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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| New Device | Active Comparator | New pacemakers will be sourced from pacemaker manufacturers. |
|
| Reconditioned Device | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reconditioned Pacemaker | Device | Devices from the three manufacturers below will be used. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 months post device implantation |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months post device implantation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Crawford, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Moi Teaching and Referral Hospital | Eldoret | Kenya | ||||
| Universidad Autonoma de Nuevo Leon |
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| ID | Term |
|---|---|
| D016459 | Prosthesis-Related Infections |
| D001919 | Bradycardia |
| ID | Term |
|---|---|
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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This study will be a randomized, multi-center, single-blinded non-inferiority study of 278 patients (all outside of United States) with Class I indications for pacemaker implantation.
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| New Pacemaker | Device | Devices from the four manufacturers below will be used. |
|
|
| Monterrey |
| Mexico |
| Hospital Central de Maputo | Maputo | Mozambique |
| LASUTH | Ikeja | Lagos | 101233 | Nigeria |
| Port Harcourt Teaching Hospital | Port Harcourt | Rivers State | Nigeria |
| FUNDACOR | Asunción | Paraguay |
| Choithram Memorial Hospital | Freetown | Sierra Leone |
| ASCARDIO | Barquisimeto | Lara | 3001 | Venezuela |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |