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Device Malfunction clinical trials

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NCT ID: NCT04016870 Enrolling by invitation - Bradycardia Clinical Trials

Project My Heart Your Heart: Pacemaker Reuse

MHYH
Start date: October 13, 2018
Phase: N/A
Study type: Interventional

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.