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New treatment option for Pulmonary Regurgitation
Official title VenusP-Valve Pivotal Study (PROTEUS STUDY)
ClinicalTrials.gov ID: NCT06010563
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 and older
You may be able to join if
- 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...
- Severe pulmonary regurgitation measured by echocardiogram or pulmonary regurgitant fraction ≥30% measured by CMR 2) For asymptomatic patients...
- Mild or moderate RV or LV systolic dysfunction.
You likely can't join if
- 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...
- 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.
See the full eligibility criteria
- 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...
- 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.
- 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.
- Angiographic evidence of coronary artery compression that would result from transcatheter pulmonary valve replacement (TPVR).
- Emergency treatment/surgical procedures within 30 days prior to the index procedure.
- Planned significant and relevant concomitant procedure at time of VenusP-Valve implant.
- Any planned treatment/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.
The study team makes the final eligibility decision.
Where it's taking place
- Irvine, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Irvine, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.