Project My Heart Your Heart: Pacemaker Reuse

NCT04016870 | Active Not Recruiting DMC FDA Device

• 1 other identifier: HUM00050238
• Study Type: interventional
• Target: 370
• Locations: 7 countries
• Sites: 8

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.

Conditions

Device Related Infection; Device Malfunction; Bradycardia

Outcome Measures

Primary Outcomes (1)

• Freedom from Procedure-Related Infection at 12 months

  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

  12 months post device implantation

Secondary Outcomes (1)

• Freedom from Pacemaker Software or Hardware Malfunction at 12 months

  12 months post device implantation

Study Arms (2)

New Device

ACTIVE COMPARATOR

New pacemakers will be sourced from pacemaker manufacturers.

Device: New Pacemaker

Reconditioned Device

EXPERIMENTAL

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.

Device: Reconditioned Pacemaker

Interventions

Reconditioned Pacemaker DEVICE

Devices from the three manufacturers below will be used.

Also known as: St. Jude Medical device, Boston Scientific device, Medtronic device

Reconditioned Device

New Pacemaker DEVICE

Devices from the four manufacturers below will be used.

Also known as: St. Jude Medical device, Boston Scientific device, Medtronic device, Biotronik device

New Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (8)

The Moi Teaching and Referral Hospital

Eldoret, Kenya

Location

Universidad Autonoma de Nuevo Leon

Monterrey, Mexico

Location

Hospital Central de Maputo

Maputo, Mozambique

Location

LASUTH

Ikeja, Lagos, 101233, Nigeria

Location

Port Harcourt Teaching Hospital

Port Harcourt, Rivers State, Nigeria

Location

FUNDACOR

Asunción, Paraguay

Location

Choithram Memorial Hospital

Freetown, Sierra Leone

Location

ASCARDIO

Barquisimeto, Lara, 3001, Venezuela

Location

MeSH Terms

Conditions

Prosthesis-Related Infections; Bradycardia

Condition Hierarchy (Ancestors)

Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases

Study Officials

• Thomas Crawford, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This study will be a randomized, multi-center, single-blinded non-inferiority study of 278 patients (all outside of United States) with Class I indications for pacemaker implantation.

Study Record Dates

• First Submitted: July 8, 2019
• First Posted: July 12, 2019
• Study Start: October 13, 2018
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: July 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

VE (1); MO (1); SI (1); KE (1); PA (1); ME (1); NG (2)