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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 9, 2021
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 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.

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 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.

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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 2 patients per site in an open-label study.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: In the randomized cohort, participants, the clinical team, and research staff managing the patient after randomization 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 : December 31, 2022
Estimated Study Completion Date : December 31, 2026

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 Kansas City Cardiomyopathy Quesstionnaire (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


Secondary Outcome Measures :
  1. 6MWT changes [ Time Frame: Baseline to 12 months ]
    6MWT changes

  2. KCCQ changes [ Time Frame: Baseline to 12 months ]
    KCCQ changes

  3. KCCQ changes [ Time Frame: Baseline through study completion, maximum of five years ]
    KCCQ changes

  4. 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

  5. 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

  6. Cumulative heart failure hospitalizations [ Time Frame: Baseline through study completion, maximum of five years ]
    Cumulative heart failure hospitalizations

  7. Time to first heart failure hospitalization [ Time Frame: Baseline through study completion, maximum of five years ]
    Time to first heart failure hospitalization

  8. Modified Primary Effectiveness Endpoint including all-cause death, LVAD/Transplant and HF Hospitalizations but without KCCQ [ Time Frame: Baseline through study completion, maximum of five years ]
    Modified Primary Effectiveness Endpoint including all-cause death, LVAD/Transplant and HF Hospitalizations but without 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 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

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

Locations
Show Show 124 study locations
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    
Other Study ID Numbers: CL7018
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: November 9, 2021
Last Verified: July 2021
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
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases