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NCT06455787 · ClinicalTrials.gov registry record · NA
J-Valve Transfemoral Pivotal Study
A NA study of Aortic Valve Regurgitation and Aortic Valve Disease Mixed, sponsored by JC Medical, Inc., an affiliate of Edwards Lifesciences.
- Recruiting
- Registry status
- NA
- Development phase
- 194
- Enrollment target
- 20
- Study locations
NCT06455787 is a NA study of Aortic Valve Regurgitation and Aortic Valve Disease Mixed that is actively recruiting participants, run by JC Medical, Inc., an affiliate of Edwards Lifesciences. The registered enrollment target is 194 participants. The trial reports 20 study locations across 12 states.
The verdict
NCT06455787, a NA study of Aortic Valve Regurgitation and Aortic Valve Disease Mixed, is actively recruiting participants, sponsored by JC Medical, Inc., an affiliate of Edwards Lifesciences.
- RECRUITING
- Registry status
- NA
- Development phase
- 194 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary objective of this study is to assess the safety and efficacy of the J-Valve Transfemoral (TF) System in patients with symptomatic, severe (grade 3 or 4), native aortic valve regurgitation (AR) and AR-dominant mixed aortic valve disease, who are judged by a multi-disciplinary heart team to be at high risk for open surgical aortic valve replacement (SAVR). A Cardiac Magnetic Resonance (CMR) sub-study will examine if intervention for AR translates to improved ventricular remodeling, the impact of LV remodeling on clinical outcomes and quality of life, as well as volumetric and myocardial differences between genders.
Conditions Studied
Interventions
- DEVICE J-Valve Transfemoral (TF) System
Study Locations (20)
California
- Cedars Sinai - Los Angeles
- Stanford University Medical Center - Palo Alto
- Bay Area Structural Heart at Sutter Health - San Francisco
- University of California San Francisco - San Francisco
Georgia
- Emory University Atlanta - Atlanta
- Piedmont - Atlanta
Illinois
- Northwestern University Chicago - Chicago
- Glenbrook - Endeavor Health - Glenview
Louisiana
- Cardiovascular Institute of the South - Houma
- Terrebonne General (CIS) - Houma
Massachusetts
- Massachusetts General Hospital Boston - Boston
- Brigham and Women's Hospital - Boston
Minnesota
- Minneapolis Heart Institute Foundation - Minneapolis
- CentraCare Heart and Vascular Center - Saint Cloud
Arizona
- HonorHealth Research & Innovation Institute - Scottsdale
Colorado
- UC Health Northern Colorado (Medical Center of the Rockies) - Loveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 194 participants |
| Start Date | 2024-10-17 |
| Est. Completion | 2032-02 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06455787
The ClinicalTrials.gov registry entry for NCT06455787 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 194 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 2 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Aortic Valve Regurgitation appearing as the primary indexed condition, and to 1 intervention - of which J-Valve Transfemoral (TF) System is the first listed.
NCT06455787 reports 20 study locations spanning 12 distinct geographic areas - top geographies include California, Georgia, Illinois.
Frequently Asked Questions
What is clinical trial NCT06455787 about?
NCT06455787 is a clinical study titled "J-Valve Transfemoral Pivotal Study". The primary objective of this study is to assess the safety and efficacy of the J-Valve Transfemoral (TF) System in patients with symptomatic, severe (grade 3 or 4), native aortic valve regurgitation (AR) and AR-dominant mixed aortic valve disease, who are judged by a multi-disciplinary heart team t...
What is the current status of trial NCT06455787?
This trial is currently recruiting. It is a NA study. The enrollment target is 194 participants. The study started on 2024-10-17. Estimated completion is 2032-02.
What conditions does trial NCT06455787 study?
This clinical trial studies the following conditions: Aortic Valve Regurgitation, Aortic Valve Disease Mixed.
What interventions are being tested in trial NCT06455787?
The interventions under investigation include: J-Valve Transfemoral (TF) System (DEVICE).
Who is sponsoring clinical trial NCT06455787?
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 NCT06455787 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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