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Post Market Surveillance of the HeartMate 3 Left Ventricular Assist System in Hong Kong and Taiwan
Hong Kong and Taiwan HM3 PMS is a prospective, single arm, post market surveillance is designed to evaluate clinical and functional outcomes with the HM3 LVAS as a treatment for advanced heart failure. The PMS will enroll approximately 30 patients, that meet the HM3 commercially approved labelling indications, from approximately 4 sites in Hong Kong and Taiwan. PMS participants will be followed until the 24 months follow-up visit or until they experience an outcome, whichever comes first.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
University of Hong Kong
Hong Kong, Pokfulam, Hong Kong
National Taiwan University Hospital
Taipei, Taiwan
Tri-Service General Hospital
Taipei, Taiwan
Start Date
July 14, 2021
Primary Completion Date
March 31, 2022
Completion Date
June 30, 2022
Last Updated
July 1, 2024
3
ACTUAL participants
HeartMate 3™ left ventricular assist system (HM3 LVAS)
DEVICE
Lead Sponsor
Abbott Medical Devices
NCT06228209
NCT04475393
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07081035