Project My Heart Your Heart: Pacemaker Reuse (MHYH)

University of Michigan

Status: Invitation-only

Conditions: Bradycardia; Device Related Infection; Device Malfunction

Treatments: Device: Reconditioned Pacemaker; Device: New Pacemaker

Study type: Interventional

Funder types: Other

Identifiers

NCT04016870

HUM00050238

Details and patient eligibility

About

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.

Enrollment: 320 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

320 participants in 2 patient groups

New Device

Active Comparator group

Description:

New pacemakers will be sourced from pacemaker manufacturers.

Treatment:

Device: New Pacemaker

Reconditioned Device

Experimental group

Description:

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.

Treatment:

Device: Reconditioned Pacemaker