Right Ventricular Outflow Tract DysfunctionRegistryNCT05835349
Observational Study of Venus P-Valve
An observational study of Right Ventricular Outflow Tract Dysfunction, run by Venus MedTech (HangZhou) Inc. at 10 sites in 4 countries.
Trial summary
Real-world evidence, retrospective and prospective, non-randomized, multicenter observational study of VenusP-ValveTM System in treating moderate or greater pulmonary regurgitation with/without pulmonary stenosis in patients with native right ventricular outflow tract (RVOT). Read more about this study
- Who is it for?
- Ages 12 to 70 years
- Conditions the study is for
- Right Ventricular Outflow Tract Dysfunction
- What is being tested?
- transcatheter pulmonary valve implantation (TPVI)
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 10 sitesin 4 countries
- Study dates
- 26 Aug 2024to Dec 2032
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 12 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Baseline enrolment criteria * 12 years old up to 70 years old * Weight ≥ 30kg * With evidence of moderate or severe (≥3+) pulmonary regurgitation by Transthoracic Echocardiography (TTE) * With >30% pulmonary regurgitation fraction as defined by cardiac Magnetic Resonance Imaging (MRI) * The subject is symptomatic from his/her pulmonary regurgitation or meets MRI criteria for intervention Right Ventricular Ejection Fraction (RVEF) < 45%, Pulmonary Regurgitant Fraction (PRRF) >30% and increased Right Ventricular End Diastolic Volume (RVEDV) Index (RVEDVI) >150mL/m²
Who may be able to join
- Patients with native RVOT (including transvalvular patch repair) are present with moderate or greater pulmonary regurgitation with/without stenosis and are clinically indicated for pulmonary valve intervention.
- The patient (or the patient's legally authorized representative) is willing to consent to participate in the study and will commit to completing all follow-up requirements.
Who cannot join
- 1. Patients with any condition contraindicated by the IFU or inability to comply with the Venus P-ValveTM System Instructions for Use or the study protocol.
Trial locations and contacts
10 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
10 sites in 4 countries
France4 sites, 4 recruiting
- Recruiting
Marie Lannelongue
Le Plessis-Robinson, Île-de-France Region, 92350
Sébastien HASCOËT, +33 6 72 64 10 18, hascoets@gmail.com
- Recruiting
Chu Nantes
Nantes, Pays de la Loire Region, 44093
Patrice GUERIN, +33 (0)2 40 16 55 89, patrice.guerin@chu-nantes.fr
- Recruiting
Hopital Necker-Enfants malades
Paris, Île-de-France Region, 75015
MILANI Guiti, 0033 1 4494344, guiti.milani@gmail.com
- Not yet recruiting
CHU Bordeaux
Pessac, New Aquitaine, 33600
Jean-Benoît THAMBO, (+33) 05 57 65 62 59, jean-benoit.thambo@chu-bordeaux.fr
Germany2 sites, 2 recruiting
- Not yet recruiting
Clinic of Congenital Heart Disease
Berlin, State of Berlin, 13353
Prof. Felix Berger, mailto:felix.berger@dhzc-charite.de
- Not yet recruiting
Heart CenterMunich
Munich, Bavaria, 81377
Dr. Stanimir Georgiev, georgiev@dhm.mhn.de
Italy2 sites, 2 recruiting
- Not yet recruiting
S. Donato Milan
Milan, Lombardy, 20097
Massimo Chessa, massimo.chessa@grupposandonato.it
- Not yet recruiting
OPBG Rome
Rome, Lazio, 165
BUTERA GIANFRANCO, gianfrancobutera@libero.it
United Kingdom2 sites, 2 recruiting
- Not yet recruiting
Leeds General Infirmary
Leeds, England, LS1 3EX
Dr. J. Bentham, Jamie.bentham@nhs.net
- Not yet recruiting
Evelina Children's Hospital
London, England, SE1 7EH
Prof. Sir S. Qureshi, mailto:Shakeel.Qureshi@gstt.nhs.uk
About this study
Official title: A Real-World Evidence Observational Study of VenusP-ValveTM System in the Treatment of Patients with Native RVOT Dysfunction
Real-world evidence, retrospective and prospective, non-randomized, multicenter observational study of VenusP-ValveTM System in treating moderate or greater pulmonary regurgitation with/without pulmonary stenosis in patients with native right ventricular outflow tract (RVOT).
Read the detailed description
All subjects will be followed up through five years for the observed outcome measures, which will be analyzed and reported to regulatory authorities as required.
Post-procedure, a clinical visit will be scheduled at discharge, thirty days, six months, one year, and annually thereafter to five years.
- Being tested
- transcatheter pulmonary valve implantation (TPVI)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcatheter pulmonary valve implantation (TPVI)Device
A stent-mounted valve is introduced over a guidewire and positioned in the RVOT, followed by balloon inflation to deploy the valve.
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-hierarchical composite endpoint
- Freedom from VenusP-ValveTM (catheter or surgical) reintervention
- Acceptable hemodynamic function, defined as:
- Mild or less regurgitation measured by echocardiography; AND
- Mean RVOT gradient as measured by echocardiography ≤35mmHg.
Measured: at six months
Secondary outcomes (4)
Procedural Success
Procedure success at 30 days, defined as:
- Freedom from procedure/device-related mortality
- Freedom from Venus P-ValveTM (catheter or surgical) reintervention concerning index procedure or device
- Acceptable hemodynamic function
- Original intended valve in situ
Measured: at 30 days
Occurrence of Events
Occurrence of the following events through 5 years of follow-up:
- All-cause mortality and procedure/device-related mortality
- Venus P-ValveTM (catheter or surgical) reintervention
- Venus P-ValveTM dysfunction
- Serious procedure/device-related adverse events
Measured: through five years
Functional status
New York Heart Association (NYHA) classification out to 5 years
Measured: through five years
Health-state utility score
Health-state utility score as measured by the EQ-5D at pre-implant, 30 days, 6 months, 1 year and annually thereafter through 5 years.
