PROTEUS
VenusP-Valve Pivotal Study (PROTEUS STUDY)
AI Description
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.
- Who can join
- child, adult, older adult
- Participants
- 60
- Expected completion
- 2034-08-30
- Funded by
- industry
Conditions studied
Pulmonary Regurgitation
What is being tested
- DEVICE: Transcatheter pulmonary valve implantation (TPVI)
- DEVICE: VenusP-ValveTM System
What it measures
- The rate of procedure or device related mortality at the 30 days follow-up visit post procedure, Freedom from procedure or device related mortality at 30 days, At 30 Days Post Procedure
- The rate of re-intervention and acceptable hemodynamic function at 6 Month follow-up visit post procedure, Freedom from VenusP-Valve re-intervention and acceptable hemodynamic function at 6 months defined as: 1. No more than mild regurgitation measured by CMR; AND 2. Mean RVOT gradient as measured by echocardiography ≤35mmHg., At 6 Months Post Procedure
Centers Participating
We do not have location details for this study yet. The registry listing above names its sites.
Registry entry updated 2025-02-28
Deciding whether to join a study is your choice, and you can ask a study team questions before you decide anything.
If you would rather we did it with you, call us on (656) 206-4686.