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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 belowSelect...
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:Select...
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
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 moreAwards & 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.
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.
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.
Find a Location
Who is running the clinical trial?
V-Wave LtdLead Sponsor
4 Previous Clinical Trials
46 Total Patients Enrolled
3 Trials studying Heart Failure
26 Patients Enrolled for Heart Failure
Josep Rodés-Cabau, MDPrincipal InvestigatorUniversité Laval (CRIUCPQ-ULaval)
6 Previous Clinical Trials
1,407 Total Patients Enrolled
Gregg W Stone, MDPrincipal InvestigatorColombia University Medical Center
15 Previous Clinical Trials
20,465 Total Patients Enrolled
1 Trials studying Heart Failure
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your right ventricle is not working well, based on specific measurements from a heart test.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?You have a blood clot inside your heart.I have high blood pressure in the lungs.Your blood pressure is too low (less than 90) or too high (more than 160).Your heart has a physical abnormality that makes it impossible to place a shunt in a specific part of the heart.You have unstable heart rhythm or breathing at the time of the final screening.I have a serious narrowing of my heart's aortic or mitral valve.I have not had a stroke, TIA, or DVT in the last 6 months.My kidney function is very low.My veins are not suitable for a specific heart procedure.I am following recommended treatments for heart failure.I have heart failure, regardless of my heart's pumping ability.I have heart issues, was hospitalized for them, and have high BNP levels.My heart failure is moderate to severe but I can still walk.Your heart's left ventricle is larger than 8 centimeters when it is full of blood.I have been hospitalized for heart failure in the last year or have high BNP/NT-proBNP levels.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment
- Group 2: Control
- Group 3: Roll in