Clinical Trials Logo

Clinical Trial 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).


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04543747
Study type Observational
Source Medtronic Cardiac Rhythm and Heart Failure
Contact
Status Completed
Phase
Start date June 11, 2015
Completion date December 5, 2020

See also
  Status Clinical Trial Phase
Not yet recruiting NCT06063811 - Ventricular Tachycardia Ablation in LVAD Patients
Withdrawn NCT04782245 - Acute Reno-Cardiac Action of Dapagliflozin In Advanced Heart Failure Patients on Heart Transplant Waiting List Phase 2
Active, not recruiting NCT04351945 - Endocrine Changes and Their Correction in Heart and Lung Transplant Recipients and Donors
Recruiting NCT03966313 - Perioperative Modification of Hemostasis During Ventricular Assist Device Implantation
Recruiting NCT02592499 - Swedish Evaluation of Left Ventricular Assist Device as Permanent Treatment in End-stage Heart Failure N/A
Active, not recruiting NCT00483197 - VentrAssistTM LVAD as a Bridge to Cardiac Transplantation - Pivotal Trial Phase 3
Active, not recruiting NCT00490321 - VentrAssistTM LVAD for the Treatment of Advanced Heart Failure - Destination Therapy Phase 3
Recruiting NCT04293575 - Transcatheter Mitral Valve Repair as Bridge Therapy to Heart Transplantation
Recruiting NCT04641416 - Noninvasive Cardiovascular Diagnosis of Patients With Fully Magnetically Levitated Blood Pumps
Completed NCT00490347 - VentrAssistTM LVAD as a Bridge to Cardiac Transplantation - Feasibility Trial Phase 2
Suspended NCT04117295 - Carmat TAH Early Feasibility Study N/A
Completed NCT05353816 - Corheart 6 Left Ventricular Assist System Prospective, Multicenter, Single-arm Clinical Evaluation Trial N/A
Completed NCT04480151 - ECLS Versus IMPELLA™ as Bridge to LVAD (ECI-BLAD)
Recruiting NCT04205760 - Preoperative Nutritional Optimization and Physical Exercise for Patients Scheduled for Elective Implantation for a Left-Ventricular Assist Device Phase 3
Recruiting NCT06345521 - Etablishment of Follow-up System and End-Stage Heart Registration Platform for Pediatric Heart Failure
Recruiting NCT04768322 - LVAD Versus GDMT in Ambulatory Advanced Heart Failure Patients N/A
Completed NCT02248974 - Development & Testing of a Decision Aid for LVAD Placement N/A
Completed NCT06152562 - Evaluation of Platelet Therapy Response in Left Ventricular Assist Device Patients
Completed NCT05928273 - Corheart 6 LVAS LTFU N/A
Recruiting NCT04951999 - AssocIation of PULSatility and Occurrence of Complications Related to Mechanically Assisted Circulatory Support N/A