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

NCT06606288 | Active Not Recruiting FDA Device

• 1 other identifier: 30489333
• Study Type: observational
• Target: 6,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Device-Related Reintervention Rate

  12 months

• Heart Failure-All-Cause Mortality Composite

  12 months

• All-Cause Mortality Rate

  12 months

Study Arms (2)

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

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

Interventions

Conduction system pacing DEVICE

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

Conduction system pacing

Bi-ventricular pacing DEVICE

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

Bi-ventricular pacing

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (1)

Medtronic

Mounds View, Minnesota, 55112, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2024
• First Posted: September 23, 2024
• Study Start: January 1, 2017
• Primary Completion: December 31, 2023
• Study Completion (Estimated): December 31, 2030
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)