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

Medtronic

Status: Active, not recruiting

Conditions: Heart Failure

Treatments: Device: Bi-ventricular pacing; Device: Conduction system pacing

Study type: Observational

Funder types: Industry

Identifiers

NCT06606288

30489333

Details and patient eligibility

About

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.

Enrollment: 6,000 estimated patients

Sex: All

Volunteers: No 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.

Trial design

6,000 participants in 2 patient groups

Conduction system pacing

Description:

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.

Treatment:

Device: Conduction system pacing

Bi-ventricular pacing

Description:

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.

Treatment:

Device: Bi-ventricular pacing