Right Ventricular Outflow Tract StenosisPhase 3NCT02071654
Efficacy and Safety of Venus P-valve to Treat RVOT Stenosis With Pulmonary Regurgitation
A Phase 3 study testing Venus P-valve transcatheter implantation in people with Right Ventricular Outflow Tract Stenosis, run by Venus MedTech (HangZhou) Inc. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Right Ventricular Outflow Tract Stenosis
- What is being tested?
- Venus P-valve transcatheter implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteChina
- Study dates
- Feb 2014to Feb 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, 200032
David Liu, MD, +86 10 6595 6828 ext. 806, davidliu@coremed.com.cn
Daxin Zhou, MD
About this study
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
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.
Read the 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.
- Conditions
- Right Ventricular Outflow Tract Stenosis
- Being tested
- Venus P-valve transcatheter implantation
- Keywords
- Venus P-valve
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venus P-valve transcatheter implantationDevice
Percutaneous implantation of Venus-P valve to treat RVOT stenosis patients
| Study group | Role | What they receive |
|---|---|---|
| Venus P-valve transcatheter implantation | Experimental | Single arm of percutaneous implantation of Venus-P valve for treating RVOT stenosis Receives: Device: Venus P-valve transcatheter implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement rate of RVEDV at 6 months post-procedure.
The improvement is defined as the RVEDVI≤108mL/m2 measured with CMR.
Measured: At 6 months post-implantation of Venus-P valve
Secondary outcomes (1)
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.
Measured: From the date of implantation until 12 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionFeb 2015 (estimated)
- Study completionFeb 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Right Ventricular Outflow Tract StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Venus MedTech (HangZhou) Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Core Medical (Beijing) Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Junbo Ge, Prof., MD., Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02071654
- Sponsor's protocol ID
- VEN2013-10/V2.0
- Status last verified
- Jan 2015
- First submitted
- 11 Jan 2014
- Last updated
- 6 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02071654
- Acronym / sponsor ID
- VEN2013-10/V2.0
- Conditions
- Right Ventricular Outflow Tract Stenosis
- Keywords
- Venus P-valve
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Venus MedTech (HangZhou) Inc.Industry (pharma, biotech, devices)
- Collaborators
- Core Medical (Beijing) Co., Ltd.
- Study start
- Feb 2014
- Primary completion
- Feb 2015 (estimated)
- Study completion
- Feb 2016 (estimated)
- First posted
- 26 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Venus P-valve transcatheter implantation | Experimental | Device: Venus P-valve transcatheter implantationSingle arm of percutaneous implantation of Venus-P valve for treating RVOT stenosis |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Venus P-valve transcatheter implantationPercutaneous implantation of Venus-P valve to treat RVOT stenosis patients | Device | Venus P-valve transcatheter implantation |
Primary outcome
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.
1 secondary outcome
Safety Endpoints
Time frame: From the date of implantation until 12 months post-procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2015.
Related trials for Right Ventricular Outflow Tract Stenosis
Active, not recruiting
Evaluation of the GORE PV1 Device in Patients With Pulmonary Valve Dysfunction
Heart Defects, Congenital, Tetralogy of Fallot
Recruiting
MASA Valve Early Feasibility Study
Tetrology of Fallot, Pulmonary Stenosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Junbo Ge, Prof., MD. principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Venus P-valve transcatheter implantation in people with Right Ventricular Outflow Tract Stenosis, run by Venus MedTech (HangZhou) Inc. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David Liu, MD (+86 10 6595 6828 ext. 806, davidliu@coremed.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement rate of RVEDV at 6 months post-procedure. (time frame: At 6 months post-implantation of Venus-P valve). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2015.