An interventional study of Reconditioned Pacemaker and New Pacemaker in Device Related Infection, Device Malfunction and Bradycardia, sponsored by University of Michigan. Active, not recruiting at 8 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-04.
Sponsored by University of Michigan · Not applicable, Interventional, and Treatment
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.
35 studies on the registry are indexed under Prosthesis-Related Infections; 10 are open to participants now.
This study's planned enrollment of 370 is above the median of 193 across 20 interventional studies indexed under Prosthesis-Related Infections.
Browse Prosthesis-Related Infections studies →University of Michigan is the lead sponsor of 1,506 studies on the registry; 192 are open to participants now.
Of its 169 completed or terminated interventional studies of FDA-regulated products, 133 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
New pacemakers will be sourced from pacemaker manufacturers.
Device: New Pacemaker
Donated devices are inspected according to specific protocols that evaluate physical and electrical (battery longevity) suitability for future use. Devices deemed to be acceptable are shipped to a third-party vendor (NEScientific) for disassembly, cleaning and re-sterilization.
Device: Reconditioned Pacemaker
Devices from the three manufacturers below will be used.
Also known as: St. Jude Medical device, Boston Scientific device, Medtronic device
Devices from the four manufacturers below will be used.
Also known as: St. Jude Medical device, Boston Scientific device, Medtronic device, Biotronik device
Freedom from Procedure-Related Infection at 12 months
Clinical evidence of pacemaker infection includes local signs of inflammation at the generator site such as erythema, warmth, fluctuance, tenderness, purulent drainage, wound dehiscence, or erosion. Device related endocarditis will be reported if the Duke criteria for infective endocarditis are met. Procedure-related infections will be classified as follows: pocket infection, endocarditis, recurrent bacteremia, extrusion of wires or generator
Time frame: 12 months post device implantation
Freedom from Pacemaker Software or Hardware Malfunction at 12 months
Pacemaker software or hardware malfunction include unexpected premature battery depletion, device or electrode malfunction, or unexplained patient death.
Time frame: 12 months post device implantation
Plan to share: No
No publications or documents are linked to this record.
Started Oct 2018 (actual). Primary completion is estimated for Jan 2026, 87 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Prosthesis-Related Infections →