V-Wave Interatrial Shunt for Pulmonary Hypertension

(RELIEVE-PAH Trial)

Recruiting at 2 trial locations

Overseen By William T. Abraham, M.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: V-Wave Ltd

Must be taking: PAH therapy

Disqualifiers: Severe lung disease, Organ dysfunction, others

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

Compensation: Varies

Number of Visits: 2

Duration: 3 months

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called the V-Wave Interatrial Shunt for individuals with severe pulmonary arterial hypertension, a type of high blood pressure affecting the lungs. The goal is to determine if the device is safe, effective, and capable of improving symptoms. The trial seeks participants who have experienced severe symptoms despite stable medication for at least three months. It may suit those with pulmonary hypertension due to specific causes such as idiopathic origins, connective tissue disease, or corrected congenital heart disease, and who face serious daily life limitations. As an unphased trial, this study offers 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 does not specify if you need to stop taking your current medications. However, it requires that you have been on stable doses of your current pulmonary arterial hypertension (PAH) medications for at least one month before joining.

What prior data suggests that the V-Wave Interatrial Shunt is safe for patients with pulmonary hypertension?

Research has shown that the V-Wave Interatrial Shunt has been safely used in studies with heart failure patients. In these studies, the shunt was successfully placed without causing immediate problems during the procedure. Most patients (90%) had the device implanted without any issues.

The shunt is designed to help manage pressure in the heart and is made to be safe for patients. Trials have demonstrated that it can reduce health problems related to heart failure. This is promising because it suggests the shunt may also be safe for people with high blood pressure in the lungs (pulmonary hypertension).

Overall, data from heart failure studies suggest that the V-Wave Interatrial Shunt is well-tolerated and does not cause major side effects immediately after implantation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The V-Wave Interatrial Shunt is unique because it offers a mechanical solution to managing pulmonary hypertension by redirecting blood flow between the atria of the heart. Unlike standard treatments that typically rely on medications to relax blood vessels or reduce fluid buildup, the V-Wave Shunt physically alters the heart's structure to alleviate pressure, potentially offering a more direct and sustained relief. Researchers are excited about this approach because it could provide a new option for patients who don't respond well to current drug therapies, and it may improve quality of life by directly targeting the heart's function.

What evidence suggests that the V-Wave Interatrial Shunt is effective for pulmonary hypertension?

Research has shown that the V-Wave Interatrial Shunt has been studied for treating heart failure, yielding mixed results. This device can lower pressure in the heart's left atrium, potentially improving heart failure symptoms. Some studies found that patients with specific heart conditions experienced a reduction in heart chamber size, typically a positive sign. However, other research did not identify clear benefits or harms directly linked to the shunt. In this trial, the V-Wave Interatrial Shunt is being tested for pulmonary hypertension, with hopes of managing heart pressures similarly. ^{1 2 3 4 6}

Who Is on the Research Team?

Victor Tapson, M.D.

Principal Investigator

Cedars-Sinai Medical Center

Are You a Good Fit for This Trial?

This trial is for adults with severe pulmonary arterial hypertension, specifically those classified as WHO Functional Class III or IV. Participants must have been on stable PAH medication for at least 3 months and meet certain risk criteria. Exclusions include individuals with significant heart rhythm issues, low left ventricular ejection fraction, severe lung disease, specific anatomical anomalies, very low oxygen levels without support, or other organ dysfunction.

Inclusion Criteria

My heart condition severely limits my activity or I'm unable to do any activity without discomfort.

I have been on the strongest PAH medication I can tolerate for over 3 months.

My PAH is related to a specific cause like idiopathic, HIV, or heart disease.

Exclusion Criteria

My veins are not suitable for a specific heart procedure.

Your oxygen level is less than 90% when measured at rest without extra oxygen, adjusted for the altitude you are at.

Your right atrial pressure is consistently higher than 20 mmHg.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants undergo diagnostic right heart catheterization and V-Wave Shunt implantation

3 months

Regular visits for monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Regular visits at 1 and 12 months

Long-term Follow-up

Participants are followed annually for a total of 5 years post-implant

5 years

What Are the Treatments Tested in This Trial?

Interventions

• V-Wave Interatrial Shunt

Trial Overview The RELIEVE-PAH study is testing the V-Wave Interatrial Shunt device in patients with severe pulmonary arterial hypertension to assess its safety and performance. The goal is to see if this new treatment can help reduce symptoms of right ventricular failure by improving blood flow.

How Is the Trial Designed?

Group I: Therapy: V-Wave Shunt Experimental Treatment 1 Intervention

Treatment arm patients will undergo a diagnostic right heart catheterization and invasive echocardiography to determine study eligibility followed by transseptal catheterization and V-Wave Shunt implantation.

Who Is Running the Clinical Trial?

V-Wave Ltd

Lead Sponsor

Trials

5

Recruited

650+

Published Research Related to This Trial

In a study of 86 adult patients with ventriculoatrial (VA) shunts, 8% were found to have pulmonary hypertension, highlighting a significant risk associated with this treatment for hydrocephalus.

