Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Reducing Lung CongestIon Symptoms in Advanced Heart Failure
NCT03499236 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- OTHER Control
- DEVICE V-Wave Interatrial Shunt
Study Locations (20)
California
- Scripps Health — La Jolla
- Long Beach Memorial Medical Center — Long Beach
- Keck Medical Center of USC — Los Angeles
- Cedars Sinai Medical Center — Los Angeles
- Kaiser Permanente San Francisco — San Francisco
- University of California, San Francisco — San Francisco
- Stanford Hospital — Stanford
- Los Robles Hospital & Medical Center — Thousand Oaks
- The Lundquist Institute (Harbor-UCLA) Medical Center — Torrance
Florida
- Memorial Hospital — Jacksonville
- University of Miami — Miami
- First Coast Cardiovascular Institute — Orange Park
Arizona
- Abrazo Arizona Heart Hospital — Phoenix
- Arizona Heart Rhythm Center — Phoenix
Georgia
- Piedmont Hospital — Atlanta
- Northeast Georgia Medical Center — Gainesville
Illinois
- Rush University Medical Center — Chicago
- Midwest Cardiovascular Institute — Naperville
Colorado
- South Denver Cardiology — Littleton
Kentucky
- St Elizabeth Medical Center — Edgewood
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 605 participants |
| Start Date | 2018-09-19 |
| Est. Completion | 2027-10-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03499236
The ClinicalTrials.gov registry entry for NCT03499236 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 605 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is V-Wave, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Heart Failure appearing as the primary indexed condition, and to 2 interventions — of which Control is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03499236 reports 20 study locations spanning 7 distinct geographic areas — top geographies include California, Florida, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03499236 about?
NCT03499236 is a clinical study titled "Reducing Lung CongestIon Symptoms in Advanced Heart Failure". 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 failur...
What is the current status of trial NCT03499236?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 605 participants. The study started on 2018-09-19. Estimated completion is 2027-10-31.
What conditions does trial NCT03499236 study?
This clinical trial studies the following conditions: Heart Failure. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03499236?
The interventions under investigation include: Control (OTHER), V-Wave Interatrial Shunt (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03499236?
This trial is sponsored by V-Wave, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03499236 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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