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J-Valve TF Early Feasibility Study
NCT06034028 · View on ClinicalTrials.gov ↗
Study Summary
The main objective of this study is to assess the preliminary safety and effectiveness of the J-Valve TF System in patients with symptomatic severe native aortic regurgitation who are judged by a multi-disciplinary heart team to be eligible for the device and to be at high risk for open surgical aortic valve replacement.
Conditions Studied
Interventions
- DEVICE J-Valve TF System
Study Locations (9)
New York
- University at Buffalo — Buffalo
- Montefiore Medical Center — The Bronx
Arizona
- HonorHealth — Scottsdale
District of Columbia
- MedStar Washington Hospital Center — Washington D.C.
Illinois
- Advocate Christ Medical Center — Oak Lawn
Louisiana
- Cardiovascular Institute of the South — Houma
Ohio
- The Christ Hospital — Cincinnati
Texas
- Houston Methodist Hospital — Houston
Washington
- Swedish Medical Center Cherry Hill — Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2023-10-16 |
| Est. Completion | 2029-08-25 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06034028
The ClinicalTrials.gov registry entry for NCT06034028 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 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is JC Medical, Inc., an affiliate of Edwards Lifesciences, which has 30 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Aortic Valve Disease appearing as the primary indexed condition, and to 1 intervention — of which J-Valve TF System 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: NCT06034028 reports 9 study locations spanning 8 distinct geographic areas — top geographies include New York, Arizona, District of Columbia. 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 NCT06034028 about?
NCT06034028 is a clinical study titled "J-Valve TF Early Feasibility Study". The main objective of this study is to assess the preliminary safety and effectiveness of the J-Valve TF System in patients with symptomatic severe native aortic regurgitation who are judged by a multi-disciplinary heart team to be eligible for the device and to be at high risk for open surgical aor...
What is the current status of trial NCT06034028?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 25 participants. The study started on 2023-10-16. Estimated completion is 2029-08-25.
What conditions does trial NCT06034028 study?
This clinical trial studies the following conditions: Aortic Valve Disease, Aortic Valve Insufficiency, Aortic Regurgitation. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06034028?
The interventions under investigation include: J-Valve TF System (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06034028?
This trial is sponsored by JC Medical, Inc., an affiliate of Edwards Lifesciences, which has 30 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06034028 being conducted?
This trial has 9 study locations across Arizona, District of Columbia, Illinois, Louisiana, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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