Mechanical Circulatory Support Korea Post Market Surveillance Study (PMS)

End-stage Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04543747
• Other study ID #: MCS Korea PMS
• Status: Completed
• 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
• 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
• 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)

Related Conditions & MeSH terms

• End-stage Heart Failure
• Heart Failure

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