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Project My Heart Your Heart: Pacemaker Reuse (MHYH)

Primary Purpose

Device Related Infection, Device Malfunction, Bradycardia

Status
Enrolling by invitation
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Reconditioned Pacemaker
New Pacemaker
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Device Related Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Moi Teaching and Referral Hospital
  • LASUTH
  • Port Harcourt Teaching Hospital
  • FUNDACOR
  • Choithram Memorial Hospital
  • ASCARDIO

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

New Device

Reconditioned Device

Arm Description

New pacemakers will be sourced from pacemaker manufacturers.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
July 8, 2019
Last Updated
September 28, 2023
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT04016870
Brief Title
Project My Heart Your Heart: Pacemaker Reuse
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
October 13, 2018 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Device Related Infection, Device Malfunction, Bradycardia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Allocation
Randomized
Enrollment
260 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
New Device
Arm Type
Active Comparator
Arm Description
New pacemakers will be sourced from pacemaker manufacturers.
Arm Title
Reconditioned Device
Arm Type
Experimental
Arm Description
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 Type
Device
Intervention Name(s)
Reconditioned Pacemaker
Other Intervention Name(s)
St. Jude Medical device, Boston Scientific device, Medtronic device
Intervention Description
Devices from the three manufacturers below will be used.
Intervention Type
Device
Intervention Name(s)
New Pacemaker
Other Intervention Name(s)
St. Jude Medical device, Boston Scientific device, Medtronic device, Biotronik device
Intervention Description
Devices from the four manufacturers below will be used.
Primary Outcome Measure Information:
Title
Freedom from Procedure-Related Infection at 12 months
Description
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
Time Frame
12 months post device implantation
Secondary Outcome Measure Information:
Title
Freedom from Pacemaker Software or Hardware Malfunction at 12 months
Description
Pacemaker software or hardware malfunction include unexpected premature battery depletion, device or electrode malfunction, or unexplained patient death.
Time Frame
12 months post device implantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Crawford, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Moi Teaching and Referral Hospital
City
Eldoret
Country
Kenya
Facility Name
LASUTH
City
Ikeja
State/Province
Lagos
ZIP/Postal Code
101233
Country
Nigeria
Facility Name
Port Harcourt Teaching Hospital
City
Port Harcourt
State/Province
Rivers
Country
Nigeria
Facility Name
FUNDACOR
City
Asunción
Country
Paraguay
Facility Name
Choithram Memorial Hospital
City
Freetown
Country
Sierra Leone
Facility Name
ASCARDIO
City
Barquisimeto
State/Province
Lara
ZIP/Postal Code
3001
Country
Venezuela

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Project My Heart Your Heart: Pacemaker Reuse

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