Clinical trial NCT04016870: Project My Heart Your Heart: Pacemaker Reuse
Official title: Project My Heart Your Heart: Prospective Evaluation of the Safety and Efficacy of Cardiac Pacemaker Reuse in Low to Middle Income Countries
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Device Related Infection
Device Malfunction
Bradycardia
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2019-07-12
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study will be a randomized, multi-center, single-blinded non-inferiority study of 260 patients (all outside of United States) with Class I indications for pacemaker implantation.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 outcomes:
measure: Freedom from Procedure-Related Infection at 12 months
timeFrame: 12 months post device implantation
Secondary outcomes:
measure: Freedom from Pacemaker Software or Hardware Malfunction at 12 months
timeFrame: 12 months post device implantation
Other outcomes:
Locations:
city: Eldoret
country: Kenya
facility: The Moi Teaching and Referral Hospital
city: Monterrey
country: Mexico
facility: Universidad Autonoma de Nuevo Leon
city: Maputo
country: Mozambique
facility: Hospital Central de Maputo
city: Ikeja
country: Nigeria
facility: LASUTH
state: Lagos
city: Port Harcourt
country: Nigeria
facility: Port Harcourt Teaching Hospital
state: Rivers
city: Asunción
country: Paraguay
facility: FUNDACOR
city: Freetown
country: Sierra Leone
facility: Choithram Memorial Hospital
city: Barquisimeto
country: Venezuela
facility: ASCARDIO
state: Lara
Study officials:
affiliation: University of Michigan
name: Thomas Crawford, MD
role: PRINCIPAL_INVESTIGATOR
References: