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Active, Not Recruiting

NCT Number: NCT04016870

Project My Heart Your Heart: Pacemaker Reuse

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Moi Teaching and Referral Hospital, Eldoret, Kenya

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Reconditioned Pacemaker

Device

Devices from the three manufacturers below will be used.

Other names: St. Jude Medical device, Boston Scientific device, Medtronic device

New Pacemaker

Device

Devices from the four manufacturers below will be used.

Other names: St. Jude Medical device, Boston Scientific device, Medtronic device, Biotronik device

Primary outcomes

  1. Freedom from Procedure-Related Infection at 12 months

    Time frame: 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 outcomes

  1. Freedom from Pacemaker Software or Hardware Malfunction at 12 months

    Time frame: 12 months post device implantation

    Pacemaker software or hardware malfunction include unexpected premature battery depletion, device or electrode malfunction, or unexplained patient death.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

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

Acronym: MHYH

Important dates

Study start
2018
Primary completion
2026
Study completion
2026
First posted
Jul 12, 2019
Registry last updated
Jul 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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