Reducing Lung CongestIon Symptoms in Advanced Heart Failure (RELIEVE-HF)

August 18, 2025 updated by: V-Wave Ltd

RELIEVE-HF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure

The objective of the RELIEVE-HF study is to provide reasonable assurance of safety and effectiveness of the V-Wave Interatrial Shunt System by improving meaningful clinical outcomes in patients with New York Heart Association (NYHA) functional Class II, Class III, or ambulatory Class IV heart failure (HF), irrespective of left ventricular ejection fraction, who at baseline are treated with guideline-directed drug and device therapies.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a prospective, multi-center, 1:1 randomized, patient and observer blinded clinical study, with a Shunt Treatment arm and a non-implant Control arm. A total of approximately 500 patients will be randomized. Patients and all research staff managing the patients after randomization will be blinded during follow-up for a minimum of 12 months to a maximum of 24 months. Control patients will have the opportunity to receive a shunt after 24 months once unblinding occurs, if they provide consent, and continue to meet inclusion/exclusion criteria. All implanted patients will be followed for a total of 5 years from the time of the study device implantation.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
605

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Adelaide, Australia
        • Flinders Medical Centre
      • Brisbane, Australia
        • Prince Charles Hospital
      • Melbourne, Australia
        • St. Vincent's Hospital
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • St. Vincent's Hospital Sydney
  • Belgium
      • Antwerp, Belgium
        • Ziekenhuis Aan De Stroom vzw (ZAS)
      • Brugge, Belgium
        • AZ Sint-Jan Brugge
  • Canada
      • Montréal, Canada
        • Montreal Heart Institute
      • Québec, Canada, G1V 4G5
        • Institut universitaire de cardiologie et de pneumologie de Quebec - Universite Laval
  • Germany
      • Berlin, Germany, 10249
        • Vivantes Klinikum im Friedrichshain
      • Berlin, Germany, 10117
        • Charité - Universitätsmedizin Berlin Campus Virchow-Klinikum
      • Berlin, Germany
        • Vivantes Klinikum Urban
      • Hamburg, Germany
        • Marienkrankrankenhas
      • Leipzig, Germany, 04103
        • Universitätsklinikum Leipzig
      • Leipzig, Germany, 04289
        • Herzzentrum Leipzig
      • München, Germany, 81377
        • Ludwig-Maximilians-Universität München
      • Remscheid, Germany
        • SANA Remscheid
      • Rostock, Germany
        • University of Rostock
  • Israel
      • Ashdod, Israel, 7747629
        • University Hospital Samson Assuta Ashdod
      • Be'er Ya'aqov, Israel
        • Yitzhak Shamir Medical Center
      • Jerusalem, Israel
        • Hadassah Medical Center
      • Ramat Gan, Israel, 52621
        • The Chaim Sheba Medical Center Tel-Hashomer
      • Rechovot, Israel
        • Kaplan Medical Center
      • Tel Aviv, Israel
        • Tel Aviv Sourasky Medical Center
      • Tiberias, Israel, 15208
        • The Baruch Padeh Medical Center, Poriya
  • Netherlands
      • Amsterdam, Netherlands, 1105
        • Academic Medical Center, The Netherlands
      • Rotterdam, Netherlands, 3015
        • Erasmus University Medical Center Rotterdam
    • Utrecht
      • Nieuwegein, Utrecht, Netherlands, 3435
        • St Antonius Ziekenhuis Nieuwegein
  • New Zealand
      • Christchurch, New Zealand
        • Christchurch Hospital
  • Poland
      • Warszawa, Poland
        • Institute of Cardiology, Warsaw
      • Wrocław, Poland
        • The 4th Military Clinical Hospital Wroclaw
      • Wrocław, Poland
        • University Hospital Wroclaw
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic of Barcelona
      • Barcelona, Spain, 08041
        • Hospital De La Santa Creu I Sant Pau
      • Barcelona, Spain, 08916
        • Hospital Universitari Germans Trias i Pujol, Badalona Barcelona
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos
      • Madrid, Spain, 28222
        • hospital Puerta de Hierro-Majadahonda
      • Valencia, Spain, 46010
        • Hospital Clinico Universitario de Valencia
      • Valladolid, Spain, 47003
        • Hospital Clinico Universitario de Valladolid
  • Switzerland
      • Bern, Switzerland, 3010
        • Bern University Hospital
      • Zürich, Switzerland, 8091
