Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
370 participants
INTERVENTIONAL
2018-10-13
2026-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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New Device
New pacemakers will be sourced from pacemaker manufacturers.
New Pacemaker
Devices from the four manufacturers below will be used.
Reconditioned Device
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.
Reconditioned Pacemaker
Devices from the three manufacturers below will be used.
Interventions
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Reconditioned Pacemaker
Devices from the three manufacturers below will be used.
New Pacemaker
Devices from the four manufacturers below will be used.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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University of Michigan
OTHER
Responsible Party
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Thomas Crawford, MD
Associate Professor
Principal Investigators
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Thomas Crawford, MD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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The Moi Teaching and Referral Hospital
Eldoret, , Kenya
Universidad Autonoma de Nuevo Leon
Monterrey, , Mexico
Hospital Central de Maputo
Maputo, , Mozambique
LASUTH
Ikeja, Lagos, Nigeria
Port Harcourt Teaching Hospital
Port Harcourt, Rivers State, Nigeria
FUNDACOR
Asunción, , Paraguay
Choithram Memorial Hospital
Freetown, , Sierra Leone
ASCARDIO
Barquisimeto, Lara, Venezuela
Countries
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Other Identifiers
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HUM00050238
Identifier Type: -
Identifier Source: org_study_id
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