Trial record 1 of 1 for:
NCT03499236
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 : January 22, 2021
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Sponsor:
V-Wave Ltd
Information provided by (Responsible Party):
V-Wave Ltd
Tracking Information | |||||||||||||
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First Submitted Date ICMJE | March 29, 2018 | ||||||||||||
First Posted Date ICMJE | April 17, 2018 | ||||||||||||
Last Update Posted Date | January 22, 2021 | ||||||||||||
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 |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||
Change History | |||||||||||||
Current Secondary Outcome Measures ICMJE |
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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 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 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
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Condition ICMJE | Heart Failure | ||||||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||
Recruitment Status ICMJE | Recruiting | ||||||||||||
Estimated Enrollment ICMJE |
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:
Main Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 99 Years (Adult, Older Adult) | ||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||
Contacts ICMJE |
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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 |
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IPD Sharing Statement ICMJE |
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Responsible Party | V-Wave Ltd | ||||||||||||
Study Sponsor ICMJE | V-Wave Ltd | ||||||||||||
Collaborators ICMJE | Not Provided | ||||||||||||
Investigators ICMJE |
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PRS Account | V-Wave Ltd | ||||||||||||
Verification Date | January 2021 | ||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |