Project My Heart Your Heart: Pacemaker Reuse (MHYH)

Project My Heart Your Heart: Prospective Evaluation of the Safety and Efficacy of Cardiac Pacemaker Reuse in Low to Middle Income Countries

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Bradycardia; Device Related Infection; Device Malfunction
• Intervention / Treatment: Device: New Pacemaker; Device: Reconditioned Pacemaker

• Study Type: Interventional
• Enrollment (Estimated): 260
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Kenya
  • Eldoret, Kenya
    • The Moi Teaching and Referral Hospital
• Nigeria
  • Lagos
    • Ikeja, Lagos, Nigeria, 101233
      • LASUTH
  • Rivers
    • Port Harcourt, Rivers, Nigeria
      • Port Harcourt Teaching Hospital
• Paraguay
  • Asunción, Paraguay
    • FUNDACOR
• Sierra Leone
  • Freetown, Sierra Leone
    • Choithram Memorial Hospital
• Venezuela
  • Lara
    • Barquisimeto, Lara, Venezuela, 3001
      • ASCARDIO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: New Device; New pacemakers will be sourced from pacemaker manufacturers.	Device: New Pacemaker; Devices from the four manufacturers below will be used.; Other Names: St. Jude Medical device; Boston Scientific device; Medtronic device; Biotronik device
Experimental: Reconditioned Device; 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; Devices from the three manufacturers below will be used.; Other Names: St. Jude Medical device; Boston Scientific device; Medtronic device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Thomas Crawford, MD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2018
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: July 8, 2019
• First Submitted That Met QC Criteria: July 8, 2019
• First Posted (Actual): July 12, 2019

Study Record Updates

• Last Update Posted (Actual): October 2, 2023
• Last Update Submitted That Met QC Criteria: September 28, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Infections; Postoperative Complications; Arrhythmias, Cardiac; Bradycardia; Prosthesis-Related Infections
• Other Study ID Numbers: HUM00050238

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes