Device Related InfectionDevice MalfunctionBradycardia
Investigational drug(s) / intervention(s)
Reconditioned PacemakerNew Pacemaker
Reconditioned Pacemaker: Devices from the three manufacturers below will be used.
New Pacemaker: Devices from the four manufacturers below will be used.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
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
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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