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RESPONDER-HF Trial
NCT05425459 · View on ClinicalTrials.gov ↗
Study Summary
Multicenter, Prospective, Randomized, Sham Controlled, Double Blinded Clinical Trial, with; 1:1 randomization
Conditions Studied
Interventions
- DEVICE Corvia Atrial Shunt System / IASD System II
- OTHER Intra-cardiac echocardiography (ICE), or transesophageal echocardiography (TEE)
Study Locations (20)
Florida
- Memorial Regional Hospital — Hollywood
- NCH Naples — Naples
- Cleveland Clinic Florida — Weston
Illinois
- Northwestern University — Chicago
- University of Chicago Medical Center — Chicago
- Endeavor Health-Northshore — Glenview
California
- Scripps Clinic — La Jolla
- MemorialCare Long Beach Medical Center — Long Beach
Georgia
- Northside Hospital Gwinnett Campus — Lawrenceville
- Wellstar Kennestone — Marietta
Massachusetts
- Lahey Hospital & Medical Center — Burlington
- UMass Memorial Hospital University Campus — Worcester
Arizona
- Arizona Cardiovascular Research Center — Phoenix
Delaware
- Christiana Care Health Services — Newark
Louisiana
- LSU Health Shreveport — Shreveport
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 750 participants |
| Start Date | 2022-11-17 |
| Est. Completion | 2031-03 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05425459
The ClinicalTrials.gov registry entry for NCT05425459 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 750 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Corvia Medical, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Heart Failure appearing as the primary indexed condition, and to 2 interventions — of which Corvia Atrial Shunt System / IASD System II 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: NCT05425459 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Florida, Illinois, California. 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 NCT05425459 about?
NCT05425459 is a clinical study titled "RESPONDER-HF Trial". Multicenter, Prospective, Randomized, Sham Controlled, Double Blinded Clinical Trial, with; 1:1 randomization
What is the current status of trial NCT05425459?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 750 participants. The study started on 2022-11-17. Estimated completion is 2031-03.
What conditions does trial NCT05425459 study?
This clinical trial studies the following conditions: Heart Failure, Heart Failure, Diastolic. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05425459?
The interventions under investigation include: Corvia Atrial Shunt System / IASD System II (DEVICE), Intra-cardiac echocardiography (ICE), or transesophageal echocardiography (TEE) (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05425459?
This trial is sponsored by Corvia Medical, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05425459 being conducted?
This trial has 20 study locations across Arizona, California, Delaware, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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