Pulmonary RegurgitationPhase 2/3Venus-PNCT02590679
Multi-center Trial of Percutaneous Pulmonary Valve Implantation With Venus-p
A Phase 2/3 study testing Venues-P Valve in people with Pulmonary Regurgitation and Tetralogy of Fallot, run by Shanghai Zhongshan Hospital at 3 sites in China.
Trial summary
Venus-P Valve (Venus Medtech, Shanghai, China) is the first self-expandable interventional Pulmonary Valve, which is composed of a Nitinol multilevel support frame with a tri-leaflet porcine pericardial tissue valve, and a 14-22 Fr delivery catheter. Read more about this study
- Who is it for?
- Ages 10 to 60 years
- Conditions the study is for
- Pulmonary Regurgitation, Tetralogy of Fallot
- What is being tested?
- Venues-P Valve
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 3 sitesChina
- Study dates
- May 2013to Feb 2017
- Phase
- Phase 2/3
- 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 10 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Moderate to severe pulmonary regurgitation after surgical repair of congenital right ventricular outflow tract obstruction with trans-annulus or RVOT patch;
- right ventricular diastolic volume index: 130-160 mL/m2 measured by isotopic examination or cardiac MRI measurements;
- Age: ≥10 years and ≤60 years;
- Weight ≥18 Kg;
- Pulmonary annulus : 14- 31 mm;
- RVOT length ≥20mm ;
- Signing the informed consent;
- Any of the following conditions: ① symptomatic, ②progressive RV systolic dysfunction, ③ progressive tricuspid regurgitation (at least moderate), ④ RVOT obstruction with RV systolic pressure ≥80 mmHg, ⑤ Sustained atrial/ventricular arrhythmias.
Who cannot join
- Pre-existing pulmonary artery stenosis or artificial pulmonary valve at any position;
- Severe chest wall deformity (funnel chest, etc.);
- Acute uncompensated heart failure;
- Active infection or endocarditis requiring antibiotic therapy;
- Leukopenia (white blood cell <3000 mm3);
- Acute or chronic anemia (hemoglobin <9 g/L);
Show all 10Show fewer
- Platelet counts <10000 /mm3;
- Impossibly of delivering Venus-P to RVOT as judged by researcher s before procedure;
- Known allergy to aspirin or heparin;
- Positive urine or serum pregnancy test in female subjects.
Trial locations and contacts
3 sites in 1 country.
Wenzhi Pan, M.D. contact
China3 sites, 3 recruiting
- Recruiting
Beijing Fuwai Hospital
Beijing
Gejun Zhang, M.D.
- Recruiting
Zhongshan Hopital of Fudan University
Shanghai, Shanghai Municipality, 200032
Wenzhi Pan, M.D., peden@sina.com
- Recruiting
Shanghai Chest Hospital
Shanghai
Xin Pan, M.D.
About this study
Official title: Multi-center Trial of Percutaneous Pulmonary Valve Implantation Using Venus-P Valve for Patients With Severe Pulmonary Regurgitation and Native Right Ventricular Outflow Tract After Previous Surgical Repair
Venus-P Valve (Venus Medtech, Shanghai, China) is the first self-expandable interventional Pulmonary Valve, which is composed of a Nitinol multilevel support frame with a tri-leaflet porcine pericardial tissue valve, and a 14-22 Fr delivery catheter. The purpose of the multi-center trial is to evaluate the safety and efficacy of the Venus-P Valve for percutaneous pulmonary valve implantation (PPVI) in patients pulmonary regurgitation and native right ventricular outflow tract (RVOT) after surgical repair of RVOT.
Read the detailed description
Clinical experience to date with transcatheter pulmonary valve replacement has been limited to two balloon expandable systems, namely the Melody Valve (Medtronic Inc, Minneapolis, MN) and the Sapien valve (Edwards Lifesciences, Irvine, CA). Both valves have undergone clinical trials with good medium-term valve durability. Although both the Melody and the Sapien valves have been used in native outflow tracts with good success , limitations to the extended application of these valves have generally centered on the maximum diameter of the RVOT. Indeed in the majority of patients requiring pulmonary valve replacement (PVR), these balloon expandable systems are not large enough to maintain stable valve position within the dilated native RVOT.Therefore more recent efforts have concentrated on a self-expanding system to provide valve competence despite significant dilation of the native RVOT.
