Rivet Shunt for Pulmonary Hypertension with Heart Failure
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called Rivet PVS Therapy, a type of shunt procedure, to determine its effectiveness for people with pulmonary hypertension and heart failure. Researchers aim to assess the safety and efficacy of this therapy. Suitable candidates include those with heart failure experiencing symptoms like difficulty breathing or fatigue, recent heart-related hospital visits, and current management of their condition with medication. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research and potentially benefit from an innovative treatment.
Will I have to stop taking my current medications?
The trial requires that participants continue their current stable heart failure medications as directed by their doctor, without changes for 6 months, except for adjustments in diuretic doses.
What prior data suggests that the Rivet PVS Therapy is safe for patients with pulmonary hypertension?
Research shows that Rivet PVS Therapy may help manage high blood pressure in the lungs and heart failure by lowering resistance in the lung's blood vessels. This is important for patients with these conditions. Earlier studies have not found major safety issues, suggesting the treatment might be safe for most people. However, since this is an early study, researchers continue to monitor its safety closely. Participants should discuss any concerns with their doctors to understand the possible risks and benefits.12345
Why are researchers excited about this trial?
Unlike the standard treatments for pulmonary hypertension with heart failure, like vasodilators or endothelin receptor antagonists, Rivet PVS Therapy introduces a novel approach by using a shunt mechanism. This therapy is unique because it creates a physical passageway in the pulmonary vasculature, potentially reducing the pressure in the pulmonary arteries directly. Researchers are excited about this treatment because it targets the underlying mechanical issues contributing to the disease, offering a potentially more direct and immediate effect on reducing symptoms and improving heart function. It represents a shift from chemical-based treatments to a structural intervention, which could be particularly beneficial for patients who have not responded well to conventional therapies.
What evidence suggests that the Rivet PVS Therapy is effective for pulmonary hypertension?
Research shows that Rivet PVS Therapy, which participants in this trial will receive, aims to manage pulmonary hypertension by lowering resistance in the lung blood vessels. Reducing this resistance can lessen heart strain and improve symptoms for patients with pulmonary hypertension and heart failure. Studies of similar treatments, such as the Potts shunt, have shown positive results, suggesting that Rivet PVS Therapy could be effective. While researchers are still gathering specific data on Rivet PVS Therapy, the concept is based on a solid understanding of managing these conditions.13456
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the Rivet PVS therapy and are monitored for safety and performance
Follow-up
Participants are monitored for safety and effectiveness after treatment, including changes in KCCQ score, RV chamber size, and hemodynamics
Open-label extension (optional)
Participants may opt into continuation of treatment long-term
What Are the Treatments Tested in This Trial?
Interventions
- Rivet PVS Therapy
Find a Clinic Near You
Who Is Running the Clinical Trial?
NXT Biomedical
Lead Sponsor