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NCT06010563 · ClinicalTrials.gov registry record · NA
VenusP-Valve Pivotal Study (PROTEUS STUDY)
A NA study of Pulmonary Regurgitation, sponsored by Venus MedTech (HangZhou).
- Recruiting
- Registry status
- NA
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT06010563 is a NA study of Pulmonary Regurgitation that is actively recruiting participants, run by Venus MedTech (HangZhou). The registered enrollment target is 60 participants, below the 118-participant average among 4 other Pulmonary Regurgitation trials with a reported enrollment target (49% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06010563, a NA study of Pulmonary Regurgitation, is actively recruiting participants, sponsored by Venus MedTech (HangZhou).
- RECRUITING
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Conditions Studied
Interventions
- DEVICE Transcatheter pulmonary valve implantation (TPVI)
- DEVICE VenusP-ValveTM System
Study Locations (1)
California
- Venusmedtech of America - Irvine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2024-06-11 |
| Est. Completion | 2034-08-30 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06010563
The ClinicalTrials.gov registry entry for NCT06010563 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 118-participant average among 4 other Pulmonary Regurgitation trials with a reported enrollment target (49% lower). The listed sponsor is Venus MedTech (HangZhou), which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Pulmonary Regurgitation appearing as the primary indexed condition, and to 2 interventions - of which Transcatheter pulmonary valve implantation (TPVI) is the first listed.
NCT06010563 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT06010563 about?
NCT06010563 is a clinical study titled "VenusP-Valve Pivotal Study (PROTEUS STUDY)". 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, ...
What is the current status of trial NCT06010563?
This trial is currently recruiting. It is a NA study. The enrollment target is 60 participants. The study started on 2024-06-11. Estimated completion is 2034-08-30.
What conditions does trial NCT06010563 study?
This clinical trial studies the following conditions: Pulmonary Regurgitation.
What interventions are being tested in trial NCT06010563?
The interventions under investigation include: Transcatheter pulmonary valve implantation (TPVI) (DEVICE), VenusP-ValveTM System (DEVICE).
Who is sponsoring clinical trial NCT06010563?
This trial is sponsored by Venus MedTech (HangZhou), which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06010563 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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