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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03499236
Recruitment Status : Recruiting
First Posted : April 17, 2018
Last Update Posted : November 25, 2019
Sponsor:
Information provided by (Responsible Party):
V-Wave Ltd

Brief Summary:
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 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.

Condition or disease Intervention/treatment Phase
Heart Failure Device: V-Wave Interatrial Shunt Other: Control Not Applicable

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 400 patients will be randomized. Patients 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 once unblinded, 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized treatment versus control (1:1). Control patients will be allowed to cross-over at the completion of the blinded phase. A parallel roll-in arm will enroll up to 3 patients per site in an open-label study.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: In the randomized cohort, participants and the heart failure clinical team will be blinded to study assignment.
Primary Purpose: Treatment
Official Title: RELIEVE-HF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure
Actual Study Start Date : September 19, 2018
Estimated Primary Completion Date : October 1, 2021
Estimated Study Completion Date : May 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
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.

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.




Primary Outcome Measures :
  1. 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

  2. Effectiveness-Hierarchical composite of death, heart transplant or left ventricular assist device (LVAD) implantation, HF hospitalizations, and change in six minute walk test (6MWT). [ 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


Secondary Outcome Measures :
  1. Change in 6MWT [ Time Frame: Baseline to 12 months ]
    Comparison between Treatment and Control groups of change in 6MWT

  2. Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) [ Time Frame: Baseline to 12 months ]
    Comparison between Treatment and Control groups of change in KCCQ



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Main Inclusion Criteria:

  • Both heart failure with reduced ejection fraction (HFrEF) and heart failure with preserved ejection fraction (HFpEF) patients
  • NYHA Class III or ambulatory Class IV HF
  • Receiving guideline directed medical therapy (GDMT) for heart failure
  • 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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03499236


Contacts
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Contact: Karen Foley, RN +1(818)629-2164 karen@vwavemedical.com
Contact: Olivia Mishall, RN +972(77)3168550 olivia@vwavemedical.com

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Locations
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United States, California
Central Cardiology Medical Center Recruiting
Bakersfield, California, United States, 93308
Contact: Sanjiv Sharma, MD         
Scripps Health Recruiting
La Jolla, California, United States, 92037
Contact: Matthew Price, MD         
Keck Medical Center of USC Recruiting
Los Angeles, California, United States, 90033
Contact: David Shavelle, MD         
Cedars Sinai Medical Center Recruiting
Los Angeles, California, United States, 90211
Contact: Raj Makar, MD         
Foundation for Cardiovascular Medicine Recruiting
San Diego, California, United States, 92122
Contact: Maurice Buchbinder, MD         
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Liviu Klein, MD         
United States, Florida
JFK Medical Center Recruiting
Atlantis, Florida, United States, 33462
Contact: Waqas Ghumman, MD         
Morton Plant Mease Healthcare Recruiting
Clearwater, Florida, United States, 33756
Contact: Leslie Miller, MD         
Contact: Lang Lin, MD         
Memorial Hospital Recruiting
Jacksonville, Florida, United States, 32216
Contact: Sumant Lamba, MD         
University of Miami Hosptial Recruiting
Miami, Florida, United States, 33136
Contact: Mauricio Cohen, MD         
United States, Illinois
Advocate Health and Hospitals Corporation (Edwards Hospital) Recruiting
Naperville, Illinois, United States, 60540
Contact: Maria Rosa Costanzo, MD         
United States, Kentucky
St Elizabeth Medical Center Recruiting
Edgewood, Kentucky, United States, 41017
Contact: Saeb Khoury, MD         
United States, Minnesota
United Heart & Vascular Clinic Recruiting
Saint Paul, Minnesota, United States, 55102
Contact: Alan Bank, MD         
United States, Nebraska
Nebraska Heart Institute Recruiting
Lincoln, Nebraska, United States, 68526
Contact: Steven Krueger, MD         
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467
Contact: Giora Weisz, MD         
Weill Cornell Recruiting
New York, New York, United States, 10065
Contact: Maria Karas, MD         
Rochester General Health System Recruiting
Rochester, New York, United States, 14621
Contact: Scott Feitell, DO         
Contact: Jeremiah Depta, MD         
University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Contact: Leway Chen, MD         
Contact: Fred Ling, MD         
United States, North Carolina
Wakemed Recruiting
Raleigh, North Carolina, United States, 27610
Contact: Stuart Russell, MD         
United States, Ohio
Lindner Center for Research and Education at The Christ Hospital Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Eugene Chung, MD         
The Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Garrie Haas, MD         
United States, Tennessee
Centennial Medical Center Recruiting
Nashville, Tennessee, United States, 37203
Contact: Tom McRae, MD         
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Lynn Punnose, MD         
United States, Texas
Austin Heart Recruiting
Austin, Texas, United States, 78756
Contact: Juhana Karha, MD         
Contact: Roger Gammon, MD         
Medical City Dallas Recruiting
Dallas, Texas, United States, 75230
Contact: Jacob Chemmalakuzhy, MD         
United States, Virginia
Chippenham Medical Center Recruiting
Richmond, Virginia, United States, 23225
Contact: Andrew Keller, MD         
Belgium
Antwerp Cardiovascular Center, ZNA Middelheim Hospital Recruiting
Antwerp, Belgium
Contact: Edgard Prihadi, MD         
Saint Luc Hospital Recruiting
Brussel, Belgium
Contact: Joelle Kefer, Prof         
Canada
McGill University Recruiting
Montréal, Canada, H4A 3J1
Contact: Nadia Giannetti, MD         
Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval Recruiting
Québec, Canada, G1V 4G5
Contact: Josep Rodés-Cabau, MD         
Germany
Vivantes Klinikum Urban Recruiting
Berlin, Germany
Contact: Huseyin Ince, Prof         
Marienkrankrankenhas Recruiting
Hamburg, Germany
Contact: Marien Schafer, Prof         
University of Rostock Recruiting
Rostock, Germany
Contact: Huseyin Ince, Prof         
Israel
Yitzhak Shamir Medical Center Recruiting
Be'er Ya'aqov, Israel
Contact: Gil Moravski, MD         
Shaare Zedek Medical Center Recruiting
Jerusalem, Israel, 9103102
Contact: Yaron Almagor, Dr.    972-2-6555975    almagor@szmc.org.il   
Contact: Tal Hasin, Dr.    972-5-7558415    hasint@szmc.org.il   
Hadassah Medical Center Recruiting
Jerusalem, Israel
Contact: Haim Danenberg, MD         
The Chaim Sheba Medical Center Tel-Hashomer Recruiting
Ramat Gan, Israel, 52621
Contact: Dov Freimark, Prof.    972-3-5302645    dov.freimark@sheba.health.gov.il   
Contact: Michael Shechter, Prof.    972-523-599384    Michael.Shechter@sheba.health.gov.il   
Tel Aviv Sourasky Medical Center Recruiting
Tel Aviv, Israel
Contact: Michal Laufer Perl, MD         
The Baruch Padeh Medical Center, Poriya Recruiting
Tiberias, Israel, 15208
Contact: Offer Amir, Prof.    972-4-6652648    OAmir@poria.health.gov.il   
Netherlands
St Antonius Ziekenhuis Nieuwegein Recruiting
Nieuwegein, Utrecht, Netherlands, 3435
Contact: Martijn Cornelis) Post, Dr.    + 31-30-6099111    m.post@antoniusziekenhuis.nl   
Contact: Mike Amoud Ramon Bosschaert, Dr.    +31 88 32 00900    m.bosschaert@antoniusziekenhuis.nl   
Academic Medical Center, The Netherlands Recruiting
Amsterdam, Netherlands, 1105
Contact: Robbert de Winter, Prof.    +31 20 566 6406    r.j.dewinter@amc.uva.nl   
Contact: Rutger Feenstra, Dr.    +31 20 566 6405    r.g.feenstra@amc.uva.nl   
Poland
University Hospital in Krakow Recruiting
Kraków, Poland
Contact: Dariusz Dudek, Prof         
Institute of Cardiology, Warsaw Recruiting
Warsaw, Poland
Contact: Andrzej Witkowski, Prof         
Military Clinical Hospital Recruiting
Wrocław, Poland
Contact: Bartosz Krakowiak, MD         
University Hospital Wroclaw Recruiting
Wrocław, Poland
Contact: Adam Kolodziej, MD         
Spain
Hospital Universitari Germans Trias i Pujol, Badalona Barcelona Recruiting
Barcelona, Spain, 08916
Contact: Antoni Bayes-Genis, Prof.    34 934978915    abayesgenis@gmail.com   
Hospital Clínico San Carlos Recruiting
Madrid, Spain, 28040
Contact: Luis Nombela Franco, Dr.    34 629510139    luisnombela@yahoo.com   
Contact: Maria del Trigo, Dr.    34913303438    mariadeltrigo@hotmail.com   
Hospital Clínico Universitario de Valencia Recruiting
Valencia, Spain, 46010
Contact: Julio Núñez Villota, Dr.    +34963862600    yulnunez@gmail.com   
Hospital Clínico Universitario de Valladolid Recruiting
Valladolid, Spain, 47003
Contact: Ignacio Amat Santos, Dr/    34 983420026    ijamat@gmail.com   
Contact: Javier Tobar Diaz, Dr.    34 983420026    javitobar10@gmail.com   
Sponsors and Collaborators
V-Wave Ltd
Investigators
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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

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Responsible Party: V-Wave Ltd
ClinicalTrials.gov Identifier: NCT03499236     History of Changes
Other Study ID Numbers: CL7018
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: November 25, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases