Project My Heart Your Heart: Pacemaker Reuse

Last updated: July 1, 2025
Sponsor: University of Michigan
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Cardiac Disease

Arrhythmia

Low Blood Pressure (Hypotension)

Treatment

Reconditioned Pacemaker

New Pacemaker

Clinical Study ID

NCT04016870
HUM00050238
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Life expectancy ≥ 2 years.

  • Indications for device implantation must be fulfilled per standard of care.Consistent with 2008 American College of Cardiology / American Heart Associationguidelines for device therapy, one of the following class I indications must be met.

  • Sinus Node Dysfunction

  • Acquired Atrioventricular (AV) Block

  • Chronic Bifascicular Block

  • Hypersensitive Carotid Syndrome

  • Lack of financial ability to pay for a new device must be assessed and documented.

  • All other methods of new device acquisition must be exhausted.

  • Patient must be agreeable and able to follow-up with the implanting center within 2weeks for wound check, at 2 months, 6 months, and every 6 months thereafter forroutine pacemaker checks.

Exclusion

Exclusion Criteria:

  • Severe valvular disease

  • Severe pulmonary disease

  • End-stage renal disease (creatinine clearance < 30 mL/min) whether or not ondialysis

  • Evidence of ongoing systemic infection

  • Prior pacemaker or implantable cardioverter-defibrillator implantation

  • Significant contraindication to pacemaker implantation per evaluation of theimplanting physician (very high risk of complications).

  • Presence of any other condition that the local investigator feels would beproblematic or would restrict or limit the participation of the patient for theentire study period

  • Pregnant women

Study Design

Total Participants: 370
Treatment Group(s): 2
Primary Treatment: Reconditioned Pacemaker
Phase:
Study Start date:
October 13, 2018
Estimated Completion Date:
January 31, 2026

Connect with a study center

  • The Moi Teaching and Referral Hospital

    Eldoret,
    Kenya

    Site Not Available

  • Universidad Autonoma de Nuevo Leon

    Monterrey,
    Mexico

    Site Not Available

  • Hospital Central de Maputo

    Maputo,
    Mozambique

    Site Not Available

  • LASUTH

    Ikeja, Lagos 101233
    Nigeria

    Site Not Available

  • Port Harcourt Teaching Hospital

    Port Harcourt, Rivers
    Nigeria

    Site Not Available

  • FUNDACOR

    Asunción,
    Paraguay

    Site Not Available

  • Choithram Memorial Hospital

    Freetown,
    Sierra Leone

    Site Not Available

  • ASCARDIO

    Barquisimeto, Lara 3001
    Venezuela

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.