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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04543747
Other study ID # MCS Korea PMS
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 11, 2015
Est. completion date December 5, 2020

Study information

Verified date June 2021
Source Medtronic Cardiac Rhythm and Heart Failure
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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).


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 77
Est. completion date December 5, 2020
Est. primary completion date December 5, 2020
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Device:
HeartWare Ventricular Assist Device
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.

Locations

Country Name City State
Korea, Republic of Asan Medical Center Seoul
Korea, Republic of Samsung Medical Center Seoul

Sponsors (1)

Lead Sponsor Collaborator
Medtronic Cardiac Rhythm and Heart Failure

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Other INTERMACS-defined Adverse Events up to 24 months post-implant Summarize adverse events Implant to 24 months
Primary 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 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
Secondary 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
Secondary 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
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