Measured: through five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2023
- Study start26 Aug 2024
- Primary completionAug 2026 (estimated)
- Study completionDec 2032 (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 DysfunctionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 200 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Venus MedTech (HangZhou) Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- IQVIA MedTech BV of Antwerp, Belgium, MDCECRO LLC
- Responsible party
- Sponsor
- Investigators
- Shakeel A. Qureshi, MD, Principal investigator, Evelina Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05835349
- Sponsor's protocol ID
- VTPR-22-08
- Acronym
- Registry
- Status last verified
- Jan 2025
- First submitted
- 18 Apr 2023
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Under attention to laws and regulations concerning personal data protection, empirical (non personally identifiable) data is anticipated to be shared within the clinical investigator team. Processed and analysed data would be shared within a wider community of medical professionals through professional conference presentations and peer-reviewed journal publications.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-World Evidence Observational Study of VenusP-ValveTM System in the Treatment of Patients with Native RVOT Dysfunction
- ClinicalTrials.gov ID
- NCT05835349
- Acronym / sponsor ID
- Registry / VTPR-22-08
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Venus MedTech (HangZhou) Inc.Industry (pharma, biotech, devices)
- Collaborators
- IQVIA MedTech BV of Antwerp, Belgium, MDCECRO LLC
- Study start
- 26 Aug 2024 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Dec 2032 (estimated)
- First posted
- 28 Apr 2023 (actual)
- 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.
Real-world evidence, retrospective and prospective, non-randomized, multicenter observational study of VenusP-ValveTM System in treating moderate or greater pulmonary regurgitation with/without pulmonary stenosis in patients with native right ventricular outflow tract (RVOT).
Detailed description
All subjects will be followed up through five years for the observed outcome measures, which will be analyzed and reported to regulatory authorities as required.
Post-procedure, a clinical visit will be scheduled at discharge, thirty days, six months, one year, and annually thereafter to five years.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 12 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Baseline enrolment criteria * 12 years old up to 70 years old * Weight ≥ 30kg * With evidence of moderate or severe (≥3+) pulmonary regurgitation by Transthoracic Echocardiography (TTE) * With >30% pulmonary regurgitation fraction as defined by cardiac Magnetic Resonance Imaging (MRI) * The subject is symptomatic from his/her pulmonary regurgitation or meets MRI criteria for intervention Right Ventricular Ejection Fraction (RVEF) < 45%, Pulmonary Regurgitant Fraction (PRRF) >30% and increased Right Ventricular End Diastolic Volume (RVEDV) Index (RVEDVI) >150mL/m²
Key inclusion criteria (2 listed)
- Patients with native RVOT (including transvalvular patch repair) are present with moderate or greater pulmonary regurgitation with/without stenosis and are clinically indicated for pulmonary valve intervention.
- The patient (or the patient's legally authorized representative) is willing to consent to participate in the study and will commit to completing all follow-up requirements.
Key exclusion criteria (1 listed)
- 1. Patients with any condition contraindicated by the IFU or inability to comply with the Venus P-ValveTM System Instructions for Use or the study protocol.
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 |
|---|---|---|
| transcatheter pulmonary valve implantation (TPVI)A stent-mounted valve is introduced over a guidewire and positioned in the RVOT, followed by balloon inflation to deploy the valve. | Device | – |
Primary outcome
Non-hierarchical composite endpoint
Time frame: at six months
* Freedom from VenusP-ValveTM (catheter or surgical) reintervention * Acceptable hemodynamic function, defined as: 1. Mild or less regurgitation measured by echocardiography; AND 2. Mean RVOT gradient as measured by echocardiography ≤35mmHg.
4 secondary outcomes
Procedural Success
Time frame: at 30 days
Occurrence of Events
Time frame: through five years
Functional status
Time frame: through five years
Health-state utility score
Time frame: through five years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
- Individual participant dataSharing planned: No. Under attention to laws and regulations concerning personal data protection, empirical (non personally identifiable) data is anticipated to be shared within the clinical investigator team. Processed and analysed data would be shared within a wider community of medical professionals through professional conference presentations and peer-reviewed journal publications.
Related trials for Right Ventricular Outflow Tract Dysfunction
Enrolling by invitation
Feasibility of Non-invasive Hemodynamic Assessment by 5D Flow in Congenital Heart Disease
Pulmonary Hypertension, Right Ventricular Outflow Tract Dysfunction
Not yet recruitingObservational study
VenusP-Valve™ System Long-term Follow-up 6-10 Years
Native Right Ventricle Outflow Tract(RVOT) Dysfunction
Active, not recruiting
Evaluation of the GORE PV1 Device in Patients With Pulmonary Valve Dysfunction
Heart Defects, Congenital, Tetralogy of Fallot
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.
Shakeel A. Qureshi, MD principal investigator
Evelina Children's Hospital
10 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Right Ventricular Outflow Tract Dysfunction, run by Venus MedTech (HangZhou) Inc. at 10 sites in 4 countries.
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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France, Germany, Italy, United Kingdom. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cong Ma (+86 18817939751, macong@venusmedtech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-hierarchical composite endpoint (time frame: at six months). 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 24 Jan 2025.