Interatrial Shunt Device for Heart Failure

(RELIEVE-HF Trial)

Not currently recruiting at 129 trial locations

Overseen By Roger Gammon, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: V-Wave Ltd

Must be taking: Guideline-directed therapies

Disqualifiers: Hypertension, Thrombus, Stroke, others

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

Compensation: Varies

Number of Visits: 1

Duration: 30 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a device called the V-Wave Interatrial Shunt to determine if it can alleviate symptoms and improve health in people with certain types of heart failure. Heart failure reduces the heart's ability to pump blood efficiently, leading to symptoms like fatigue and shortness of breath. Participants will either receive the device or undergo a procedure to determine eligibility. Individuals with heart failure who regularly experience symptoms and are already on heart failure treatments might be suitable candidates for this study. As an unphased trial, this study provides an opportunity to contribute to innovative research that could enhance future heart failure treatments.

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 mentions that participants should be on guideline-directed medical and device therapy for heart failure, so you may need to continue your current heart failure treatments.

What prior data suggests that the V-Wave Interatrial Shunt is safe for heart failure patients?

Research has shown that the V-Wave Interatrial Shunt is generally safe for people with heart failure. In earlier studies, this shunt demonstrated a good safety record. Patients experienced fewer major heart-related problems after receiving the shunt. For instance, one study found that heart failure patients with reduced heart function had 45% fewer serious heart issues. Another study confirmed the shunt's safety and benefits for heart failure patients, regardless of their heart's pumping efficiency. While most patients did well, one person passed away shortly after the procedure due to other heart problems. Overall, these findings suggest the shunt is well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The V-Wave Interatrial Shunt is unique because it offers a new approach for managing heart failure by creating a small passage between the heart's atria to reduce pressure on the heart. Unlike standard treatments like medications and lifestyle changes that focus on symptom management, the V-Wave Shunt directly targets the heart's structure to improve blood flow and reduce stress on the heart. Researchers are excited about this treatment because it has the potential to significantly improve quality of life for patients with heart failure by directly addressing the condition's underlying causes rather than just alleviating symptoms.

What evidence suggests that the V-Wave Interatrial Shunt is effective for heart failure?

Research has shown that the V-Wave Interatrial Shunt can help people with heart failure by reducing symptoms and improving health outcomes. One study found that patients using the shunt experienced 45% fewer heart-related problems. The shunt creates a small opening between heart chambers, which lowers pressure in the left side of the heart and can relieve heart failure symptoms. In this trial, participants in the treatment and roll-in arms will receive the V-Wave Shunt. Other research indicates that this device is safe and effective for patients with different types of heart failure. This evidence suggests that the V-Wave Shunt could be a promising option for managing heart failure symptoms. ^{1 2 3 4 5}

Who Is on the Research Team?

Josep Rodés-Cabau, MD

Principal Investigator

Université Laval (CRIUCPQ-ULaval)

Gregg W Stone, MD

Principal Investigator

Colombia University Medical Center

Stefan D Anker, MD, PhD

Principal Investigator

University Medical Center Gottingen, Germany

JoAnn Lindenfeld, MD

Principal Investigator

Vanderbilt University

Are You a Good Fit for This Trial?

This trial is for heart failure patients who are following their treatment plans, have had a recent hospital stay or high BNP levels, and fall under NYHA Class II-IV. It's not for those with recent strokes, severe blood pressure issues, certain heart conditions like large left ventricles or valve stenosis, serious lung hypertension, poor kidney function, or if they can't physically receive the shunt.

Inclusion Criteria

It seems like there might be a mistake in your request. It looks like the criterion is incomplete. Can you provide more details or clarify?

I am following recommended treatments for heart failure.

I have heart failure, regardless of my heart's pumping ability.

Exclusion Criteria

Your right ventricle is not working well, based on specific measurements from a heart test.

You have a blood clot inside your heart.

I have high blood pressure in the lungs.

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 in the treatment arm undergo diagnostic right heart catheterization and V-Wave Shunt implantation

30 days

Multiple visits (in-person) for procedure and monitoring

Follow-up

Participants are monitored for safety and effectiveness, with follow-up visits for a minimum of 12 months to a maximum of 24 months

12-24 months

Regular visits (in-person) for monitoring

Long-term follow-up

All implanted patients will be followed for a total of 5 years from the time of the study device implantation

5 years

What Are the Treatments Tested in This Trial?

Interventions

• V-Wave Interatrial Shunt

Trial Overview The RELIEVE-HF study tests the V-Wave Interatrial Shunt System to see if it safely and effectively improves symptoms in people with different types of heart failure (with reduced or preserved ejection fraction) who are already on standard treatments.

How Is the Trial Designed?

Group I: Treatment 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

Group II: Roll in Experimental Treatment 1 Intervention

Roll in 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

Group III: Control Experimental Treatment 1 Intervention

Control arm patients will undergo a diagnostic right heart catheterization and invasive echocardiography to determine study eligibility, but will not have transseptal catheterization or shunt implantation.

Who Is Running the Clinical Trial?

V-Wave Ltd

Lead Sponsor

Trials

5

Recruited

650+

Published Research Related to This Trial

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38561314/

Outcomes from the open-label cohort of the RELIEVE-HF trial Interatrial shunting with the Ventura device was safe and resulted in favourable clinical effects in patients with HF, regardless of LVEF.

2. 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).

3. 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.

4. 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 ... Heart failure patients with reduced ejection (HFrEF) had 45% fewer adverse cardiovascular events, whereas patients with heart failure with preserved ejection ...

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 ... Procedural success was obtained in nine patients (90%); one patient died in the hours following the procedure due to an electrical storm unresponsive to medical ...