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

• ClinicalTrials.gov Identifier: NCT03499236
• Recruitment Status: Recruiting
• First Posted: April 17, 2018
• Last Update Posted: January 22, 2021
• Sponsor: V-Wave Ltd
• Information provided by (Responsible Party): V-Wave Ltd

Tracking Information

• First Submitted Date: March 29, 2018
• First Posted Date: April 17, 2018
• Last Update Posted Date: January 22, 2021
• Actual Study Start Date: September 19, 2018
• Estimated Primary Completion Date: October 1, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Reducing Lung CongestIon Symptoms in Advanced Heart Failure
• Official Title: 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 II/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: Interventional
• Study Phase: Not Applicable

Study Design

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: Heart Failure

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: April 13, 2018): 500
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: May 1, 2025
• Estimated Primary Completion Date: October 1, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

Main Inclusion Criteria:

• Both heart failure with reduced ejection fraction (HFrEF) and heart failure with preserved ejection fraction (HFpEF) patients
• NYHA Class II/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

• Sexes Eligible for Study: All

• Ages: 18 Years to 99 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Karen Foley, RN; +1(818)629-2164; karen@vwavemedical.com

Contact: Olivia Mishall, RN; +972(77)3168550; olivia@vwavemedical.com

• Listed Location Countries: Belgium, Canada, Germany, Israel, Netherlands, Poland, Spain, Switzerland, United States

Administrative Information

• NCT Number: NCT03499236
• Other Study ID Numbers: 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

• Plan to Share IPD: Undecided

• Responsible Party: V-Wave Ltd
• Study Sponsor: V-Wave Ltd
• Collaborators: Not Provided

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

• PRS Account: V-Wave Ltd
• Verification Date: January 2021