Venus-P Valve (Venus Medtech, Shanghai, China) is the first self-expandable interventional Pulmonary Valve, which is composed of a Nitinol multilevel support frame with a tri-leaflet porcine pericardial tissue valve, and a 14-22 Fr delivery catheter. The purpose of the trial is to evaluate the safety and efficacy of the Venus-P Valve for PPVI in patients pulmonary regurgitation and native RVOT after surgical repair of RVOT.
- Conditions
- Pulmonary Regurgitation, Tetralogy of Fallot
- Being tested
- Venues-P Valve
- Medical subject headings
- Pulmonary Valve Insufficiency, Tetralogy of Fallot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venues-P ValveDevice
a Novel Self-Expanding Percutaneous Stent-Valve in the Native Right Ventricular Outflow Tract
| Study group | Role | What they receive |
|---|---|---|
| PRAS | Experimental | pulmonary regurgitation after surgical repair of congenital right ventricular outflow tract Receives: Device: Venues-P Valve |
What is being measured
The primary outcome is the main question the study is designed to answer.
right ventricular end diastolic volume index
Measured: 6 months
Secondary outcomes (6)
Incidence of adverse cardiovascular events
death, severe arrhythmia, pericardial tamponade, emergency surgery, RVOT rupture, pulmonary artery perforation, cardiac shock, endocarditis, bleeding , and other complications caused by procedure
Measured: 48 hours
Incidence of deaths or strokes
All cause deaths (cardiac death, and non cardiac death) or strokes
Measured: 12 months
pulmonary pressure gradient
Max pressure gradient (PG)
Measured: 1,3,6,12 months
grade of pulmonary regurgitation
Measured: 1,3,6,12 months
New York Heart Association (NYHA) class
Measured: 1,3,6,12 months
6 minutes walk distance
Measured: 1,3,6,12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2015 (estimated)
- Study startMay 2013
- Primary completionJul 2016 (estimated)
- Study completionFeb 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary RegurgitationStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fu Wai Hospital, Beijing, China, Huaxi Hospital, Shanghai Chest Hospital, Shanghai Children's Medical Center
- Responsible party
- Sponsor
- Investigators
- Junbo Ge, M.D., Study chair, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02590679
- Sponsor's protocol ID
- PPVI-2013
- Acronym
- Venus-P
- Status last verified
- Oct 2015
- First submitted
- 15 Oct 2015
- Last updated
- 29 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cao QL, Kenny D, Zhou D, Pan W, Guan L, Ge J, Hijazi ZM. Early clinical experience with a novel self-expanding percutaneous stent-valve in the native right ventricular outflow tract. Catheter Cardiovasc Interv. 2014 Dec 1;84(7):1131-7. doi: 10.1002/ccd.25544. Epub 2014 May 28.
PubMed 24824357
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center Trial of Percutaneous Pulmonary Valve Implantation Using Venus-P Valve for Patients With Severe Pulmonary Regurgitation and Native Right Ventricular Outflow Tract After Previous Surgical Repair
- ClinicalTrials.gov ID
- NCT02590679
- Acronym / sponsor ID
- Venus-P / PPVI-2013
- Conditions
- Pulmonary Regurgitation, Tetralogy of Fallot
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Collaborators
- Fu Wai Hospital, Beijing, China, Huaxi Hospital, Shanghai Chest Hospital, Shanghai Children's Medical Center
- Study start
- May 2013
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Feb 2017 (estimated)
- First posted
- 29 Oct 2015 (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.
