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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
370
Devices from the three manufacturers below will be used.
Devices from the four manufacturers below will be used.
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
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
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