Device Related InfectionMHYHNCT04016870
Project My Heart Your Heart: Pacemaker Reuse
A study testing Reconditioned Pacemaker and New Pacemaker in people with Device Related Infection and Device Malfunction, run by University of Michigan at 8 sites in 7 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Device Related Infection, Device Malfunction, Bradycardia
- What is being tested?
- Reconditioned Pacemaker and New Pacemaker
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 370 participants
- Where
- 8 sitesin 7 countries
- Study dates
- 13 Oct 2018to Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
Trial locations and contacts
8 sites in 7 countries.
8 sites in 7 countries
Nigeria2 sites
LASUTH
Ikeja, Lagos, 101233
Port Harcourt Teaching Hospital
Port Harcourt, Rivers State
About this study
Official title: Project My Heart Your Heart: Prospective Evaluation of the Safety and Efficacy of Cardiac Pacemaker Reuse in Low to Middle Income Countries
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.
- Conditions
- Device Related Infection, Device Malfunction, Bradycardia
- Being tested
- Reconditioned Pacemaker, New Pacemaker
- Medical subject headings
- Prosthesis-Related Infections, Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reconditioned PacemakerDevice
Also called St. Jude Medical device, Boston Scientific device, Medtronic device
Devices from the three manufacturers below will be used.
New PacemakerDevice
Also called St. Jude Medical device, Boston Scientific device, Medtronic device, Biotronik device
Devices from the four manufacturers below will be used.
| Study group | Role | What they receive |
|---|---|---|
| New Device | Active comparator | New pacemakers will be sourced from pacemaker manufacturers. Receives: Device: New Pacemaker |
| Reconditioned Device | Experimental | 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. Receives: Device: Reconditioned Pacemaker |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months post device implantation
Secondary outcomes (1)
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.
Measured: 12 months post device implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2019
- Study start13 Oct 2018
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Device Related InfectionStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study will be a randomized, multi-center, single-blinded non-inferiority study of 278 patients (all outside of United States) with Class I indications for pacemaker implantation.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 370 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Crawford, MD, University of Michigan
- Investigators
- Thomas Crawford, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04016870
- Sponsor's protocol ID
- HUM00050238
- Acronym
- MHYH
- Status last verified
- Apr 2025
- First submitted
- 8 Jul 2019
- Last updated
- 4 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project My Heart Your Heart: Prospective Evaluation of the Safety and Efficacy of Cardiac Pacemaker Reuse in Low to Middle Income Countries
- ClinicalTrials.gov ID
- NCT04016870
- Acronym / sponsor ID
- MHYH / HUM00050238
- Conditions
- Device Related Infection, Device Malfunction, Bradycardia
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 370 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 13 Oct 2018 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 12 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study will be a randomized, multi-center, single-blinded non-inferiority study of 278 patients (all outside of United States) with Class I indications for pacemaker implantation.
| Arm | Type | Receives |
|---|---|---|
| New Device | Active comparator | Device: New PacemakerNew pacemakers will be sourced from pacemaker manufacturers. |
| Reconditioned Device | Experimental | Device: Reconditioned PacemakerDonated 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reconditioned PacemakerAlso: St. Jude Medical device, Boston Scientific device, Medtronic deviceDevices from the three manufacturers below will be used. | Device | Reconditioned Device |
| New PacemakerAlso: St. Jude Medical device, Boston Scientific device, Medtronic device, Biotronik deviceDevices from the four manufacturers below will be used. | Device | New Device |
Primary outcome
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
1 secondary outcome
Freedom from Pacemaker Software or Hardware Malfunction at 12 months
Time frame: 12 months post device implantation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Crawford, MD principal investigator
University of Michigan
8 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reconditioned Pacemaker and New Pacemaker in people with Device Related Infection and Device Malfunction, run by University of Michigan at 8 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Nigeria, Kenya, Mexico, Mozambique, Paraguay and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from Procedure-Related Infection at 12 months (time frame: 12 months post device implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2025.