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
This trial does not accept healthy volunteersQualifiers
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 population
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).
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Right ventricular reverse remodeling and improvement rate of right ventricular function were followed up at 6 months after operation
The right ventricular reverse remodeling and the improvement rate of right ventricular function at 6 months after operation were defined as the 6-month follow-up The right ventricular end-diastolic volume index measured by CMR was within the normal range, that is, RVEDVI≤108mL/m2.
Time frame
From enrollment to month-6 post procedure.Secondary outcomes
1
adverse events and moderate or greater pulmonary regurgitation at 6 years, 7 years, 8 years, 9 years and 10 years.
1. Occurrence of the following adverse events at 6 years, 7 years, 8 years, 9 years and 10 years: * Device migration/embolization * Valvar thrombosis * Thromboembolism * Bleeding * Paravalvular leak * Endocarditis * Nonstructural dysfunction * Explant * Hemolysis * Arrhythmias 2. Moderate or greater pulmonary regurgitation by echocardiography at 6 years, 7 years, 8 years, 9 years and 10 years.
Time frame
From enrollment to 10 years post procedure.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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