What side effects are associated with this type of intervention?

Common treatments for heart failure, particularly those addressing pulmonary hypertension, include adaptive servo-ventilation (ASV) therapy, pacemakers, and systemic therapies. ASV therapy can improve left ventricular contractility and remodeling but may have side effects such as discomfort from the device and potential respiratory issues. Pacemakers, especially those involving right ventricular pacing, can increase the risk of heart failure hospitalizations, atrial fibrillation, and mortality. Systemic therapies, like epoprostenol for pulmonary arterial hypertension, can cause side effects including catheter-related infections, jaw pain, diarrhea, and flushing. It is essential to discuss these potential side effects with a healthcare provider to tailor the treatment plan to the patient's specific needs.

What prior FDA approvals exist?

FDA-approved treatments for heart failure that target the pulmonary vascular system include medications such as endothelin receptor antagonists (e.g., bosentan), phosphodiesterase-5 inhibitors (e.g., sildenafil), and soluble guanylate cyclase stimulators (e.g., riociguat). These drugs work by dilating the pulmonary arteries and reducing pulmonary vascular resistance, which can help alleviate symptoms and improve outcomes in patients with heart failure and associated pulmonary hypertension. While the Rivet PVS therapy is a novel approach, these existing treatments share a common goal of improving pulmonary hemodynamics.

What other types of research exist?

Promising novel alternatives to Rivet PVS for heart failure patients include the Parachute device for percutaneous ventricular restoration, which is designed to treat patients with ischemic heart failure and dilated left ventricles. Additionally, the totally implantable Novacor left ventricular assist system (LVAS) has shown efficacy in chronic in vivo evaluations, demonstrating normal hemodynamics and minimal hemolysis. These alternatives offer innovative approaches to managing heart failure and improving patient outcomes.

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Pulmonary Artery Shunt

Rivet PVS Therapy for Pulmonary Hypertension and Heart Failure

Q: What is the mechanism of action of this treatment?

Common treatments for heart failure (HF) include medications such as ACE inhibitors, beta-blockers, diuretics, and aldosterone antagonists, which work by reducing the workload on the heart, controlling blood pressure, and preventing fluid buildup. Device-based therapies like cardiac resynchronization therapy (CRT) and implantable cardioverter-defibrillators (ICDs) help improve heart rhythm and prevent sudden cardiac death. The Rivet PVS therapy, which targets the pulmonary vascular system, aims to reduce pulmonary hypertension, thereby decreasing the strain on the right ventricle and improving overall heart function. These treatments are crucial for HF patients as they help manage symptoms, improve quality of life, and reduce mortality.

N/A

Waitlist Available

Research Sponsored by NXT Biomedical

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Prior diagnosis of Group 2 PH due to HFpEF, with confirmed resting hemodynamic criteria by right heart catheterization

Chronic symptomatic heart failure documented by NYHA HF Class II with history > II, or Class III, or ambulatory Class IV

Must not have

Chronic pulmonary disease defined as requires continuous home oxygen therapy, recent hospitalization for exacerbation within 12 months prior to screening, or FEV1 < 50% predicted

Severe heart failure, defined as ACC/AHA/ESC Stage D heart failure, non-ambulatory NYHA Class IV HF, Cardiac Index < 2.0 L/min/m2, continuous intravenous inotropic infusion, mechanical circulatory support, on the cardiac transplant waiting list

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed here, interventions like the Rivet Shunt may cause complications such as irregular heartbeat, bleeding, infection risk from the procedure itself or device-related problems that could affect lung or heart function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I have chronic heart failure that affects my daily activities.

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I have been hospitalized for heart failure or needed strong diuretics recently.

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I am 18 years old or older.

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I can walk 100 meters or more without stopping.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have severe heart failure and may need a heart transplant.

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My heart's right ventricle is not functioning properly.

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My kidney function is low, with an eGFR under 35.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Rate of Major Adverse Events

Rate of Technical Success of the Rivet Shunt Implantation Procedure

Secondary study objectives

Adverse Events through 12 months

Change in Hemodynamics at 12 months - PCWP

Change in Kansas City Cardiomyopathy Questionnaire

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Rivet Shunt TherapyExperimental Treatment1 Intervention

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for heart failure (HF) include medications such as ACE inhibitors, beta-blockers, diuretics, and aldosterone antagonists, which work by reducing the workload on the heart, controlling blood pressure, and preventing fluid buildup. Device-based therapies like cardiac resynchronization therapy (CRT) and implantable cardioverter-defibrillators (ICDs) help improve heart rhythm and prevent sudden cardiac death. The Rivet PVS therapy, which targets the pulmonary vascular system, aims to reduce pulmonary hypertension, thereby decreasing the strain on the right ventricle and improving overall heart function. These treatments are crucial for HF patients as they help manage symptoms, improve quality of life, and reduce mortality.

Right ventricular failure in congenital heart disease.