Rivet Shunt for Pulmonary Hypertension with Heart Failure

Recruiting at 2 trial locations

Overseen By Krystal Santiago

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NXT Biomedical

Must be taking: Guideline directed medical therapy

Disqualifiers: Intracardiac intervention, PH Group 1, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 month

Trial Summary

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.

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 data supports the effectiveness of the Rivet PVS Therapy treatment for pulmonary hypertension with heart failure?

Research on the Potts shunt, a similar treatment, shows it can be effective for severe pulmonary hypertension, especially when medications don't work. It has been used to improve outcomes in children and delay the need for lung transplants. ^{1 2 3 4 5}

Is the Rivet Shunt generally safe for humans?

The reversed Potts shunt, similar to the Rivet Shunt, has been studied in children and adults with severe pulmonary hypertension, showing it can be a feasible and safe option, although it is a high-risk procedure. It has been used to improve heart function and delay the need for lung transplants in patients with severe conditions. ^{1 2 6 7 8}

How is Rivet PVS Therapy different from other treatments for pulmonary hypertension with heart failure?

Rivet PVS Therapy is unique because it likely involves a shunt similar to the Potts shunt, which creates a connection between the aorta and pulmonary artery to relieve pressure on the heart. This approach is different from standard drug treatments as it physically alters blood flow to improve heart function in severe cases of pulmonary hypertension. ^{2 4 5 6 9}

Eligibility Criteria

Inclusion Criteria

You can walk at least 150 meters in six minutes.

You have been diagnosed with certain types of heart problems and have specific test results to confirm it.

You have ongoing serious heart problems with specific symptoms, hospitalization for heart failure, or a certain blood test result.

Exclusion Criteria

Any therapeutic intracardiac intervention within the last 30 days

Your average RAP (right atrial pressure) is higher than 12 mmHg when measured at rest while breathing room air.

You have pulmonary hypertension due to certain causes.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Rivet PVS therapy and are monitored for safety and performance

1 month

In-person visits for implantation and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including changes in KCCQ score, RV chamber size, and hemodynamics

12 months

Regular follow-up visits, both in-person and virtual

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

Long-term

Treatment Details

Interventions

• Rivet PVS Therapy

Participant Groups

Group I: Rivet Shunt Therapy Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

NXT Biomedical

Lead Sponsor

Trials

2

References

1. England pubmed.ncbi.nlm.nih.gov

Management of systemic to pulmonary shunts and elevated pulmonary vascular resistance. [2023]

2. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Reversed Potts Shunt Outcome in Suprasystemic Pulmonary Arterial Hypertension: A Systematic Review and Meta-Analysis. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Midterm outcomes of the Potts shunt for pediatric pulmonary hypertension, with comparison to lung transplant. [2021]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Perventricular Implantation of Melody Valve in Child With Pulmonary Hypertension After a Potts Shunt. [2017]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Potts Shunt and Pediatric Pulmonary Hypertension: What We Have Learned. [2016]

6. England pubmed.ncbi.nlm.nih.gov

A case series of transcatheter Potts Shunt creation in a pediatric population affected with refractory pulmonary artery hypertension: focus on the role of ECMO. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Safety and Feasibility of the Transcatheter Approach to Create a Reverse Potts Shunt in Children With Idiopathic Pulmonary Arterial Hypertension. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

A novel unidirectional-valved shunt approach for end-stage pulmonary arterial hypertension: Early experience in adolescents and adults. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Closure of patent Potts shunt with aortic endoluminal stent graft. [2006]