V-Wave Interatrial Shunt for Pulmonary Hypertension

(RELIEVE-PAH Trial)

Recruiting in Columbus (>99 mi)

+2 other locations

Overseen by Victor Tapson, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: V-Wave Ltd

Must be taking: PAH therapy

Disqualifiers: Severe lung disease, Organ dysfunction, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The objectives of the RELIEVE-PAH study are to obtain first-in-human experience with the study device in patients with severe pulmonary arterial hypertension, including evidence of initial safety, device performance and possible signals of clinical effectiveness.

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 data supports the effectiveness of the V-Wave Interatrial Shunt treatment for pulmonary hypertension?

Research shows that the V-Wave device, used to create a small passage between heart chambers, can help reduce pressure in the heart and improve symptoms in patients with heart failure. This approach has been shown to improve heart function and quality of life, suggesting potential benefits for conditions like pulmonary hypertension. ^{1 2 3 4 5}

How is the V-Wave Interatrial Shunt treatment different from other treatments for pulmonary hypertension?

The V-Wave Interatrial Shunt is unique because it is a device implanted to create a small passage between the heart's upper chambers, allowing blood to flow from the left atrium to the right atrium, which helps reduce pressure in the left atrium and improve symptoms of pulmonary hypertension. This approach is different from traditional drug treatments as it directly addresses the pressure imbalance in the heart. ^{1 2 4 5 6}

Research Team

Victor Tapson, M.D.

Principal Investigator

Cedars-Sinai Medical Center

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• V-Wave Interatrial Shunt (Device)

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

[InterAtrial Shunt Device in diastolic heart failure]. [2019]

2. France 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. [2021]

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

Pulmonary hypertension after ventriculoatrial shunt implantation. [2016]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Development of pulmonary hypertension in adults after ventriculoatrial shunt implantation. [2009]

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

Creation of a restrictive atrial left-to-right shunt: a novel treatment for heart failure. [2019]

6. England 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. [2021]