        • University Hospital of Zurich
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Arizona Heart Rhythm Center
      • Phoenix, Arizona, United States, 85016
        • Abrazo Arizona Heart Hospital
    • California
      • La Jolla, California, United States, 92037
        • Scripps Health
      • Long Beach, California, United States, 90806
        • Long Beach Memorial Medical Center
      • Los Angeles, California, United States, 90033
        • Keck Medical Center of USC
      • Los Angeles, California, United States, 90211
        • Cedars Sinai Medical Center
      • San Francisco, California, United States, 94143
        • University of California, San Francisco
      • San Francisco, California, United States, 94118
        • Kaiser Permanente San Francisco
      • Stanford, California, United States, 94305
        • Stanford Hospital
      • Thousand Oaks, California, United States, 91360
        • Los Robles Hospital & Medical Center
      • Torrance, California, United States, 90502
        • The Lundquist Institute (Harbor-UCLA) Medical Center
    • Colorado
      • Littleton, Colorado, United States, 80120
        • South Denver Cardiology
    • Florida
      • Jacksonville, Florida, United States, 32216
        • Memorial Hospital
      • Miami, Florida, United States, 33136
        • University of Miami
      • Orange Park, Florida, United States, 32003
        • First Coast Cardiovascular Institute
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Piedmont Hospital
      • Gainesville, Georgia, United States, 30501
        • Northeast Georgia Medical Center
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Naperville, Illinois, United States, 60540
        • Midwest Cardiovascular Institute
    • Kentucky
      • Edgewood, Kentucky, United States, 41017
        • St Elizabeth Medical Center
    • Minnesota
      • Saint Paul, Minnesota, United States, 55102
        • United Heart & Vascular Clinic
    • Nebraska
      • Lincoln, Nebraska, United States, 68526
        • Nebraska Heart Institute
    • New Jersey
      • Ridgewood, New Jersey, United States, 07450
        • Valley Health System
    • New York
      • New York, New York, United States, 10065
        • Weill Cornell
      • Rochester, New York, United States, 14621
        • Rochester General Health System
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Mission Hospital
      • Raleigh, North Carolina, United States, 27607
        • North Carolina Heart & Vascular
    • Ohio
      • Akron, Ohio, United States, 44304
        • Summa Health
      • Cincinnati, Ohio, United States, 45219
        • Lindner Center for Research and Education at The Christ Hospital
      • Cleveland, Ohio, United States, 80120
        • Cleveland Clinic
      • Columbus, Ohio, United States, 43210
        • The Ohio State University
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Milton S. Hershey Medical Center
      • Wormleysburg, Pennsylvania, United States, 17043
        • UPMC Pinnacle / Pinnacle Health Cardiovascular Institute
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Centennial Medical Center
    • Texas
      • Austin, Texas, United States, 78756
        • Austin Heart
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
      • Houston, Texas, United States, 77030
        • Texas Heart Institute
      • Houston, Texas, United States, 77030
        • University of Texas Memorial Hermann
      • San Antonio, Texas, United States, 78249
        • Methodist Hospital
      • Tyler, Texas, United States, 75701
        • Christus Mother Frances Hospital
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah Hospital
    • Virginia
      • Richmond, Virginia, United States, 23225
        • Chippenham Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Main Inclusion Criteria:

  • Both heart failure with reduced ejection fraction (HFrEF) and heart failure with preserved ejection fraction (HFpEF) patients
  • NYHA Class II, Class III, or ambulatory Class IV HF
  • Receiving guideline directed medical and device therapy (GDMT) for heart failure
  • For NYHA Class III and ambulatory Class IV, at least one prior hospitalization for heart failure within the last year or elevated BNP level of at least 300 pg/ml or NT-proBNP level of at least 1,500 pg/ml. BNP/NT-ProBNP levels corrected for BMI
  • For NYHA Class II, must have both hospitalization and elevated BNP levels as above specifications

Main Exclusion Criteria:

