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

NCT02071654 | Unknown Phase 3 DMC

• 1 other identifier: VEN2013-10/V2.0
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Right Ventricular Outflow Tract Stenosis

Keywords

Venus P-valve

Outcome Measures

Primary Outcomes (1)

• Improvement rate of RVEDV at 6 months post-procedure.

  The improvement is defined as the RVEDVI≤108mL/m2 measured with CMR.

  At 6 months post-implantation of Venus-P valve

Secondary Outcomes (1)

• Safety Endpoints

  From the date of implantation until 12 months post-procedure

Other Outcomes (2)

• Feasibility and Performance Endpoints

  Day 7 post-implantation

• Secondary Endpoints

  From the date of valve implantation till 12 months post-procedure

Study Arms (1)

Venus P-valve transcatheter implantation

EXPERIMENTAL

Single arm of percutaneous implantation of Venus-P valve for treating RVOT stenosis

Device: Venus P-valve transcatheter implantation

Interventions

Venus P-valve transcatheter implantation DEVICE

Percutaneous implantation of Venus-P valve to treat RVOT stenosis patients

Venus P-valve transcatheter implantation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• RVOT stenosis who have undergone transannular patch repair with moderate to severe pulmonary regurgitation
• Isotopic or CMR criteria of RVEDVI≥130mL/m2 and ≤160mL/m2
• Age≥18 years and ≤60 years (Zhongshan Hospital age≥18 years and ≤60 years
• Body weight≥18 kg
• Pulmonary annular diameter between 14mm to 31mm
• RVOT length≥20mm
• The subject or his/her legal representative has provided written informed consent
• Subject will comply with protocol required follow-ups
• Add any of the following conditions:
• Subject is symptomatic
• Subject presents with \>30% pulmonary regurgitation fraction as defined by cardiac MRI
• ≥3+ pulmonary regurgitation by echocardiograms
• Deteriorating RVEF%
• Progressive tricuspid valve regurgitation (at least moderate degree)
• Complicated with RVOT obstruction (RV systolic pressure\>80mmHg)

You may not qualify if:

• Candidates will be excluded from the study if any of the following conditions are present:
• Existing pulmonary artery branch stenosis or artificial pulmonary valve
• Severe chest wall deformity
• ADHF
• Active infection or endocarditis requiring antibiotic therapy
• Leukopenia (WBC\<3000mm3)
• Acute or chronic anemia (Hb\<9g/L)
• Platelet account \<100,000 cells/mm3
• In the judgment of the investigator, percutaneous introduction and delivery of the valve is not feasible
• A known hypersensitivity to aspirin or heparin
• Positive urine or serum pregnancy test in female subjects
• Ileofemoral vessel characteristics that would preclude safe placement of introducer sheath

Sponsors & Collaborators

• Venus MedTech (HangZhou) Inc.: lead
• Core Medical (Beijing) Co., Ltd.: collaborator

Study Sites (1)

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Study Officials

• Junbo Ge, Prof., MD.

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Liu, MD

CONTACT

+86 10 6595 6828; davidliu@coremed.com.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2014
• First Posted: February 26, 2014
• Study Start: February 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2016
• Last Updated: January 6, 2015

Record last verified: 2015-01

Locations

CN (1)