Efficacy and Safety of Venus P-valve to Treat RVOT Stenosis With Pulmonary Regurgitation (NCT02071654) | Clinical Trial Compass
UnknownPhase 3
Efficacy and Safety of Venus P-valve to Treat RVOT Stenosis With Pulmonary Regurgitation
China44 participantsStarted 2014-02
Plain-language 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.
Who can participate
Age range18 Years – 60 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* Ileofem…
What they're measuring
1
Improvement rate of RVEDV at 6 months post-procedure.
Timeframe: At 6 months post-implantation of Venus-P valve