NCT04016870

Project My Heart Your Heart: Pacemaker Reuse

Project My Heart Your Heart: Prospective Evaluation of the Safety and Efficacy of Cardiac Pacemaker Reuse in Low to Middle Income Countries

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 370 (estimated)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Lack of access to pacemakers is a major challenge to the provision of cardiovascular health care in Low and Middle Income Countries (LMIC). Post-mortem pacemaker utilization could be safe, efficacious, and ethically responsible means of delivering the needed care. Reconditioned pacemakers can provide therapy for patients with symptomatic bradycardia and no means of receiving a new device. The objective of the clinical trial is to determine if pacemaker reutilization can be shown to be a safe means of delivering pacemakers to patients in LMIC without resources. Consented patients in this multi-center trial will be randomized to undergo implantation of either a reconditioned device or a new device.

Conditions

• Device Related Infection
• Device Malfunction
• Bradycardia

Interventions

Type	Name	Description
DEVICE	Reconditioned Pacemaker	Devices from the three manufacturers below will be used.
DEVICE	New Pacemaker	Devices from the four manufacturers below will be used.

Timeline

• Start date: 2018-10-13
• Primary completion: 2026-01-01
• Completion: 2026-01-01
• First posted: 2019-07-12
• Last updated: 2025-07-04

Locations

8 sites across 7 countries: Kenya, Mexico, Mozambique, Nigeria, Paraguay, Sierra Leone, Venezuela

Regulatory

• FDA-regulated device study