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

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ClinicalTrials.gov Identifier: NCT03499236
Recruitment Status : Recruiting
First Posted : April 17, 2018
Last Update Posted : October 4, 2018
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.

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



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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 ≤30%
  • 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
Contact: Russell Ivanhoe, MD +1(818)629-2164 russell@vwavemedical.com
Contact: Olivia Mishall, RN +972(77)3168550 olivia@vwavemedical.com

Locations
United States, Ohio
The Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Garrie Haas, MD         
Canada
Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval Recruiting
Québec, Canada, G1V 4G5
Contact: Josep Rodés-Cabau, MD         
Israel
Hadassah Medical Center Recruiting
Jerusalem, Israel
Contact: Haim Danenberg, MD         
Tel Aviv Sourasky Medical Center Recruiting
Tel Aviv, Israel
Contact: Michal Laufer, MD         
Sponsors and Collaborators
V-Wave Ltd
Investigators
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

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: October 4, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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:
Heart Failure
Heart Diseases
Cardiovascular Diseases