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NCT Number: NCT06606288

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Medtronic

Mounds View, Minnesota, 55112, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Bi-ventricular pacing

Device

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

Primary outcomes

  1. 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).

  2. 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

  1. Device-Related Reintervention Rate

    Time frame: 12 months

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

  2. Heart Failure-All-Cause Mortality Composite

    Time frame: 12 months

    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.

  3. All-Cause Mortality Rate

    Time frame: 12 months

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

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Registry information

Acronym: CORE-CPP

Important dates

Study start
2017
Primary completion
2023
Study completion
2030
First posted
Sep 23, 2024
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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