Condition: Pulmonary Regurgitation · Sponsor: Venus MedTech (HangZhou) Inc.
A prospective, multi-center, non-randomized interventional study to evaluate the safety and effectiveness of the VenusP-ValveTM System in patients with native right ventricular outflow tract (RVOT) dysfunction. Post procedure, a clinical visit will be scheduled at pre-discharge, 30 days, 6 months, 12 months, and annually thereafter to 10 years. About 60 subjects will be enrolled in this study. Data analysis will be performed after all enrolled subjects complete 6-month follow-up and the primary endpoint analysis report will be submitted to FDA for PMA approval.
This description comes directly from the study's public registry record.
Cong Ma · +8618817939751 · macong@venusmedtech.com
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| Venusmedtech of America | Irvine, California, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06010563