Mechanical Circulatory Support Korea Post Market Surveillance Study (PMS)

Launched by MEDTRONIC CARDIAC RHYTHM AND HEART FAILURE · Sep 3, 2020

Keywords

ClinConnect Summary

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 patie...

Gender

ALL

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)