Rivet PVS Therapy for Pulmonary Hypertension and Heart Failure

Recruiting at 1 trial location

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: 2

Duration: 1 day

What You Need to Know Before You Apply

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 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.

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

Rivet PVS Therapy may offer a unique approach by potentially targeting the pulmonary vasculature with minimal systemic effects, similar to the novel strategies seen in gene therapy for pulmonary circulation, which aim to address the limitations of current drug therapies. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

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

I have been diagnosed with a specific type of high blood pressure in the lungs due to heart failure.

I have chronic heart failure that affects my daily activities.

My heart failure treatment is stable and won't change for a month.

Exclusion Criteria

I need home oxygen, was hospitalized for lung issues recently, or have low lung function.

I have not had any heart-related treatments in the last 30 days.

Your mean RAP (right atrial pressure) is higher than 16 mmHg during a resting test.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo the Rivet Shunt Implantation Procedure

1 day

1 visit (in-person)

Initial Follow-up

Participants are monitored for major adverse events and technical success of the procedure

1 month

1 visit (in-person)

Extended Follow-up

Participants are monitored for adverse events, hemodynamic changes, and quality of life improvements

12 months

Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Rivet PVS Therapy

Trial Overview The Rivet PVS therapy is being tested for safety and effectiveness in treating patients with symptomatic pulmonary hypertension due to left heart disease (Group 2 PH-HFpEF). This early study involves multiple centers where participants will receive the new treatment without being compared to a control group.

How Is the Trial Designed?

Group I: Rivet Shunt Therapy Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

NXT Biomedical

Lead Sponsor

Trials

2

Citations

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

The evolving management of acute right-sided heart failure in cardiac transplant recipients. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Bosentan does not improve pulmonary hypertension and lung remodeling in heart failure. [2018]

3. Germany pubmed.ncbi.nlm.nih.gov

Does pretransplant left ventricular assist device therapy improve results after heart transplantation in patients with elevated pulmonary vascular resistance? [2022]

4. Australia pubmed.ncbi.nlm.nih.gov

Inhaled Iloprost and Oral Sildenafil Combination Therapy: Is it a Chance for Heart Transplant Candidacy? [2021]

5. Germany pubmed.ncbi.nlm.nih.gov

Use of centrifugal left ventricular assist device as a bridge to candidacy in severe heart failure with secondary pulmonary hypertension. [2022]

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

Transplantation in end-stage pulmonary hypertension (Third International Right Heart Failure Summit, part 3). [2020]

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

Inhaled Gene Transfer for Pulmonary Circulation. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Acute right heart failure: future perspective with the PERKAT RV pulsatile right ventricular support device. [2020]

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

Hemodynamic unloading leads to regression of pulmonary vascular disease in rats. [2022]

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

PDE5A inhibitor treatment of persistent pulmonary hypertension after mechanical circulatory support. [2021]