RECRUITING

VenusP-Valve Pivotal Study (PROTEUS STUDY)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Evaluation of the Performance Of The VenusP-ValveTM System in Patients With Native RVOT Dysfunction

Quick Facts

Study Start:2024-06-11

Study Completion:2034-08-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06010563

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Weight ≥25kg (55 lbs.) 2. Age ≥ 12 years olds 3. 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: * 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.	1. Clinical or biological signs of infection including active endocarditis. 2. Echocardiographic evidence of intracardiac mass, thrombus, or vegetation. 3. Leukopenia, anemia, thrombocytopenia, or any known blood clotting disorder, deemed clinically significant after consultation with Haemato-oncology specialists. 4. Inappropriate anatomy for femoral or right internal jugular vein (RIJ) introduction and delivery of the VenusP-ValveTM System. 5. RVOT anatomy or morphology that is unfavorable for device anchoring. 6. Anatomy unable to accommodate VenusP-Valve delivery system. 7. Angiographic evidence of coronary artery compression that would result from transcatheter pulmonary valve replacement (TPVR). 8. Emergency interventional/surgical procedures within 30 days prior to the index procedure. 9. Planned significant and relevant concomitant procedure at time of VenusP-Valve implant. 10. Any planned interventional/surgical procedures to be performed within the 30 days follow-up from VenusP-Valve implant. 11. Known history of intravenous drug abuse in the past 5 years, without certificate of completion of rehabilitation from a specialist. 12. Major or progressive non-cardiac disease resulting in a life expectancy of less than one year. 13. Known hypersensitivity or contraindication to antiplatelet, antithrombotic medications, or nitinol (titanium or nickel) leading to be unable to undergo index procedure per physicians' judgement 14. Positive pregnancy test at baseline (prior to CT angiography and again prior to implant procedure) in female patients of child-bearing potential. 15. Currently participating in an investigational drug or another device study. 16. Patient or guardian unwilling or unable to provide written informed consent or comply with follow-up requirements. 17. The investigators consider that the patients are not suitable to participate in this research.

Inclusion Criteria

Exclusion Criteria

1. Weight ≥25kg (55 lbs.)
2. Age ≥ 12 years olds
3. 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:
* 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.

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

Contacts and Locations

Study Contact

Cong Ma

CONTACT

+8618817939751

macong@venusmedtech.com

Study Locations (Sites)

Venusmedtech of America

Irvine, California, 92618

United States

Collaborators and Investigators

Sponsor: Venus MedTech (HangZhou) Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-11

Study Completion Date2034-08-30

Study Record Updates

Study Start Date2024-06-11

Study Completion Date2034-08-30

Terms related to this study

Additional Relevant MeSH Terms

Pulmonary Regurgitation