Interatrial Shunt Device for Heart Failure

(RELIEVE-HF Trial)

Recruiting at 122 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

605 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a small device placed in the heart to help patients with severe heart failure symptoms. It aims to improve their condition by balancing heart pressure and making it easier for the heart to pump blood.

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 data supports the effectiveness of the V-Wave Interatrial Shunt treatment for heart failure?

Research shows that the V-Wave device, which creates a small passage between the heart's upper chambers, can help lower pressure in the left atrium (upper left heart chamber) and improve symptoms in patients with heart failure. Studies have found that this treatment can enhance physical performance and quality of life by reducing stress on the heart. ^{1 2 3 4 5}

Is the V-Wave Interatrial Shunt device safe for use in humans?

The V-Wave Interatrial Shunt device has been shown to be safe in several clinical studies, with low risk and few complications reported. It is designed to help manage heart failure by reducing pressure in the heart, and has been used successfully in patients with different types of heart failure. ^{1 2 3 4 6}

How is the V-Wave Interatrial Shunt treatment different from other heart failure treatments?

The V-Wave Interatrial Shunt is unique because it creates a small passage between the left and right atria of the heart to reduce pressure in the left atrium, which can help prevent fluid buildup in the lungs and improve symptoms in heart failure patients. This approach is different from traditional treatments as it directly addresses the pressure imbalance in the heart rather than just managing symptoms. ^{1 2 3 4 6}

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. 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]

2. Germany pubmed.ncbi.nlm.nih.gov

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

3. United Arab Emirates pubmed.ncbi.nlm.nih.gov

State-of-the-Art Review of Current Therapies for HFpEF: An Overview of Interatrial Septal Device Therapy in Heart Failure. [2022]

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

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

5. England pubmed.ncbi.nlm.nih.gov

Atrial shunt device for heart failure with preserved and mildly reduced ejection fraction (REDUCE LAP-HF II): a randomised, multicentre, blinded, sham-controlled trial. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Interatrial Shunting for Treating Acute and Chronic Left Heart Failure. [2020]