Project My Heart Your Heart: Pacemaker Reuse

Overview

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.

Full Title of Study: “Project My Heart Your Heart: Prospective Evaluation of the Safety and Efficacy of Cardiac Pacemaker Reuse in Low to Middle Income Countries”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: October 2022

Interventions

  • Device: Reconditioned Pacemaker
    • Devices from the three manufacturers below will be used.
  • Device: New Pacemaker
    • Devices from the four manufacturers below will be used.

Arms, Groups and Cohorts

  • Active Comparator: New Device
    • New pacemakers will be sourced from pacemaker manufacturers.
  • Experimental: 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.

Clinical Trial Outcome Measures

Primary Measures

  • Freedom from Procedure-Related Infection at 12 months
    • Time Frame: 12 months post device implantation
    • 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

Secondary Measures

  • Freedom from Pacemaker Software or Hardware Malfunction at 12 months
    • Time Frame: 12 months post device implantation
    • Pacemaker software or hardware malfunction include unexpected premature battery depletion, device or electrode malfunction, or unexplained patient death.

Participating in This Clinical Trial

Inclusion Criteria

  • Life expectancy ≥ 2 years. – 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 valvular disease – 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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Michigan
  • Provider of Information About this Clinical Study
    • Principal Investigator: Thomas Crawford, Associate Professor – University of Michigan
  • Overall Official(s)
    • Thomas Crawford, MD, Principal Investigator, University of Michigan

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