Observational Study of Venus P-Valve
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12-70
SponsorVenus MedTech (HangZhou) Inc.
About this trial
Real-world evidence, retrospective and prospective, non-randomized, multicenter observational study of VenusP-ValveTM System in treating moderate or greater pulmonary regurgitation with/without pulmonary stenosis in patients with native right ventricular outflow tract (RVOT).
Eligibility criteria
Qualifiers
Patients with native RVOT (including transvalvular patch repair) are present with moderate or greater pulmonary regurgitation with/without stenosis and are clinically indicated for pulmonary valve intervention.
The patient (or the patient's legally authorized representative) is willing to consent to participate in the study and will commit to completing all follow-up requirements.
Disqualifiers
None
Trial design
Treatments tested in this trial
- transcatheter pulmonary valve implantation (TPVI)
Treatment groups
No treatment groups listed
Sponsors and collaborators
Venus MedTech (HangZhou) Inc.
Lead sponsor
IQVIA MedTech BV of Antwerp, Belgium
Collaborator
MDCECRO LLC
Collaborator
Source ClinicalTrials.gov