Venus-P Valve (Venus Medtech, Shanghai, China) is the first self-expandable interventional Pulmonary Valve, which is composed of a Nitinol multilevel support frame with a tri-leaflet porcine pericardial tissue valve, and a 14-22 Fr delivery catheter. The purpose of the multi-center trial is to evaluate the safety and efficacy of the Venus-P Valve for percutaneous pulmonary valve implantation (PPVI) in patients pulmonary regurgitation and native right ventricular outflow tract (RVOT) after surgical repair of RVOT.
Detailed description
Clinical experience to date with transcatheter pulmonary valve replacement has been limited to two balloon expandable systems, namely the Melody Valve (Medtronic Inc, Minneapolis, MN) and the Sapien valve (Edwards Lifesciences, Irvine, CA). Both valves have undergone clinical trials with good medium-term valve durability. Although both the Melody and the Sapien valves have been used in native outflow tracts with good success , limitations to the extended application of these valves have generally centered on the maximum diameter of the RVOT. Indeed in the majority of patients requiring pulmonary valve replacement (PVR), these balloon expandable systems are not large enough to maintain stable valve position within the dilated native RVOT.Therefore more recent efforts have concentrated on a self-expanding system to provide valve competence despite significant dilation of the native RVOT.
Venus-P Valve (Venus Medtech, Shanghai, China) is the first self-expandable interventional Pulmonary Valve, which is composed of a Nitinol multilevel support frame with a tri-leaflet porcine pericardial tissue valve, and a 14-22 Fr delivery catheter. The purpose of the trial is to evaluate the safety and efficacy of the Venus-P Valve for PPVI in patients pulmonary regurgitation and native RVOT after surgical repair of RVOT.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PRAS | Experimental | Device: Venues-P Valvepulmonary regurgitation after surgical repair of congenital right ventricular outflow tract |
Who may qualify
- Ages
- 10 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Moderate to severe pulmonary regurgitation after surgical repair of congenital right ventricular outflow tract obstruction with trans-annulus or RVOT patch;
- right ventricular diastolic volume index: 130-160 mL/m2 measured by isotopic examination or cardiac MRI measurements;
- Age: ≥10 years and ≤60 years;
- Weight ≥18 Kg;
- Pulmonary annulus : 14- 31 mm;
Key exclusion criteria (10 listed)
- Pre-existing pulmonary artery stenosis or artificial pulmonary valve at any position;
- Severe chest wall deformity (funnel chest, etc.);
- Acute uncompensated heart failure;
- Active infection or endocarditis requiring antibiotic therapy;
- Leukopenia (white blood cell <3000 mm3);
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 |
|---|---|---|
| Venues-P Valvea Novel Self-Expanding Percutaneous Stent-Valve in the Native Right Ventricular Outflow Tract | Device | PRAS |
Primary outcome
right ventricular end diastolic volume index
Time frame: 6 months
6 secondary outcomes
Incidence of adverse cardiovascular events
Time frame: 48 hours
Incidence of deaths or strokes
Time frame: 12 months
pulmonary pressure gradient
Time frame: 1,3,6,12 months
grade of pulmonary regurgitation
Time frame: 1,3,6,12 months
New York Heart Association (NYHA) class
Time frame: 1,3,6,12 months
6 minutes walk distance
Time frame: 1,3,6,12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2015.
- Results publication: PubMed 24824357Cao QL, Kenny D, Zhou D, Pan W, Guan L, Ge J, Hijazi ZM. Early clinical experience with a novel self-expanding percutaneous stent-valve in the native right ventricular outflow tract. Catheter Cardiovasc Interv. 2014 Dec 1;84(7):1131-7. doi: 10.1002/ccd.25544. Epub 2014 May 28.
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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.
Wenzhi Pan, M.D. contact
Junbo Ge, M.D. study chair
Fudan University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Venues-P Valve in people with Pulmonary Regurgitation and Tetralogy of Fallot, run by Shanghai Zhongshan Hospital at 3 sites 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 8 inclusion and 10 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 29 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Wenzhi Pan, M.D. (peden@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
right ventricular end diastolic volume index (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02590679, which also lists 1 linked publication.
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 29 Oct 2015.