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Project My Heart Your Heart: Pacemaker Reuse

NCT04016870 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 370

Last updated 2025-07-04

No results posted yet for this study

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

DEVICE

Reconditioned Pacemaker

Devices from the three manufacturers below will be used.

DEVICE

New Pacemaker

Devices from the four manufacturers below will be used.

Sponsors & Collaborators

Principal Investigators

  • Thomas Crawford, MD · University of Michigan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-13
Primary Completion
2026-01-31
Completion
2026-01-31
FDA Device
Yes

Countries

  • Kenya
  • Mexico
  • Mozambique
  • Nigeria
  • Paraguay
  • Sierra Leone
  • Venezuela

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04016870 on ClinicalTrials.gov