Mechanical Circulatory Support Korea Post Market Surveillance Study (PMS)

NCT04543747 | Completed FDA Device

• 1 other identifier: MCS Korea PMS
• Study Type: observational
• Target: 77
• Locations: 1 country
• Sites: 2

Brief 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).

Conditions

End-stage Heart Failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Quality of life, as measured by the Minnesota Living with Heart Failure Questionnaire (MLHFQ), up to 24 months post-implant

  Implant up through 24 months

• Functional status, as measured by the New York Heart Association (NYHA) classification, up to 24 months post-implant

  Implant up through 24 months

• Functional status, as measured by the 6-minute walk test, up to 24 months post-implant

  Implant up through 24 months

Other Outcomes (1)

• INTERMACS-defined Adverse Events up to 24 months post-implant

  Implant to 24 months

Study Arms (1)

Patients implanted with HVAD System

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

Interventions

HeartWare Ventricular Assist Device 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.

Also known as: HVAD

Patients implanted with HVAD System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who require treatment with a HVAD for use as a bridge to cardiac transplantation (BTT) or a destination therapy (DT) within the re-examination period are eligible for enrollment into the MCS Korea PMS.

You may qualify if:

• 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

You may not qualify if:

• Patient who is, or is expected to be inaccessible for follow-up
• 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)

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (2)

Asan Medical Center

Seoul, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2020
• First Posted: September 10, 2020
• Study Start: June 11, 2015
• Primary Completion: December 5, 2020
• Study Completion: December 5, 2020
• Last Updated: June 18, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2)