NCT04016870Active, not recruiting
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
Source: ClinicalTrials.gov · Last updated 4 Jul 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 370 (estimated)
- First submitted
- 8 Jul 2019
- Start date
- 13 Oct 2018
- Primary completion date
- Jan 2026
- Lead sponsor
- University of Michigan
- NCT number
- NCT04016870
What you commit to
- Study type: Interventional
- Planned participants: 370
- From 13 Oct 2018 to the primary completion date, Jan 2026
- 8 sites in 7 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior pacemaker or implantable cardioverter-defibrillator implantation
Other illness
- Severe valvular disease
- Severe pulmonary disease
- Evidence of ongoing systemic infection
- Presence of any other condition that the local investigator feels would be problematic or would restrict or limit the participation of the patient for the entire study period
Lab values
- End-stage renal disease (creatinine clearance \< 30 mL/min) whether or not on dialysis
Other
- Significant contraindication to pacemaker implantation per evaluation of the implanting physician (very high risk of complications).
- Pregnant women
Who the study is looking for
- Life expectancy ≥ 2 years.
- Indications for device implantation must be fulfilled per standard of care. Consistent with 2008 American College of Cardiology / American Heart Association guidelines 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 2 weeks for wound check, at 2 months, 6 months, and every 6 months thereafter for routine pacemaker checks.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Moi Teaching and Referral Hospital Coordinator of this site? Confirm its status | Eldoret | Kenya | Unknown status |
| Universidad Autonoma de Nuevo Leon Coordinator of this site? Confirm its status | Monterrey | Mexico | Unknown status |
| Hospital Central de Maputo Coordinator of this site? Confirm its status | Maputo | Mozambique | Unknown status |
| LASUTH Coordinator of this site? Confirm its status | Ikeja | Nigeria | Unknown status |
| Port Harcourt Teaching Hospital Coordinator of this site? Confirm its status | Port Harcourt | Nigeria | Unknown status |
| FUNDACOR Coordinator of this site? Confirm its status | Asunción | Paraguay | Unknown status |
| Choithram Memorial Hospital Coordinator of this site? Confirm its status | Freetown | Sierra Leone | Unknown status |
| ASCARDIO Coordinator of this site? Confirm its status | Barquisimeto | Venezuela | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.