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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 : May 4, 2020
Sponsor:
Information provided by (Responsible Party):
V-Wave Ltd

Tracking Information
First Submitted Date  ICMJE March 29, 2018
First Posted Date  ICMJE April 17, 2018
Last Update Posted Date May 4, 2020
Actual Study Start Date  ICMJE September 19, 2018
Estimated Primary Completion Date October 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 13, 2018)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 13, 2018)
  • Change in 6MWT [ Time Frame: Baseline to 12 months ]
    Comparison between Treatment and Control groups of change in 6MWT
  • Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) [ Time Frame: Baseline to 12 months ]
    Comparison between Treatment and Control groups of change in KCCQ
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Reducing Lung CongestIon Symptoms in Advanced Heart Failure
Official Title  ICMJE RELIEVE-HF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Heart Failure
Intervention  ICMJE
  • 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
    Right heart catheterization, invasive echocardiography.
Study Arms  ICMJE
  • 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
    Intervention: Device: V-Wave Interatrial Shunt
  • 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.
    Intervention: Other: Control
  • 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
    Intervention: Device: V-Wave Interatrial Shunt
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 13, 2018)
500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 1, 2025
Estimated Primary Completion Date October 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Karen Foley, RN +1(818)629-2164 karen@vwavemedical.com
Contact: Olivia Mishall, RN +972(77)3168550 olivia@vwavemedical.com
Listed Location Countries  ICMJE Belgium,   Canada,   Germany,   Israel,   Netherlands,   Poland,   Spain,   Switzerland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03499236
Other Study ID Numbers  ICMJE CL7018
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party V-Wave Ltd
Study Sponsor  ICMJE V-Wave Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account V-Wave Ltd
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP