Mechanical Circulatory Support Korea Post Market Surveillance Study (PMS)

Medtronic Cardiac Rhythm and Heart Failure77 enrolled

Overview

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).

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

End-stage Heart Failure

Interventions

HeartWare Ventricular Assist DeviceDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (2)

Asan Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Outcomes

Primary Outcomes

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.

Time frame: Implant to 6 months, 24 months

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: Implant up through 24 months

Data from ClinicalTrials.gov

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