Actively Recruiting
J-Valve Transfemoral Pivotal Study
Led by JC Medical, Inc., an affiliate of Edwards Lifesciences LLC · Updated on 2026-05-04
194
Participants Needed
40
Research Sites
380 weeks
Total Duration
On this page
Sponsors
J
JC Medical, Inc., an affiliate of Edwards Lifesciences LLC
Lead Sponsor
M
Minneapolis Heart Institute Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
J-Valve Transfemoral Pivotal Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Symptomatic with New York Heart Association (NYHA) functional class II or higher
- Severe aortic regurgitation (grade 3 or 4) confirmed by imaging
- High surgical risk as determined by a multi-disciplinary heart team
- Suitable anatomy for device insertion, delivery, and deployment
- Provided written informed consent and agree to follow-up visits
You will not qualify if you...
- Previous prosthetic aortic valve implant (bioprosthesis or mechanical)
- Aortic valve stenosis greater than moderate severity
- Severe mitral or tricuspid valve regurgitation or stenosis
- Active infection including infective endocarditis
- Cardiac masses, thrombus, or vegetation detected by imaging
- Unable to tolerate antithrombotic therapy
- Severe kidney disease (eGFR less than 30 mL/min/1.73m2) or dialysis
- Liver cirrhosis classified as Child-Pugh B or C
- Blood disorders such as leukopenia, thrombocytopenia, anemia, bleeding disorders, or unstable hypercoagulable states
- Allergies or contraindications to aspirin, heparin, bivalirudin, clopidogrel, nitinol, or contrast media
- Left ventricular ejection fraction less than 25%
- Untreated significant coronary artery disease or planned revascularization within 12 months
- Recent acute myocardial infarction or percutaneous coronary intervention within 30 days
- Recent carotid intervention within 6 weeks or carotid artery disease needing intervention
- Other surgical or interventional procedures within 30 days before or after the index procedure
- Uncontrolled atrial fibrillation
- Severe right ventricular dysfunction
- Pulmonary hypertension with systolic pressure greater than 70 mmHg or two-thirds of systemic systolic blood pressure
- Severe chronic obstructive pulmonary disease requiring chronic steroids or home oxygen
- Stroke, transient ischemic attack, or neurological symptoms due to carotid or vertebrobasilar disease within 90 days
- Cardiogenic shock or need for vasopressors or mechanical support to maintain blood pressure
- Mechanical circulatory support within 30 days
- Life expectancy under 24 months due to non-cardiac conditions
- Pregnancy or planning pregnancy before study completion
- Participation in another investigational study without primary endpoint reached
- Vulnerable populations
- Anatomical exclusions including ascending aortic diameter over 5 cm, aortic annulus perimeter under 57 mm or over 104 mm, inappropriate femoral anatomy, left ventricular end-diastolic diameter over 75 mm, congenital aortic valve disease, univentricle or conditions with high surgical risk, excessive valve prolapse, large aortic aneurysm, aorto-iliac disease needing intervention, severe vessel tortuosity, and unfavorable non-native aortic anatomy as assessed by imaging core laboratory
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 40 locations
1
HonorHealth Research & Innovation Institute
Scottsdale, Arizona, United States, 85258
Actively Recruiting
2
Scripps Memorial Hospital La Jolla
La Jolla, California, United States, 92037
Actively Recruiting
3
Cedars Sinai
Los Angeles, California, United States, 90048
Actively Recruiting
4
Stanford University Medical Center
Palo Alto, California, United States, 94394
Actively Recruiting
5
Bay Area Structural Heart at Sutter Health
San Francisco, California, United States, 94109
Actively Recruiting
6
University of California San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
7
UC Health Northern Colorado (Medical Center of the Rockies)
Loveland, Colorado, United States, 80538
Actively Recruiting
8
Washington Hospital Center DC
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
9
NCH Rooney Heart Institute
Naples, Florida, United States, 34102
Actively Recruiting
10
Emory University Atlanta
Atlanta, Georgia, United States, 30308
Actively Recruiting
11
Piedmont
Atlanta, Georgia, United States, 30309
Actively Recruiting
12
Northwestern University Chicago
Chicago, Illinois, United States, 60611
Actively Recruiting
13
Glenbrook - Endeavor Health
Glenview, Illinois, United States, 60026
Actively Recruiting
14
Ascension Via Christi
Wichita, Kansas, United States, 67214
Actively Recruiting
15
Cardiovascular Institute of the South
Houma, Louisiana, United States, 70360
Actively Recruiting
16
Massachusetts General Hospital Boston
Boston, Massachusetts, United States, 02114
Actively Recruiting
17
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
18
Henry Ford Hospital Detroit
Detroit, Michigan, United States, 48202
Actively Recruiting
19
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States, 55407
Actively Recruiting
20
CentraCare Heart and Vascular Center
Saint Cloud, Minnesota, United States, 56303
Actively Recruiting
21
Washington University - Barnes-Jewish Hospital St. Louis
St Louis, Missouri, United States, 63110
Actively Recruiting
22
University at Buffalo - Kaleida Health
Buffalo, New York, United States, 14203
Actively Recruiting
23
Columbia University Irving Medical Center/New York-Presbyterian Hospital
New York, New York, United States, 10032
Actively Recruiting
24
St. Francis Hospital
Roslyn, New York, United States, 11576
Actively Recruiting
25
Montefiore Medical Center
The Bronx, New York, United States, 10467
Actively Recruiting
26
Carolinas Health System (Atrium)
Charlotte, North Carolina, United States, 28204
Actively Recruiting
27
The Christ Hospital and The Carl & Edyth Lindner Center for Research and Education
Cincinnati, Ohio, United States, 45219
Actively Recruiting
28
Oregon Health & Science University
Portland, Oregon, United States, 97239
Actively Recruiting
29
Ascension St. Thomas West Hospital
Nashville, Tennessee, United States, 37205
Actively Recruiting
30
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
31
HCA Houston Healthcare Medical Center
Houston, Texas, United States, 77004
Actively Recruiting
32
Houston Methodist Hospital
Houston, Texas, United States, 77030
Actively Recruiting
33
The Heart Hospital - Baylor Plano
Plano, Texas, United States, 75093
Actively Recruiting
34
Swedish Heart & Vascular Research
Seattle, Washington, United States, 98122
Actively Recruiting
35
St. Paul's Hospital Vancouver
Vancouver, British Columbia, Canada, V6Z1Y6
Actively Recruiting
36
St. Michael's Hospital
Toronto, Ontario, Canada, M5B1W8
Actively Recruiting
37
Clinique Pasteur Toulouse
Toulouse, France, 31076
Actively Recruiting
38
Juntendo University Hospital
Tokyo, Bunkyo-ku, Japan, 160-8582
Actively Recruiting
39
Keio University Hospital
Tokyo, Shinjuku-Ku, Japan, 160-8582
Actively Recruiting
40
Oxford - John Radcliff Hospital
Oxford, United Kingdom, OX3 9DU
Actively Recruiting
Research Team
S
Sheri L Halverson, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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