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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04016870
Other study ID # HUM00050238
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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