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
|Condition or disease||Intervention/treatment||Phase|
|Right Ventricular Outflow Tract Stenosis||Device: Venus P-valve transcatheter implantation||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||44 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
- 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.
- 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. )
- 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
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
|Contact: David Liu, MD||+86 10 6595 6828 ext firstname.lastname@example.org|
|Zhongshan Hospital Fudan University||Recruiting|
|Shanghai, Shanghai, China, 200032|
|Contact: David Liu, MD +86 10 6595 6828 ext 806 email@example.com|
|Principal Investigator: Daxin Zhou, MD|
|Principal Investigator:||Junbo Ge, Prof., MD.||Fudan University|