Mechanical Circulatory Support Korea Post Market Surveillance Study (PMS)

Study Overview
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Brief Summary
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Medtronic is sponsoring this Mechanical Circulatory Support (MCS) Korea Post-Market Surveillance (PMS) to evaluate the safety and performance of the HeartWare Ventricular Assist Device System (HVAD® System) when used in routine clinical care practice in Korea. The MCS Korea PMS is conducted within Medtronic's Product Surveillance Platform (PSR).

Detailed Description
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The MCS Korea PMS is an observational study conducted at two sites. This MCS Korea PMS is required by the Ministry of Food and Drug Safety (MFDS) as a condition of product approval according to Regulation on Medical Device Re-examination. The designated re-examination period is seven years after the approval date (06 Dec 2013   05 Dec 2020). All patients who require treatment of a commercially available HVAD System for approved indications between the designated re-examination period at a participating PSR site are eligible for enrollment. All enrolled patients will be followed until patient death, transplant, explant (where applicable), or the end of the study, on 05 Dec 2020.

Official Title
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Mechanical Circulatory Support Korea Post Market Surveillance Study (MCS Korea PMS)

Conditions
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End-stage Heart Failure

Intervention / Treatment
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* Device: HeartWare Ventricular Assist Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements Patient has or is intended to receive or be treated with an eligible product Patient is consented within the enrollment window or waiver of consent is approved Exclusion Criteria: Patient who is, or is expected to be inaccessible for follow-up Patient with exclusion criteria required by local law Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results (i.e. no required intervention that could affect interpretation of all-around product safety and or effectiveness)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients implanted with HVAD System<br>Patients who require treatment with HVAD for use as bridge to cardiac transplantation (BTT) or destination therapy (DT) within the re-examination period are eligible for enrollment into the MCS Korea PMS. Patient consent may be obtained prior to HVAD implant or after receiving HVAD implant. Waiver of consent may be allowed if allowed by site's Institutional Review Board (IRB) or Ethics Committee (EC). | Device: HeartWare Ventricular Assist Device<br>* The Medtronic HVAD® System is comprised of three major components: the HVAD Pump with inflow and outflow conduits, a Controller and power sources. In addition to these components, the system includes a Monitor, Battery Charger, AC and DC power adapters, and a Carrying Case. The HVAD® System is indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a bridge to cardiac transplantation (BTT), myocardial recovery, or as destination therapy (DT) in patients for whom subsequent transplantation is not planned.<br>* Other names: HVAD;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival rate up to 6 months and 24 months post-implant | Success (or survival) will be defined as survival, heart transplantation, or explantation for recovery at 6 months post-implant for BTT patients, survival at 24 months post-implant for DT patients. | Implant to 6 months, 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life, as measured by the Minnesota Living with Heart Failure Questionnaire (MLHFQ), up to 24 months post-implant | Characterize changes in quality of life over time | Implant up through 24 months | 
| Functional status, as measured by the New York Heart Association (NYHA) classification, up to 24 months post-implant | Characterize changes in NYHA class over time | Implant up through 24 months | 
| Functional status, as measured by the 6-minute walk test, up to 24 months post-implant | Characterize changes in 6-min walk test results (walked distance in meters) over time | Implant up through 24 months |