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NCT06034028 · ClinicalTrials.gov registry record · NA
J-Valve TF Early Feasibility Study
A NA study of Aortic Valve Disease and Aortic Valve Insufficiency, sponsored by JC Medical, Inc., an affiliate of Edwards Lifesciences.
- Active
- Registry status
- NA
- Development phase
- 25
- Enrollment target
- 9
- Study locations
NCT06034028: Active NA study of Aortic Valve Disease and Aortic Valve Insufficiency, sponsored by JC Medical, Inc., an affiliate of Edwards Lifesciences.
NCT06034028 is a NA study of Aortic Valve Disease and Aortic Valve Insufficiency that is active but no longer recruiting, run by JC Medical, Inc., an affiliate of Edwards Lifesciences. The registered enrollment target is 25 participants, below the 18,615-participant average among 15 other Aortic Valve Disease trials with a reported enrollment target (100% lower). The trial reports 9 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06034028, a NA study of Aortic Valve Disease and Aortic Valve Insufficiency, is active but no longer recruiting, sponsored by JC Medical, Inc., an affiliate of Edwards Lifesciences.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 25 participants
- Enrollment target
- 9
- Study locations
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.
Primary Outcome
Freedom from death or disabling stroke Disabling stroke is evaluated using a standardized scale
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 |
What the registry record for NCT06034028 still lists
NCT06034028 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 18,615-participant average among 15 other Aortic Valve Disease trials with a reported enrollment target (100% lower).
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.
NCT06034028 lists 9 locations in 8 states (New York, Arizona, District of Columbia).
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.
What interventions are being tested in trial NCT06034028?
The interventions under investigation include: J-Valve TF System (DEVICE).
Who is sponsoring clinical trial NCT06034028?
This trial is sponsored by JC Medical, Inc., an affiliate of Edwards Lifesciences, which has 2 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT06034028's enrollment target sits among peer trials
25 14th of 15 higher than 2 of 15 other Aortic Valve Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Aortic Valve Disease 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.
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