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

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ClinicalTrials.gov Identifier: NCT02071654
Recruitment Status : Unknown
Verified January 2015 by Venus MedTech (HangZhou) Inc..
Recruitment status was:  Recruiting
First Posted : February 26, 2014
Last Update Posted : January 6, 2015
Sponsor:
Collaborator:
Core Medical (Beijing) Co., Ltd.
Information provided by (Responsible Party):
Venus MedTech (HangZhou) Inc.

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.

Condition or disease Intervention/treatment Phase
Right Ventricular Outflow Tract Stenosis Device: Venus P-valve transcatheter implantation Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : February 2014
Estimated Primary Completion Date : February 2015
Estimated Study Completion Date : February 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Venus P-valve transcatheter implantation
Single arm of percutaneous implantation of Venus-P valve for treating RVOT stenosis
Device: Venus P-valve transcatheter implantation
Percutaneous implantation of Venus-P valve to treat RVOT stenosis patients




Primary Outcome Measures :
  1. Improvement rate of RVEDV at 6 months post-procedure. [ Time Frame: At 6 months post-implantation of Venus-P valve ]
    The improvement is defined as the RVEDVI≤108mL/m2 measured with CMR.


Secondary Outcome Measures :
  1. Safety Endpoints [ Time Frame: From the date of implantation until 12 months post-procedure ]

    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.



Other Outcome Measures:
  1. Feasibility and Performance Endpoints [ Time Frame: Day 7 post-implantation ]

    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. )


  2. Secondary Endpoints [ Time Frame: From the date of valve implantation till 12 months post-procedure ]

    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02071654


Contacts
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Contact: David Liu, MD +86 10 6595 6828 ext 806 davidliu@coremed.com.cn

Locations
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China, Shanghai
Zhongshan Hospital Fudan University Recruiting
Shanghai, Shanghai, China, 200032
Contact: David Liu, MD    +86 10 6595 6828 ext 806    davidliu@coremed.com.cn   
Principal Investigator: Daxin Zhou, MD         
Sponsors and Collaborators
Venus MedTech (HangZhou) Inc.
Core Medical (Beijing) Co., Ltd.
Investigators
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Principal Investigator: Junbo Ge, Prof., MD. Fudan University

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Responsible Party: Venus MedTech (HangZhou) Inc.
ClinicalTrials.gov Identifier: NCT02071654     History of Changes
Other Study ID Numbers: VEN2013-10/V2.0
First Posted: February 26, 2014    Key Record Dates
Last Update Posted: January 6, 2015
Last Verified: January 2015
Keywords provided by Venus MedTech (HangZhou) Inc.:
Venus P-valve
Additional relevant MeSH terms:
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Respiratory Insufficiency
Pulmonary Valve Insufficiency
Constriction, Pathologic
Pathological Conditions, Anatomical
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases