Project My Heart Your Heart: Pacemaker Reuse

Bradycardia Clinical Trial

— MHYH  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04016870
• Other study ID #: HUM00050238
• Status: Enrolling by invitation
• Phase: N/A
• Start date: October 13, 2018
• Est. completion date: October 2024

Study information

• Verified date: September 2023
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 260
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bradycardia
• Device Malfunction
• Device Related Infection
• Prosthesis-Related Infections

Intervention

Device:
• Reconditioned Pacemaker
Devices from the three manufacturers below will be used.
• New Pacemaker
Devices from the four manufacturers below will be used.

Locations

Country	Name	City	State
Kenya	The Moi Teaching and Referral Hospital	Eldoret
Nigeria	LASUTH	Ikeja	Lagos
Nigeria	Port Harcourt Teaching Hospital	Port Harcourt	Rivers
Paraguay	FUNDACOR	Asunción
Sierra Leone	Choithram Memorial Hospital	Freetown
Venezuela	ASCARDIO	Barquisimeto	Lara

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Countries where clinical trial is conducted

Kenya,  Nigeria,  Paraguay,  Sierra Leone,  Venezuela, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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