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Active Not RecruitingNANCT04016870

Project My Heart Your Heart: Pacemaker Reuse

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...

Lead sponsor: University of Michigan•8 locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

University of Michigan

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

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 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 Criteria

•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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: July 4, 2025Terms

Trial snapshot

StatusACTIVE_NOT_RECRUITING

PhaseNA

Enrollment370

Start dateOct 2018

Last updatedJul 4, 2025

Condition

Device Related Infection Device Malfunction Bradycardia

Locations shown

The Moi Teaching and Referral Hospital

Eldoret

Universidad Autonoma de Nuevo Leon

Monterrey

Hospital Central de Maputo

Maputo

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 4, 2025Data synced to Clareo: May 25, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions