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Rivet PVS Therapy for Pulmonary Hypertension and Heart Failure

Recruiting at 1 trial location
KS
Overseen ByKrystal Santiago
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: NXT Biomedical
Must be taking: Guideline directed medical therapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

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.678910

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

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.
See 2 more

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.
See 4 more

Timeline

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)

Treatment Details

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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Rivet Shunt TherapyExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

NXT Biomedical

Lead Sponsor

Trials
2

References

The evolving management of acute right-sided heart failure in cardiac transplant recipients. [2019]
Bosentan does not improve pulmonary hypertension and lung remodeling in heart failure. [2018]
Does pretransplant left ventricular assist device therapy improve results after heart transplantation in patients with elevated pulmonary vascular resistance? [2022]
Inhaled Iloprost and Oral Sildenafil Combination Therapy: Is it a Chance for Heart Transplant Candidacy? [2021]
Use of centrifugal left ventricular assist device as a bridge to candidacy in severe heart failure with secondary pulmonary hypertension. [2022]
Transplantation in end-stage pulmonary hypertension (Third International Right Heart Failure Summit, part 3). [2020]
Inhaled Gene Transfer for Pulmonary Circulation. [2018]
Acute right heart failure: future perspective with the PERKAT RV pulsatile right ventricular support device. [2020]
Hemodynamic unloading leads to regression of pulmonary vascular disease in rats. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
PDE5A inhibitor treatment of persistent pulmonary hypertension after mechanical circulatory support. [2021]
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