VenusP-Valve™ System Long-term Follow-up 6-10 Years
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorVenus MedTech (HangZhou) Inc.
About this trial
The goal of this study is to assess the long-term safety, efficacy and performance of VenusP-Valve™ implantation. in all subjects who provided informed consent and received VenusP-Valve™ implantation in the VenusP-Valve™ system CE registration study (Protocol ID Number: VMT-001CE; NCT02846753).
Annual clinic visits will be conducted from year 6 through year 10 post-implantation, including transthoracic echocardiography, New York Heart Association (NYHA) functional classification assessment, adverse event evaluation, and review of cardiovascular medication use at each visit..
Eligibility criteria
Qualifiers
The subject or the subject's legal representative has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent as approved by the ethics committee and regulatory authority if applicable of the respective clinical site
Disqualifiers
The investigators consider that the patients are not suitable to participate in this study.
Trial design
Treatments tested in this trial
- Not listed
Trial groups
No trial groups listed
Locations
Sponsors and collaborators
Source ClinicalTrials.gov