VenusP-Valve for Pulmonary Regurgitation

(PROTEUS Trial)

This trial tests a new heart valve treatment, the VenusP-Valve, for individuals with severe pulmonary regurgitation. Pulmonary regurgitation occurs when a leaky valve causes blood to flow backward into the heart, leading to symptoms like shortness of breath and fatigue. The trial aims to determine if transcatheter pulmonary valve implantation (TPVI) is safe and effective for those with a specific heart condition affecting blood flow. This treatment may suit individuals diagnosed with severe pulmonary valve leakage without serious valve narrowing. Participants will undergo regular follow-ups for up to 10 years to monitor outcomes. As an unphased trial, this study offers a unique chance to contribute to groundbreaking research and potentially benefit from an innovative treatment.

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Research shows that the VenusP-Valve, used in transcatheter pulmonary valve implantation (TPVI), is generally safe. In studies with patients suffering from severe pulmonary regurgitation, the VenusP-Valve was used without major complications. Specifically, one study found that 86% of patients did not experience serious problems over an average of 5.5 years, suggesting the procedure is usually well-tolerated. Other studies also support the VenusP-Valve's safety and effectiveness for midterm outcomes. Overall, the available evidence indicates that the VenusP-Valve is safe for treating issues in the right ventricular outflow tract.¹²³⁴⁵

The VenusP-ValveTM System is unique because it offers a minimally invasive solution for pulmonary regurgitation through transcatheter pulmonary valve implantation (TPVI). Unlike traditional surgical valve replacement, which requires open-heart surgery, TPVI can be performed via a catheter, reducing recovery time and potential complications. Researchers are excited about this treatment because it provides a less invasive alternative with the potential for quicker recovery and fewer risks, opening up options for patients who might not be candidates for surgery.

Research has shown that the VenusP-ValveTM System effectively treats problems in the heart's right ventricular outflow tract (RVOT). This trial will assess the VenusP-ValveTM System's effectiveness in reducing backward blood flow into the heart and improving heart function by placing a valve without surgery. One study found that all patients avoided needing another procedure within the first year, and the treatment remained successful over a longer period. The VenusP-Valve has also been used safely in patients, demonstrating good results even in the medium term. Overall, the VenusP-Valve is a safe and effective treatment option for people with RVOT issues.¹³⁵⁶⁷