NCT04543747

Mechanical Circulatory Support Korea Post Market Surveillance Study (PMS)

Mechanical Circulatory Support Korea Post Market Surveillance Study (MCS Korea PMS)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 77 (actual)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

Conditions

• End-stage Heart Failure

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2015-06-11
• Primary completion: 2020-12-05
• Completion: 2020-12-05
• First posted: 2020-09-10
• Last updated: 2021-06-18

Locations

2 sites across 1 country: South Korea

Regulatory

• FDA-regulated device study