VenusP-Valve Pivotal Study (PROTEUS STUDY)

Conditions

• Pulmonary Regurgitation

Eligibility Criteria

Sex

ALL

Age

12 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Transcatheter pulmonary valve implantation (TPVI) — DEVICE
  A valve is implanted through a catheter (a narrow tube) and inserted through the femoral vein into the right atrium, right ventricle and pulmonary artery. After careful positioning, the valve is implanted by inflating a set of a balloons on the delivery catheter or self-expanding. After the catheter has been removed, the incision is closed with stitches, which are removed after the area has healed.
• VenusP-ValveTM System — DEVICE
  VenusP-ValveTM System consists of two components: 1. Transcatheter Pulmonary Valve (TPV) 2. Delivery System (DS) including Delivery Catheter System (DCS) and Compression Loading System (CLS) The TPV consists of a self-expanding nitinol stent with a single layer tri-leaflet porcine pericardium tissue. For the Delivery Catheter System (DCS) , the distal (deployment) end of the system features an atraumatic, radiopaque tip. A protective sheath (capsule) covers and maintains the TPV in a crimped position. The handle at the proximal end of the catheter is used to load and deploy the TPV. The CLS compresses the TPV into the catheter, which including capture tube, valve protection tube, tip support tube, loading mandrels and crimper.

Study Details

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.

Key Dates

Start date

Jun 11, 2024

Status verified

Feb 2025

Primary completion

Jun 30, 2026

Completion

Aug 30, 2034

Study Design

Enrollment

60 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: TPVI

Primary Outcome Measure

The rate of procedure or device related mortality at the 30 days follow-up visit post procedure [ Time Frame: At 30 Days Post Procedure ]

Central Contacts

• Cong Ma
  +8618817939751
  [email protected]

Locations (1)

Find similar trials in Irvine, CA