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 :
Active, not recruiting
First Posted : April 17, 2018
Last Update Posted : February 27, 2023
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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 | February 27, 2023 | ||||||||||||
Actual Study Start Date ICMJE | September 19, 2018 | ||||||||||||
Estimated Primary Completion Date | October 15, 2023 (Final data collection date for primary outcome measure) | ||||||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | |||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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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, 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 500 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. | ||||||||||||
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 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
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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 | Active, not recruiting | ||||||||||||
Actual Enrollment ICMJE |
605 | ||||||||||||
Original Estimated Enrollment ICMJE |
500 | ||||||||||||
Estimated Study Completion Date ICMJE | October 31, 2027 | ||||||||||||
Estimated Primary Completion Date | October 15, 2023 (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 | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
Listed Location Countries ICMJE | Australia, Belgium, Canada, Germany, Israel, Netherlands, New Zealand, Poland, Spain, Switzerland, United States | ||||||||||||
Removed Location Countries | Georgia | ||||||||||||
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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Current Responsible Party | V-Wave Ltd | ||||||||||||
Original Responsible Party | Same as current | ||||||||||||
Current Study Sponsor ICMJE | V-Wave Ltd | ||||||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||||||
Collaborators ICMJE | Not Provided | ||||||||||||
Investigators ICMJE |
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PRS Account | V-Wave Ltd | ||||||||||||
Verification Date | October 2022 | ||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |