Status:
ACTIVE_NOT_RECRUITING
Project My Heart Your Heart: Pacemaker Reuse
Lead Sponsor:
University of Michigan
Conditions:
Device Related Infection
Device Malfunction
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Severe valvular disease
- Severe pulmonary disease
- End-stage renal disease (creatinine clearance \< 30 mL/min) whether or not on dialysis
- Evidence of ongoing systemic infection
- Prior pacemaker or implantable cardioverter-defibrillator implantation
- Significant contraindication to pacemaker implantation per evaluation of the implanting physician (very high risk of complications).
- 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
- Pregnant women
Key Trial Info
Start Date :
October 13 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
370 Patients enrolled
Trial Details
Trial ID
NCT04016870
Start Date
October 13 2018
End Date
January 1 2026
Last Update
July 4 2025
Active Locations (8)
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1
The Moi Teaching and Referral Hospital
Eldoret, Kenya
2
Universidad Autonoma de Nuevo Leon
Monterrey, Mexico
3
Hospital Central de Maputo
Maputo, Mozambique
4
LASUTH
Ikeja, Lagos, Nigeria, 101233