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Device: 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; 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.	Device: Bi-ventricular pacing; Implant with a Medtronic bi-ventricular pacemaker (CRT-P) on or after the study date

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device-Related Reintervention Rate	Compare the device-related reintervention rate associated with dual chamber CSP vs. BVP.	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.	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.	12 months

Collaborators and Investigators

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): December 31, 2023
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: September 18, 2024
• First Submitted That Met QC Criteria: September 18, 2024
• First Posted (Actual): September 23, 2024

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: 30489333

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Sharing individual participant data is not permitted under the data use agreement with the Centers for Medicare and Medicaid Services (CMS) which allows us to access the Medicare data for research purposes.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes