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

Primary Purpose

Right Ventricular Outflow Tract Stenosis

Status

Unknown status

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Venus P-valve transcatheter implantation

About this trial

This is an interventional treatment trial for Right Ventricular Outflow Tract Stenosis focused on measuring Venus P-valve

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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)
Persistent arrhythmias

Exclusion Criteria:

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

Sites / Locations

Zhongshan Hospital Fudan UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Venus P-valve transcatheter implantation

Arm Description

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

Outcomes

Primary Outcome Measures

Improvement rate of RVEDV at 6 months post-procedure.

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

Secondary Outcome Measures

Safety Endpoints

Accumulated occurrences (rate of patients/year) of procedure-related clinical events (death, severe arrhythmias, cardiac tamponade, RVOT or pulmonary artery perforation or rupture, cardiac shock, endocarditis from the date of valve implantation up to 12 months post-procedure or bleeding due to use of heparin/aspirin at 48 hours post-procedure assessed per protocol. Occurrence of all deaths (cardiac death, non-cardiac deaths and other deaths) and stroke one year post-procedure.

Full Information

NCT ID

NCT02071654

First Posted

January 11, 2014

Last Updated

January 3, 2015

Sponsor

Venus MedTech (HangZhou) Inc.

Collaborators

Core Medical (Beijing) Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT02071654

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2015

Overall Recruitment Status

Unknown status

Study Start Date

February 2014 (undefined)

Primary Completion Date

February 2015 (Anticipated)

Study Completion Date

February 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Venus MedTech (HangZhou) Inc.

Collaborators

Core Medical (Beijing) Co., Ltd.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Right Ventricular Outflow Tract Stenosis

Keywords

Venus P-valve

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Venus P-valve transcatheter implantation

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Venus P-valve transcatheter implantation

Intervention Description

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

Primary Outcome Measure Information:

Title

Improvement rate of RVEDV at 6 months post-procedure.

Description

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

Time Frame

At 6 months post-implantation of Venus-P valve

Secondary Outcome Measure Information:

Title

Safety Endpoints

Description

Time Frame

From the date of implantation until 12 months post-procedure

Other Pre-specified Outcome Measures:

Title

Feasibility and Performance Endpoints

Description

Immediate success of implantation of the device measured in percentage (placement of the device and functional stability measured with angiography and hemodynamic performance). Function normal of the P valve measured in percentage without major adverse events at day 7. (Function normal defined as the P valve's position and function are normal through exams of electrocardiography (EKG), transthoracic echocardiogram (TTE), chest X-ray. )

Time Frame

Day 7 post-implantation

Title

Secondary Endpoints

Description

Changes of images and clinical parameters pre- and post-procedure at 12 months. CMR: right ventricular volume (expressed as ml/m2), RV ejection fraction (expressed as percentage), pulmonary regurgitation (functional classification as grade I, IIa, IIb and III). Echo: device position(expressed as percentage), hemodynamic performance of velocity of RVOT and pulmonary valve (expressed as m/s), transvalvular pressure gradient, peak pulmonary valve gradient, mean gradient (expressed as the difference of pressure in mmHg.) NYHA class

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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) Persistent arrhythmias Exclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

David Liu, MD

Phone

+86 10 6595 6828

Ext

806

davidliu@coremed.com.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Junbo Ge, Prof., MD.

Organizational Affiliation

Fudan University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Zhongshan Hospital Fudan University

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

David Liu, MD

Phone

+86 10 6595 6828

Ext

806

davidliu@coremed.com.cn

First Name & Middle Initial & Last Name & Degree

Daxin Zhou, MD

12. IPD Sharing Statement

Learn more about this trial

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

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