Mechanical Circulatory Support Korea Post Market Surveillance Study (PMS)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

77 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-06-11

Study Completion Date

2020-12-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Post Market Surveillance of the HeartMate 3 Left Ventricular Assist System in Korea

NCT04915924

Advanced Heart Failure

COMPLETED NA

Evaluation of the HeartWare Left Ventricular Assist Device for the Treatment of Advanced Heart Failure

NCT00751972

Chronic Heart Failure

COMPLETED NA

Interventional Left Ventricular Assist System for PCI in CHIP Patients

NCT07053618

High-Risk Percutaneous Coronary Intervention (High-risk PCI) Left Ventricular Assist Devices

RECRUITING NA

Mitral Regurgitation Treatment in Advanced Heart Failure

NCT05292716

Heart Failure Mitral Regurgitation

RECRUITING NA

EFS of the CardioMech MVRS

NCT04820764

Mitral Regurgitation

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

End-stage Heart Failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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).

HeartWare Ventricular Assist Device

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

HVAD

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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 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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No