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Device

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

N/A
Waitlist Available
Led By Stefan D Anker, MD, PhD
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through study completion, maximum of five years
Awards & highlights

RELIEVE-HF Trial Summary

This trial is testing a new device to help people with heart failure who are not helped by other treatments.

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.Check my eligibility
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.See study design
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.

RELIEVE-HF Trial 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.

RELIEVE-HF Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
6MWT changes
Cumulative heart failure hospitalizations
KCCQ changes
+4 more

RELIEVE-HF 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.

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
Stefan D Anker, MD, PhDPrincipal InvestigatorUniversity Medical Center Gottingen, Germany
2 Previous Clinical Trials
3,241 Total Patients Enrolled
2 Trials studying Heart Failure
3,241 Patients Enrolled for Heart Failure
Josep Rodés-Cabau, MDPrincipal InvestigatorUniversité Laval (CRIUCPQ-ULaval)
5 Previous Clinical Trials
1,257 Total Patients Enrolled

Media Library

V-Wave Interatrial Shunt (Device) Clinical Trial Eligibility Overview. Trial Name: NCT03499236 — N/A
Heart Failure Clinical Trial 2023: V-Wave Interatrial Shunt Highlights & Side Effects. Trial Name: NCT03499236 — N/A
V-Wave Interatrial Shunt (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03499236 — N/A
Heart Failure Research Study Groups: Treatment, Control, Roll in

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the participant age range for this experiment restricted to over 20?

"This study mandates participant ages to exceed 18 years and be less than 99."

Answered by AI

Is this research taking on new participants at present?

"Verifying the information on clinicaltrials.gov, this scientific trial is not currently recruiting participants. The project was first published in September of 2018 and last updated in October 2022. Although inactive presently, there are 701 other studies actively canvassing for volunteers right now."

Answered by AI

What is the motivation behind this medical study?

"This clinical trial's main outcome, which is evaluated during the 12-24 month follow up period, is a 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). Secondary outcomes encompass KCCQ changes, time to all-cause death/ LVAD/Transplant/heart failure hospitalization and modified primary effectiveness endpoint including all-cause death /LVAD//Transplant/HF Hospitalizations /worsening HF events without use of KCCQ."

Answered by AI

Is there any potential for me to contribute to this research endeavor?

"This clinical trial is seeking 605 cardiac patients aged 18-99. To be eligible, they must meet the following conditions: NYHA Class II with past hospitalization and raised BNP/NT-ProBNP levels corrected for BMI; either Heart failure with Reduced Ejection Fraction (HFrEF) or Heart Failure with Preserved Ejection Fraction (HFpEF); receiving prescribed medical and device therapy for heart failure; NYHA Class III or ambulatory class IV HF, having experienced at least one prior hospitalisation within the last year; a BNP level of 300 pg/ml minimum or NT-proBNP level"

Answered by AI

In what number of healthcare facilities is this trial being conducted?

"This research project is currently open to applicants at Austin Heart in Austin, Tennessee, Ascension St. Thomas West in Nashville, Virginia and Methodist Hospital in San Antonio, Ohio. Additionally, 65 other clinical centres are participating."

Answered by AI

Who else is applying?

What state do they live in?
Tennessee
How old are they?
18 - 65
What site did they apply to?
Vanderbilt University Medical Center
Baylor Heart and Vascular-Dallas (Scott and White)
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I am trying everything and my EF is 20-25 Latest BNP IS 1100 I am currently a patient at the Medical City Heart Hospital Advanced Heart Failure Clinic.
PatientReceived 2+ prior treatments

How responsive is this trial?

Typically responds via
Email
Recent research and studies
clinicaltrials.govStudy
Reducing Lung CongestIon Symptoms in Advanced Heart Failure
2018. "Reducing Lung CongestIon Symptoms in Advanced Heart Failure". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03499236.
All > Heart Failure
~92 spots leftby Apr 2025
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