  • Systolic blood pressure <90 or >160 mmHg
  • Presence of Intracardiac thrombus
  • Pulmonary hypertension with PASP of ≥70 mm/Hg or PVR > 4 WU
  • Significant RV dysfunction - TAPSE <12mm or RVFAC ≤25%
  • Left Ventricular End-Diastolic Diameter (LVEDD) >8cm
  • Moderate to severe aortic or mitral stenosis
  • Stroke or TIA or DVT within the last 6 months
  • eGFR <25 ml/min/1.73 m^2
  • Anatomical anomaly on TEE or ICE that precludes implantation of Shunt across fossa ovalis (FO) of the interatrial septum
  • Inadequate vascular access for implantation of shunt, e.g. femoral venous access for transseptal catheterization and inferior vena cava (IVC) is not patent
  • Hemodynamic heart rhythm, or respiratory instability at time of Final Exclusion Criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment
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
Device: V-Wave Interatrial Shunt
The V-Wave Interatrial Shunt System, includes a permanent implant placed during a minimally invasive cardiac catheterization procedure using its dedicated Delivery Catheter. The device is implanted through the fossa ovalis and straddles the interatrial septum.
Other: Control
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.
Other: Control
Right heart catheterization, invasive echocardiography.
Experimental: Roll in
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
Device: V-Wave Interatrial Shunt
The V-Wave Interatrial Shunt System, includes a permanent implant placed during a minimally invasive cardiac catheterization procedure using its dedicated Delivery Catheter. The device is implanted through the fossa ovalis and straddles the interatrial septum.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Safety-Percentage of Treatment patients experiencing major device-related adverse events
Time Frame: 30-days after randomization
Percentage of Treatment group patients experiencing any device-related Major Adverse Cardiovascular or Neurological Events (MACNE) during the first 30-days after randomization, compared to a pre-specified Performance Goal
30-days after randomization
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)
Time Frame: Follow-up duration at endpoint analysis ranges from a minimum of 12 to a maximum of 24 months
Treatment and Control groups will be compared using the Finkelstein-Schoenfeld method
Follow-up duration at endpoint analysis ranges from a minimum of 12 to a maximum of 24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
6MWT changes
Time Frame: Baseline to 12 months
6MWT changes
Baseline to 12 months
KCCQ changes
Time Frame: Baseline to 12 months
KCCQ changes
Baseline to 12 months
KCCQ changes
Time Frame: Baseline through study completion, maximum of five years
KCCQ changes
Baseline through study completion, maximum of five years
Time to all-cause death, LVAD/Transplant, or heart failure hospitalization
Time Frame: Baseline through study completion, maximum of five years
Time to all-cause death, LVAD/Transplant, or heart failure hospitalization
Baseline through study completion, maximum of five years
Time to all-cause death or first heart failure hospitalization
Time Frame: Baseline through study completion, maximum of five years
Time to all-cause death or first heart failure hospitalization
Baseline through study completion, maximum of five years
Cumulative heart failure hospitalizations
Time Frame: Baseline through study completion, maximum of five years
Cumulative heart failure hospitalizations
Baseline through study completion, maximum of five years
Time to first heart failure hospitalization
Time Frame: Baseline through study completion, maximum of five years
Time to first heart failure hospitalization
Baseline through study completion, maximum of five years
Modified Primary Effectiveness Endpoint including all-cause death, LVAD/Transplant, HF Hospitalizations, and worsening HF events treated as outpatient but without KCCQ
Time Frame: Baseline through study completion, maximum of five years
Modified Primary Effectiveness Endpoint including all-cause death, LVAD/Transplant, HF Hospitalizations, and worsening HF events treated as outpatient but without KCCQ
Baseline through study completion, maximum of five years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
V-Wave Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Stefan D Anker, MD, PhD, University Medical Center Gottingen, Germany
  • Principal Investigator: JoAnn Lindenfeld, MD, Vanderbilt University
  • Principal Investigator: Josep Rodés-Cabau, MD, Université Laval (CRIUCPQ-ULaval)
  • Principal Investigator: Gregg W Stone, MD, Colombia University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 19, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 9, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 29, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 17, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 19, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CL7018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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