NCT06606288

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 6,000 (estimated)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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
DEVICE	Bi-ventricular pacing	Implant with a Medtronic bi-ventricular pacemaker (CRT-P) on or after the study date

Timeline

• Start date: 2017-01-01
• Primary completion: 2023-12-31
• Completion: 2030-12-31
• First posted: 2024-09-23
• Last updated: 2025-03-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study