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NCT03499236 · ClinicalTrials.gov registry record · NA
Reducing Lung CongestIon Symptoms in Advanced Heart Failure
A NA study of Heart Failure, sponsored by V-Wave.
- Active
- Registry status
- NA
- Development phase
- 605
- Enrollment target
- 20
- Study locations
NCT03499236: Active NA study of Heart Failure, sponsored by V-Wave.
NCT03499236 is a NA study of Heart Failure that is active but no longer recruiting, run by V-Wave. The registered enrollment target is 605 participants, below the 2,048-participant average among 397 other Heart Failure trials with a reported enrollment target (70% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03499236, a NA study of Heart Failure, is active but no longer recruiting, sponsored by V-Wave.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 605 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
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
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 |
What the registry record for NCT03499236 still lists
NCT03499236 is an interventional study that assigns participants to a tested intervention. The registered 605 participants enrollment target is mid-sized for trials with a published cap, below the 2,048-participant average among 397 other Heart Failure trials with a reported enrollment target (70% lower).
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.
NCT03499236 names 20 study sites across 7 states, led by California, Florida, Arizona.
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.
What interventions are being tested in trial NCT03499236?
The interventions under investigation include: Control (OTHER), V-Wave Interatrial Shunt (DEVICE).
Who is sponsoring clinical trial NCT03499236?
This trial is sponsored by V-Wave, which has 2 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Heart Failure
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03499236's enrollment target sits among peer trials
605 93rd of 397 higher than 304 of 397 other Heart Failure trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Heart Failure trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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