End-stage Heart Failure Clinical Trial
Official title:
Mechanical Circulatory Support Korea Post Market Surveillance Study (MCS Korea PMS)
Verified date | June 2021 |
Source | Medtronic Cardiac Rhythm and Heart Failure |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
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) |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Asan Medical Center | Seoul | |
Korea, Republic of | Samsung Medical Center | Seoul |
Lead Sponsor | Collaborator |
---|---|
Medtronic Cardiac Rhythm and Heart Failure |
Korea, Republic of,
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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