The study suggests that regular echocardiography and pulmonary function tests, including DLCO measurements, should be conducted in VA shunt patients to monitor for pulmonary hypertension and prevent serious cardiopulmonary complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulmonary hypertension after ventriculoatrial shunt implantation. Kluge, S., Baumann, HJ., Regelsberger, J., et al.[2016]

In a study of 575 patients with pulmonary hypertension, 6 adults (average age 42.5 years) were found to have received ventriculoatrial (VA) shunts, indicating a potential link between VA shunt placement and the development of pulmonary hypertension over a median period of 16.5 years.

Despite the serious nature of pulmonary hypertension, the outcomes for these patients were generally positive, with a 100% survival rate in the first 8 years after diagnosis, suggesting that early recognition and management may lead to favorable results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of pulmonary hypertension in adults after ventriculoatrial shunt implantation. Kluge, S., Baumann, HJ., Regelsberger, J., et al.[2009]

Creating a restrictive left-to-right interatrial shunt can help reduce elevated left atrial filling pressures in heart failure patients, potentially preventing pulmonary congestion and acute decompensation.

Clinical studies have shown that this new therapeutic strategy, using devices like V-Wave and IASD, is safe and can improve hemodynamic parameters, functional status, and quality of life for patients with heart failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Creation of a restrictive atrial left-to-right shunt: a novel treatment for heart failure. De Rosa, R., Schranz, D.[2019]

The V-Wave device, designed to reduce left atrial pressure by creating a shunt to the right atrium, was successfully implanted in a 70-year-old man with chronic heart failure, demonstrating its feasibility and safety with no complications during the procedure.

At three months post-implantation, the patient showed significant improvements in heart function and quality of life, including a reduction in NT-proBNP levels and a decrease in pulmonary wedge pressure, indicating effective left atrial decompression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Left atrial decompression through unidirectional left-to-right interatrial shunt for the treatment of left heart failure: first-in-man experience with the V-Wave device. Amat-Santos, IJ., Bergeron, S., Bernier, M., et al.[2021]

The InterAtrial Shunt Device (IASD®) has been shown to effectively reduce left atrial pressure in patients with diastolic heart failure and pulmonary venous hypertension, leading to sustained hemodynamic improvements and enhanced quality of life.

Despite concerns about paradoxical embolisms, the IASD® has demonstrated a low risk of complications, making it a promising treatment option for selected patients with severe symptoms of diastolic heart failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[InterAtrial Shunt Device in diastolic heart failure]. Hasenfuß, G., Jacobshagen, C.[2019]

In a study involving 30 male pigs, the pulmonary artery-left atrium (PA-LA) shunt demonstrated superior hemodynamic performance compared to the right atrial-left atrium (RA-LA) shunt, effectively reducing right ventricular afterload and improving blood flow.

The PA-LA shunt showed a fourfold higher mean pressure and better flow in the left anterior descending artery, suggesting it may be a more effective intervention for relieving symptoms of right ventricular failure caused by severe pulmonary hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute pressure overload of the right ventricle. Comparison of two models of right-left shunt. Pulmonary artery to left atrium and right atrium to left atrium: experimental study. Argiriou, M., Mikroulis, D., Sakellaridis, T., et al.[2021]

Citations

1. vwavemedical.com vwavemedical.com/vwave/clinical_research/

Clinical Research This study is assessing the safety and effectiveness of the V-Wave® Ventura® Interatrial Shunt for the treatment of heart failure (HF).

2. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.124.070870

Interatrial Shunt Treatment for Heart Failure An interatrial shunt may provide an autoregulatory mechanism to decrease left atrial pressure and improve heart failure (HF) symptoms and prognosis.

3. vwavemedical.com vwavemedical.com/v-wave-announces-late-breaking-primary-results-from-pivotal-double-blind-randomized-controlled-relieve-hf-trial-of-the-ventura-interatrial-shunt-showing-reduced-clinical-events-in-advanced-he/

V-Wave Announces Late-Breaking Primary Results from ... Overall, the primary effectiveness endpoint was neutral, neither showing shunt-related benefit or harm. Analysis of the LVEF subgroups showed ...

4. jacc.org jacc.org/doi/10.1016/j.jcmg.2025.08.005

Mechanistic Basis for Differential Effects of Interatrial Shunt ... In shunt-treated vs control patients with HFrEF, there were reductions in median LV end-diastolic volumes (−11.9 mL/m2 [Q1-Q3: −21.3 to −2.5 mL/ ...

5. eurointervention.pcronline.com eurointervention.pcronline.com/article/initial-experience-with-the-second-generation-v-wave-shunt-for-treating-patients-with-chronic-heart-failure

Interatrial shunt with the second-generation V-Wave ... The present study reports the first-in-human experience with the second generation of the V-Wave shunt in patients with advanced chronic HF.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03499236

Study Details | NCT03499236 | Reducing Lung CongestIon ... The objective of the RELIEVE-HF study is to provide reasonable assurance of safety and effectiveness of the V-Wave Interatrial Shunt System.