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Pulmonary RegurgitationPROTEUSNCT06010563

VenusP-Valve Pivotal Study (PROTEUS STUDY)

A study testing Transcatheter pulmonary valve implantation (TPVI) and VenusP-ValveTM System in people with Pulmonary Regurgitation, run by Venus MedTech (HangZhou) Inc. at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

A prospective, multi-center, non-randomized interventional study to evaluate the safety and effectiveness of the VenusP-ValveTM System in patients with native right ventricular outflow tract (RVOT) dysfunction. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Pulmonary Regurgitation
What is being tested?
Transcatheter pulmonary valve implantation (TPVI) and VenusP-ValveTM System
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
11 Jun 2024to 30 Aug 2034
Phase
Interventional
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 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Weight ≥25kg (55 lbs.)
  • Age ≥ 12 years olds
  • Patients have a dysfunctional native RVOT with severe pulmonary regurgitation (i.e., severe pulmonary regurgitation as determined by echocardiography or pulmonary regurgitant fraction ≥30% as determined by cardiac magnetic resonance imaging) and without significant pulmonary stenosis (significant pulmonary stenosis is defined as gradient more than 25mmHg) and are clinically indicated for intervention:
  • 1) For symptomatic patients, fitting the following criteria:
  • Severe pulmonary regurgitation measured by echocardiogram or pulmonary regurgitant fraction ≥30% measured by CMR 2) For asymptomatic patients, including any 2 of the following criteria:
  • Mild or moderate RV or LV systolic dysfunction.
  • Severe RV dilation (RVEDVI ≥145 mL/m2 or RVESVI ≥ 75 mL/m2or RVEDV >2 × LVEDV).
  • Progressive reduction in objective exercise tolerance. 4. Patient is willing to consent to participate in the study and will commit to completion of all follow-up requirements.

Who cannot join

  • Clinical or biological signs of infection including active endocarditis.
  • Echocardiographic evidence of intracardiac mass, thrombus, or vegetation.
  • Leukopenia, anemia, thrombocytopenia, or any known blood clotting disorder, deemed clinically significant after consultation with Haemato-oncology specialists.
  • Inappropriate anatomy for femoral or right internal jugular vein (RIJ) introduction and delivery of the VenusP-ValveTM System.
  • RVOT anatomy or morphology that is unfavorable for device anchoring.
  • Anatomy unable to accommodate VenusP-Valve delivery system.
Show all 17Show fewer
  • Angiographic evidence of coronary artery compression that would result from transcatheter pulmonary valve replacement (TPVR).
  • Emergency interventional/surgical procedures within 30 days prior to the index procedure.
  • Planned significant and relevant concomitant procedure at time of VenusP-Valve implant.
  • Any planned interventional/surgical procedures to be performed within the 30 days follow-up from VenusP-Valve implant.
  • Known history of intravenous drug abuse in the past 5 years, without certificate of completion of rehabilitation from a specialist.
  • Major or progressive non-cardiac disease resulting in a life expectancy of less than one year.
  • Known hypersensitivity or contraindication to antiplatelet, antithrombotic medications, or nitinol (titanium or nickel) leading to be unable to undergo index procedure per physicians' judgement
  • Positive pregnancy test at baseline (prior to CT angiography and again prior to implant procedure) in female patients of child-bearing potential.
  • Currently participating in an investigational drug or another device study.
  • Patient or guardian unwilling or unable to provide written informed consent or comply with follow-up requirements.
  • The investigators consider that the patients are not suitable to participate in this research.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Cong Ma contact

+8618817939751

macong@venusmedtech.com

United States1 site, 1 recruiting

  • Venusmedtech of America

    Irvine, California, 92618

    Frank Zeng

    Recruiting

Other trials in United States

About this study

Official title: Evaluation of the Performance of the VenusP-ValveTM System in Patients with Native RVOT Dysfunction

A prospective, multi-center, non-randomized interventional study to evaluate the safety and effectiveness of the VenusP-ValveTM System in patients with native right ventricular outflow tract (RVOT) dysfunction.

Post procedure, a clinical visit will be scheduled at pre-discharge, 30 days, 6 months, 12 months, and annually thereafter to 10 years.

About 60 subjects will be enrolled in this study. Data analysis will be performed after all enrolled subjects complete 6-month follow-up and the primary endpoint analysis report will be submitted to FDA for PMA approval.

Being tested
Transcatheter pulmonary valve implantation (TPVI), VenusP-ValveTM System
Medical subject headings
Pulmonary Valve Insufficiency

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 valve is implanted through a catheter (a narrow tube) and inserted through the femoral vein into the right atrium, right ventricle and pulmonary artery. After careful positioning, the valve is implanted by inflating a set of a balloons on the delivery catheter or self-expanding. After the catheter has been removed, the incision is closed with stitches, which are removed after the area has healed.

  • VenusP-ValveTM SystemDevice

    VenusP-ValveTM System consists of two components:

    1. Transcatheter Pulmonary Valve (TPV)
    2. Delivery System (DS) including Delivery Catheter System (DCS) and Compression Loading System (CLS) The TPV consists of a self-expanding nitinol stent with a single layer tri-leaflet porcine pericardium tissue.

    For the Delivery Catheter System (DCS) , the distal (deployment) end of the system features an atraumatic, radiopaque tip. A protective sheath (capsule) covers and maintains the TPV in a crimped position. The handle at the proximal end of the catheter is used to load and deploy the TPV.

