Clinical trial NCT04543747: Mechanical Circulatory Support Korea Post Market Surveillance Study (PMS)
Official title: Mechanical Circulatory Support Korea Post Market Surveillance Study (MCS Korea PMS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: End-stage Heart Failure
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2020-09-10
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Survival rate up to 6 months and 24 months post-implant
timeFrame: Implant to 6 months, 24 months
Secondary outcomes:
measure: Quality of life, as measured by the Minnesota Living with Heart Failure Questionnaire (MLHFQ), up to 24 months post-implant
timeFrame: Implant up through 24 months
measure: Functional status, as measured by the New York Heart Association (NYHA) classification, up to 24 months post-implant
timeFrame: Implant up through 24 months
measure: Functional status, as measured by the 6-minute walk test, up to 24 months post-implant
timeFrame: Implant up through 24 months
Other outcomes:
measure: INTERMACS-defined Adverse Events up to 24 months post-implant
timeFrame: Implant to 24 months
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References: