Project My Heart Your Heart: Pacemaker Reuse

Study Overview
=================
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.

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

Conditions
-----------------
Device Related Infection, Device Malfunction, Bradycardia

Intervention / Treatment
-----------------
* Device: Reconditioned Pacemaker
* Device: New Pacemaker


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: New Device<br>New pacemakers will be sourced from pacemaker manufacturers. | Device: New Pacemaker<br>* Devices from the four manufacturers below will be used.<br>* Other names: Biotronik device;|
| Experimental: Reconditioned Device<br>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<br>* Devices from the three manufacturers below will be used.<br>* Other names: Medtronic device;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |