NCT02071654

Efficacy and Safety of Venus P-valve to Treat RVOT Stenosis With Pulmonary Regurgitation

Efficacy and Safety Evaluation of Transcatheter Pulmonary Valve Implantation for Right Ventricular Outflow Tract (RVOT) Stenosis After Congenital Heart Defect Surgical Correction Complicated With Severe Pulmonary Regurgitation

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: Venus MedTech (HangZhou) Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

A prospective, non-randomized, multi-center clinical study of the Venus P-valve for the treatment of RVOT stenosis with pulmonary regurgitation after surgery of congenital heart defect.

Detailed description

The aim of this protocol is to assess the efficacy, safety and performance of Venus P-valve. Patients between 18-60 years with RVOT stenosis and moderate to severe pulmonary regurgitation (≥3+) who have undergone trans-annular patch repair of their RVOT, cardiac magnetic resonance (CMR) screening right ventricular end-diastolic volume index (RVEDVI) between 130-160mL/m2. Post-procedure follow-ups will be scheduled at 24 hours, 30 days, 6 months and 12 months.

Conditions

• Right Ventricular Outflow Tract Stenosis

Interventions

Type	Name	Description
DEVICE	Venus P-valve transcatheter implantation	Percutaneous implantation of Venus-P valve to treat RVOT stenosis patients

Timeline

• Start date: 2014-02-01
• Primary completion: 2015-02-01
• Completion: 2016-02-01
• First posted: 2014-02-26
• Last updated: 2015-01-06

Locations

1 site across 1 country: China