    The CLS compresses the TPV into the catheter, which including capture tube, valve protection tube, tip support tube, loading mandrels and crimper.

Study groups in NCT06010563
Study groupRoleWhat they receive
TPVIExperimentalNot described
Receives: Device: Transcatheter pulmonary valve implantation (TPVI); Device: VenusP-ValveTM System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The rate of procedure or device related mortality at the 30 days follow-up visit post procedure

    Freedom from procedure or device related mortality at 30 days

    Measured: At 30 Days Post Procedure

  2. The rate of re-intervention and acceptable hemodynamic function at 6 Month follow-up visit post procedure

    Freedom from VenusP-Valve re-intervention and acceptable hemodynamic function at 6 months defined as:

    1. No more than mild regurgitation measured by CMR; AND
    2. Mean RVOT gradient as measured by echocardiography ≤35mmHg.

    Measured: At 6 Months Post Procedure

Secondary outcomes (7)

  1. The rate of all-cause mortality, procedure or device related mortality, and procedure or device related Major Adverse Cardiac and Cerebrovascular Events (MACCE) out to 10 years

    1. Freedom from all-cause mortality, procedure or device related mortality out to 10 years
    2. Freedom from procedure or device related Major Adverse Cardiac and Cerebrovascular Events (MACCE) out to 10 years
    3. MACCE is defined as a non-hierarchic composite including the following procedure or device related events:
    4. Stroke 2) RVOT reintervention 3) Arrhythmia 4) Coronary artery compression requiring intervention or causing myocardial infarction 5) Device-related endocarditis 6) Major stent fracture 7) Valve thrombosis 8) Valve embolization or significant malposition 9) Major vascular or access complications* 10) Pulmonary embolism

    Measured: Through Ten Years Post Procedure

  2. The rate of technical Success during the procedure

    Technical success at exit from catheterization lab or operating room

    Defined as a composite of:

    1. Freedom from procedure or device related mortality
    2. Successful access, delivery of the device, and retrieval of the delivery system
    3. Correct positioning of the valve(s) into the proper anatomical location
    4. Freedom from reintervention related to the device or to a major vascular or access-related, or cardiac structural complications

    Measured: During the Procedure

  3. The rate of acceptable hemodynamic performance at 30 days, 1-5 years, 7 years and 10 years.

    Acceptable hemodynamic performance at 30 days, 1-5 years, 7 years and 10 years.

    Defined as:

    1. Mean RVOT gradient ≤ 35mmHg AND,
    2. No more than mild regurgitation measured by echocardiography

    Measured: At 30 Days, 1-5 Years, 7 Years and 10 Years Post Procedure

  4. The rate of procedure success out to 30 days

    Procedure success out to 30 days, defined as follows:

    1. Device success at 30 days. Defined as a composite of:
    • Freedom from procedure or device related mortality
    • Original intended device in place
    • No additional surgical or interventional procedures related to the procedure or the device since completion of the index procedure
    • Hemodynamic performance: relief of insufficiency (mild or less pulmonary regurgitation) without producing the opposite (mean RVOT gradient > 35 mmHg) as measured by echocardiography
    • No new ventricular arrhythmia requiring ICD implantation
    1. None of the following procedure or device related serious adverse events:
    • Life-threatening major bleeding
    • Major vascular or cardiac structural complications requiring unplanned reintervention or surgery
    • Stage 2 or 3 acute kidney injury (AKI) includes new dialysis
    • Pulmonary embolism
    • Severe heart failure or hypotension requiring intravenous inotrope

    Measured: At 30 Days Post Procedure

  5. The rate of valve dysfunction out to 10 years

    Freedom from valve dysfunction out to 10 years

    Defined as a composite of:

    1. RVOT re-intervention for device-related reasons
    2. Hemodynamic dysfunction of the valve (moderate or greater pulmonary regurgitation, and/or a mean RVOT gradient > 35 mmHg)

    Measured: Through Ten Years Post Procedure

  6. New York Heart Association (NYHA) classification Through out to 10 years

    Functional status (New York Heart Association (NYHA) classification) out to 10 years

    Measured: Through Ten Years Post Procedure

  7. Characterization of quality-of-life scores out to 5 year, and at 10 years

    Characterization of quality-of-life scores out to 5 year, and at 10 years As assessed by the SF-36-QOL.

    Measured: Through Five Years Post Procedure, and at 10 Years Post Procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2023
  2. Study start11 Jun 2024
  3. Primary completion30 Jun 2026 (estimated)
  4. Study completion30 Aug 2034 (estimated)

Resources

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 N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06010563
Sponsor's protocol ID
VTPR-22-07
Acronym
PROTEUS
Status last verified
Feb 2025
First submitted
10 Aug 2023
Last updated
28 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Transcatheter pulmonary valve implantation (TPVI) and VenusP-ValveTM System in people with Pulmonary Regurgitation, run by Venus MedTech (HangZhou) Inc. at 1 site in United States.

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 17 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 28 Feb 2025. 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 United States. 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 (+8618817939751, macong@venusmedtech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The rate of procedure or device related mortality at the 30 days follow-up visit post procedure (time frame: At 30 Days Post Procedure). The study lists 2 primary outcomes in all. 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 NCT06010563.

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 28 Feb 2025.

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