Rivet PVS Therapy for Pulmonary Hypertension and Heart Failure
Trial Summary
Will I have to stop taking my current medications?
The trial requires that you stay on your current heart failure medications as long as they are stable and follow the guidelines set by your cardiologist. However, changes in diuretic doses for heart failure optimization are allowed within 30 days of the procedure.
What data supports the effectiveness of the treatment Rivet PVS Therapy for pulmonary hypertension and heart failure?
The research suggests that reducing pulmonary vascular resistance (PVR) is important in managing pulmonary hypertension and heart failure. Treatments like left ventricular assist devices (LVADs) and combination therapies such as inhaled iloprost and oral sildenafil have shown effectiveness in reducing PVR, which may indirectly support the potential effectiveness of Rivet PVS Therapy.12345
How is Rivet PVS Therapy different from other treatments for pulmonary hypertension and heart failure?
What is the purpose of this trial?
This trial is testing a new treatment called Rivet PVS therapy to see if it is safe and effective. It focuses on patients who have high blood pressure in their lungs that causes symptoms. The goal is to find out if this new therapy can help reduce their symptoms.
Eligibility Criteria
This trial is for adults with heart failure and pulmonary hypertension who've been hospitalized or have high NT-pro BNP levels. They must have a history of symptoms, be able to walk at least 100 meters, and be on stable heart medication. People with severe kidney issues, other types of pulmonary hypertension, significant right ventricular dysfunction, extreme blood pressure in the lungs, or severe heart failure are not eligible.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo the Rivet Shunt Implantation Procedure
Initial Follow-up
Participants are monitored for major adverse events and technical success of the procedure
Extended Follow-up
Participants are monitored for adverse events, hemodynamic changes, and quality of life improvements
Treatment Details
Interventions
- Rivet PVS Therapy
Find a Clinic Near You
Who Is Running the Clinical Trial?
NXT Biomedical
Lead Sponsor