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Project My Heart Your Heart: Pacemaker Reuse | Clinical Trials | Clareo Health

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Project My Heart Your Heart: Pacemaker Reuse

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

NCT04016870•University of Michigan

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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

Locations (8)

The Moi Teaching and Referral Hospital

Eldoret, Kenya

Universidad Autonoma de Nuevo Leon

Monterrey, Mexico

Hospital Central de Maputo

Maputo, Mozambique

LASUTH

Ikeja, Lagos, Nigeria

Port Harcourt Teaching Hospital

Port Harcourt, Rivers State, Nigeria

FUNDACOR

Asunción, Paraguay

Choithram Memorial Hospital

Freetown, Sierra Leone

ASCARDIO

Barquisimeto, Lara, Venezuela

Key Dates

Start Date

October 13, 2018

Primary Completion Date

January 1, 2026

Completion Date

January 1, 2026

Last Updated

July 4, 2025

Enrollment

370

ESTIMATED participants

Conditions

Device Related InfectionDevice MalfunctionBradycardia

Interventions

Reconditioned Pacemaker

DEVICE

New Pacemaker

DEVICE

Comparison of Supra vs Infra Inguinal Fascia Iliaca Blocks for Spinal Positioning and Analgesia in Lower Limb Surgery

NCT07221682

Post Operative AnalgesiaBradycardia+1 more

View study

RECRUITING

His Bundle Pacing in Bradycardia and Heart Failure

NCT03008291

BradycardiaHeart Failure

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 4, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Project My Heart Your Heart: Pacemaker Reuse

Inclusion Criteria

Exclusion Criteria

Comparison of Supra vs Infra Inguinal Fascia Iliaca Blocks for Spinal Positioning and Analgesia in Lower Limb Surgery

His Bundle Pacing in Bradycardia and Heart Failure

Comparative Analysis Of Dexmedetomidine And Dexamethasone As An Adjuvant To 0.5%Ropivacaine On Onset Of Ultrasound Guided Supraclavicular Brachial Plexus Block In Patients Undergoing Upper Limb Surgeries

Left Bundle Branch Area Pacing (LBBAP) Monitoring Assistant: Evaluation of Portable ECG Solution

"Physiological vs Right Ventricular Pacing Outcome Trial Evaluated for bradyCardia Treatment" (PROTECT-HF)

Comparison of EOSP Between Usg Guided S-FICB vs USG Guided PENG Block in Pts Undergoing Femur Fracture Surgery