Project My Heart Your Heart: Pacemaker Reuse

Not Applicable

Brief Summary: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
New Device	New Pacemaker	New pacemakers will be sourced from pacemaker manufacturers.
Reconditioned Device	Reconditioned Pacemaker	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.

Primary Outcome Measures

Name	Time	Method
Freedom from Procedure-Related Infection at 12 months	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 Outcome Measures

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

Locations (8): Universidad Autonoma de Nuevo Leon
🇲🇽
Monterrey, Mexico
Hospital Central de Maputo
🇲🇿
Maputo, Mozambique
The Moi Teaching and Referral Hospital
🇰🇪
Eldoret, Kenya
LASUTH
🇳🇬
Ikeja, Lagos, Nigeria
Port Harcourt Teaching Hospital
🇳🇬
Port Harcourt, Rivers, Nigeria
FUNDACOR
🇵🇾
Asunción, Paraguay
Choithram Memorial Hospital
🇸🇱
Freetown, Sierra Leone
ASCARDIO
🇻🇪
Barquisimeto, Lara, Venezuela