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出境医 / 临床实验 / Project My Heart Your Heart: Pacemaker Reuse (MHYH)

Project My Heart Your Heart: Pacemaker Reuse (MHYH)

Study Description
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.

Condition or disease Intervention/treatment Phase
Device Related Infection Device Malfunction Bradycardia Device: Reconditioned Pacemaker Device: New Pacemaker Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This study will be a randomized, multi-center, single-blinded non-inferiority study of 260 patients (all outside of United States) with Class I indications for pacemaker implantation.
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Project My Heart Your Heart: Prospective Evaluation of the Safety and Efficacy of Cardiac Pacemaker Reuse in Low to Middle Income Countries
Actual Study Start Date : October 13, 2018
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : October 2022
Arms and Interventions
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
Outcome Measures
Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Locations
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Sierra Leone
Choithram Memorial Hospital
Freetown, Sierra Leone
Sponsors and Collaborators
University of Michigan
Investigators
Layout table for investigator information
Principal Investigator: Thomas Crawford, MD University of Michigan
Tracking Information
First Submitted Date  ICMJE July 8, 2019
First Posted Date  ICMJE July 12, 2019
Last Update Posted Date July 20, 2020
Actual Study Start Date  ICMJE October 13, 2018
Estimated Primary Completion Date October 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 8, 2019) 		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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 8, 2019) 		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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Project My Heart Your Heart: Pacemaker Reuse
Official Title  ICMJE Project My Heart Your Heart: Prospective Evaluation of the Safety and Efficacy of Cardiac Pacemaker Reuse in Low to Middle Income Countries
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
This study will be a randomized, multi-center, single-blinded non-inferiority study of 260 patients (all outside of United States) with Class I indications for pacemaker implantation.
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Device Related Infection
  • Device Malfunction
  • Bradycardia
Intervention  ICMJE
  • Device: Reconditioned Pacemaker
    Devices from the three manufacturers below will be used.
    Other Names:
    • St. Jude Medical device
    • Boston Scientific device
    • Medtronic device
  • 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
Study Arms  ICMJE
  • Active Comparator: New Device
    New pacemakers will be sourced from pacemaker manufacturers.
    Intervention: Device: New Pacemaker
  • 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.
    Intervention: Device: Reconditioned Pacemaker
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: July 8, 2019) 		260
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2022
Estimated Primary Completion Date October 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sierra Leone
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04016870
Other Study ID Numbers  ICMJE HUM00050238
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Thomas Crawford, University of Michigan
Study Sponsor  ICMJE University of Michigan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Thomas Crawford, MD University of Michigan
PRS Account University of Michigan
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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