What side effects are associated with this type of intervention?

Common treatments for heart failure, particularly those aimed at reducing pressure and volume overload like the V-Wave Interatrial Shunt System, include diuretics, ACE inhibitors, beta-blockers, and device-based therapies. Diuretics can cause electrolyte imbalances and dehydration. ACE inhibitors may lead to cough, elevated blood potassium levels, and kidney dysfunction. Beta-blockers can cause fatigue, bradycardia, and hypotension. Device-based therapies, such as pacemakers and shunt systems, may have procedural risks including infection, bleeding, and device malfunction.

What prior FDA approvals exist?

The FDA has approved several treatments for heart failure that aim to manage symptoms and improve heart function. These include medications such as beta-blockers, ACE inhibitors, ARBs, and diuretics, which help reduce the workload on the heart and manage fluid buildup. Devices like implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy (CRT) have also been approved to manage heart rhythm issues and improve heart function. While specific FDA approvals for devices similar to the V-Wave Interatrial Shunt System are not detailed, the concept of reducing atrial pressure and volume overload is aligned with the goals of these broader heart failure treatments.

What other types of research exist?

Promising novel alternatives to the V-Wave Interatrial Shunt System for heart failure patients include: 1) Cardiac contractility modulation (CCM) devices, which improve heart muscle contractions without increasing oxygen demand. 2) Baroreflex activation therapy (BAT), which stimulates baroreceptors to reduce sympathetic activity and improve heart function. 3) Left ventricular assist devices (LVADs), which mechanically support heart function in advanced heart failure. 4) Gene therapy approaches targeting specific molecular pathways involved in heart failure. These alternatives have shown potential in clinical trials and may offer new options for heart failure management in 2024.

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Device

Interatrial Shunt Device for Heart Failure (RELIEVE-HF Trial)

N/A

Waitlist Available

Led By Josep Rodés-Cabau, MD

Research Sponsored by V-Wave Ltd

Eligibility Criteria Checklist

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

Must have

Main

Receiving guideline directed medical and device therapy (GDMT) for heart failure

Must not have

Pulmonary hypertension with PASP of ≥70 mm/Hg or PVR > 4 WU

Moderate to severe aortic or mitral stenosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline through study completion, maximum of five years

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects aren't listed here, similar procedures may include risks such as bleeding at the access site, infection risk from implantation of a device into the body and potential complications related to heart rhythm.

Eligibility Criteria

Inclusion Criteria

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

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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?

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I am following recommended treatments for heart failure.

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My heart failure is moderate to severe but I can still walk.

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I have been hospitalized for heart failure in the last year or have high BNP/NT-proBNP levels.

Exclusion Criteria

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

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I have high blood pressure in the lungs.

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I have a serious narrowing of my heart's aortic or mitral valve.

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I have not had a stroke, TIA, or DVT in the last 6 months.

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My kidney function is very low.

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My veins are not suitable for a specific heart procedure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline through study completion, maximum of five years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline through study completion, maximum of five years

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through study completion, maximum of five years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Effectiveness-Hierarchical composite of death, heart transplant or left ventricular assist device (LVAD) implantation, HF hospitalizations, worsening HF events treated as an outpatient, and change in Kansas City Cardiomyopathy Questionnaire (KCCQ)

Safety-Percentage of Treatment patients experiencing major device-related adverse events

Secondary study objectives

6MWT changes

Cumulative heart failure hospitalizations

KCCQ changes

+4 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Group I: TreatmentExperimental Treatment1 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 inExperimental Treatment1 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: ControlExperimental Treatment1 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.

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

The V-Wave Interatrial Shunt System works by creating a controlled shunt between the atria, which helps to reduce pressure and volume overload in the heart. This mechanism is crucial for heart failure patients as it alleviates symptoms and improves cardiac function by preventing fluid buildup and reducing the strain on the heart. Other common treatments for heart failure include diuretics, which help remove excess fluid; beta-blockers and ACE inhibitors, which reduce the heart's workload and improve its efficiency; and devices like pacemakers and defibrillators that ensure proper heart rhythm and function. These treatments collectively aim to enhance quality of life and reduce hospitalizations for heart failure patients.

Role of Echocardiography for Assessment of Cardiac Remodeling in Congenitally Corrected Transposition of Great Arteries.Effects of adaptive servo-ventilation therapy on cardiac function and remodeling in patients with chronic heart failure (SAVIOR-C): study protocol for a randomized controlled trial.