Mechanical Circulatory Support Korea Post Market Surveillance Study (PMS)
- Conditions
- End-stage Heart Failure
- Interventions
- Device: HeartWare Ventricular Assist Device
- Registration Number
- NCT04543747
- Lead Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- 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).
- Detailed 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 & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 77
- 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
- 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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients implanted with HVAD System HeartWare Ventricular Assist Device 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).
- Primary Outcome Measures
Name Time Method Survival rate up to 6 months and 24 months post-implant Implant to 6 months, 24 months 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.
- Secondary Outcome Measures
Name Time Method 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 Characterize changes in quality of life over time
Functional status, as measured by the New York Heart Association (NYHA) classification, up to 24 months post-implant Implant up through 24 months Characterize changes in NYHA class over time
Functional status, as measured by the 6-minute walk test, up to 24 months post-implant Implant up through 24 months Characterize changes in 6-min walk test results (walked distance in meters) over time
Trial Locations
- Locations (2)
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of