Rivet PVS Therapy for Pulmonary Hypertension and Heart Failure

No longer 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 tests a new treatment called Rivet PVS Therapy for individuals with pulmonary hypertension (high blood pressure in the lungs) and heart failure. The researchers aim to determine if this therapy is safe and effective in improving symptoms. It targets those with heart failure with preserved ejection fraction, where the heart pumps normally but remains stiff, and who experience symptoms like shortness of breath despite stable medication. Eligible participants should have had a heart failure-related hospital visit or increased medication use in the past year. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could lead to new treatment options.

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 prior data suggests that the Rivet PVS Therapy is safe for patients with pulmonary hypertension?

Research shows that Rivet PVS Therapy aims to help manage pulmonary hypertension, which is high blood pressure in the lungs, and heart failure. Without proper treatment, these conditions can lead to serious health issues. Early findings suggest that treatments like Rivet PVS Therapy, which ease the heart's ability to pump blood through the lungs, could be beneficial.

Although there is limited safety data for Rivet PVS Therapy, its testing in an early feasibility study indicates promise from earlier tests. These early studies are vital for understanding patient tolerance and identifying possible side effects. This step is crucial to ensure the treatment's safety before broader testing.

In similar treatments, such as the Potts shunt, research has shown potential benefits with manageable risks. However, each treatment differs, so participants should discuss any concerns with their healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Rivet PVS Therapy is unique because it offers a novel approach to treating pulmonary hypertension and heart failure by using a shunt to improve blood flow. Unlike traditional treatments like vasodilators or diuretics that focus on managing symptoms and reducing fluid buildup, Rivet PVS Therapy aims to directly alter the heart's structure to enhance its function. Researchers are excited about this therapy because it has the potential to provide more sustainable improvements in cardiac function and patient outcomes, potentially reducing the need for medications and hospital visits.

What evidence suggests that Rivet PVS Therapy might be an effective treatment for pulmonary hypertension?

Research suggests that Rivet PVS Therapy, the treatment under study in this trial, might help with pulmonary hypertension and heart failure by lowering resistance in the lung blood vessels. Reducing this resistance is crucial because it can improve blood flow and ease the heart's workload. Studies have shown that similar treatments, such as the Potts shunt, have been useful in managing symptoms of these conditions. Although the specific results of Rivet PVS Therapy are still under investigation, it operates on a similar principle to these existing methods. Early signs are promising, but more data is needed to fully understand its effectiveness. ^{2 3 4 5 6}

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.

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

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

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. clinicaltrials.gov clinicaltrials.gov/study/NCT05332873

Rivet PVS Therapy in Group 2 PH-HFpEF Canada Failure to submit primary and secondary outcomes. Correction: Shown ... Heart Failure. Hypertension, Pulmonary. Plan for Individual Participant Data (IPD).

2. withpower.com withpower.com/trial/phase-pulmonary-hypertension-ph-4-2022-6ecb5

Rivet PVS Therapy for Pulmonary Hypertension and Heart ... The research suggests that reducing pulmonary vascular resistance (PVR) is important in managing pulmonary hypertension and heart failure. Treatments like left ...

3. withpower.com withpower.com/trial/phase-heart-failure-3-2022-8bb93

Rivet Shunt for Pulmonary Hypertension with Heart Failure What data supports the effectiveness of the Rivet PVS Therapy treatment for pulmonary hypertension with heart failure? Research on the Potts shunt, a ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11981675/

Phase 2 Study to Evaluate the Efficacy and Safety ... Phase 2 Study to Evaluate the Efficacy and Safety of Inhaled Nitric Oxide Therapy in Patients With Severe Right Heart Failure Associated With Pulmonary ...

5. ahajournals.org ahajournals.org/doi/10.1161/JAHA.120.020633

Therapeutic Challenges and Emerging Treatment Targets ... Design of the beta3‐adrenergic agonist treatment in chronic pulmonary hypertension secondary to heart failure trial. JACC Basic Transl Sci ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7199161/

Pulmonary Hypertension in Heart Failure Patients - PMC The development of pulmonary hypertension (PH) in patients with heart failure is associated with increased morbidity and mortality.