Actively Recruiting
J-Valve to Treat Aortic Regurgitation Via Transcatheter Therapy
Led by JC Medical, Inc., an affiliate of Edwards Lifesciences LLC · Updated on 2026-05-04
194
Participants Needed
40
Research Sites
208 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
Researchers are evaluating the safety and effectiveness of the J-Valve Transfemoral (TF) System in adults with symptomatic, severe native aortic valve regurgitation (AR) or AR-dominant mixed aortic valve disease. The study focuses on patients considered high risk for traditional open surgical aortic valve replacement. A sub-study using Cardiac Magnetic Resonance (CMR) imaging will explore how treating AR affects heart muscle remodeling, clinical outcomes, quality of life, and differences between genders. This is a prospective, single-arm, multi-center interventional study enrolling up to 194 participants across up to 35 sites in the United States, Canada, Europe, and Japan. Treatment involves using the J-Valve TF System, a transcatheter aortic valve replacement device delivered via a catheter through the femoral artery. Up to 40 initial roll-in subjects may be treated to gain experience with the device. Participants will be followed for five years after the procedure. Participants will undergo detailed assessments including imaging tests like transthoracic and transesophageal echocardiography, and CMR scans for the sub-study. Researchers will track outcomes such as survival at one year, early safety events within 30 days, and improvements in heart function and health status over one year. Follow-up visits and evaluations will continue throughout the five-year post-procedure period to monitor long-term safety and effectiveness.
CONDITIONS
Brief Title
J-Valve Transfemoral Pivotal Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Symptomatic with New York Heart Association functional class II or higher
- Severe aortic valve regurgitation (grade 3 or 4) confirmed by transthoracic or transesophageal echocardiography, or cardiac magnetic resonance imaging criteria
- Considered high risk for open surgical aortic valve replacement by a multi-disciplinary heart team
- Suitable heart anatomy to allow device insertion and deployment
- Ability to provide written informed consent and comply with follow-up visits
You will not qualify if you...
- Previous prosthetic aortic valve implant
- Moderate or greater aortic valve stenosis
- Severe mitral or tricuspid valve regurgitation or stenosis
- Active infection including infective endocarditis
- Cardiac masses, thrombus, or vegetation detected by imaging
- Inability to tolerate antithrombotic therapy
- Severe kidney failure or dialysis dependency
- Liver cirrhosis (Child-Pugh Class B or C)
- Blood disorders such as low white cells, platelets, or hemoglobin, or bleeding disorders
- Allergies to device materials or contrast agents
- Left ventricular ejection fraction below 25%
- Untreated significant coronary artery disease or recent heart interventions
- Recent heart attack or carotid interventions
- Planned or recent other surgeries or interventions
- Uncontrolled atrial fibrillation
- Severe right ventricular dysfunction
- High pulmonary hypertension
- Severe chronic obstructive pulmonary disease requiring steroids or oxygen
- Recent stroke or transient ischemic attack
- Cardiogenic shock or need for mechanical support
- Life expectancy under 24 months due to other conditions
- Pregnancy or planning pregnancy during study
- Participation in another investigational study without completed primary endpoint
- Considered vulnerable population
- Anatomical exclusions including large ascending aorta, inappropriate valve or vessel sizes, congenital valve abnormalities, aneurysms, vessel disease requiring intervention, and extreme vessel tortuosity as assessed by imaging core laboratory
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure
Participants receive the J-Valve Transfemoral (TF) System treatment via transcatheter aortic valve replacement.
1 procedure visit (in-person)
Duration - 5 years post-procedure
Participants are followed for safety and health status assessments after the procedure, including monitoring for all-cause mortality and cardiovascular improvements.
Regular follow-up visits during 5 years
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
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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