Efficacy and Safety of Venus P-valve to Treat RVOT Stenosis With Pulmonary Regurgitation
NCT ID: NCT02071654
Last Updated: 2015-01-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
44 participants
INTERVENTIONAL
2014-02-28
2016-02-29
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Venus P-valve transcatheter implantation
Single arm of percutaneous implantation of Venus-P valve for treating RVOT stenosis
Venus P-valve transcatheter implantation
Percutaneous implantation of Venus-P valve to treat RVOT stenosis patients
Interventions
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Venus P-valve transcatheter implantation
Percutaneous implantation of Venus-P valve to treat RVOT stenosis patients
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
60 Years
ALL
No
Sponsors
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Core Medical (Beijing) Co., Ltd.
OTHER
Venus MedTech (HangZhou) Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Junbo Ge, Prof., MD.
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Locations
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Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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VEN2013-10/V2.0
Identifier Type: -
Identifier Source: org_study_id
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