Aortic Valve RegurgitationNCT07363473
JOURNEY LVAD: JOURNEY Left Ventricular Assist Device
A study testing J-Valve Transfemoral System in people with Aortic Valve Regurgitation and Aortic Valve Disease Mixed, run by JC Medical, Inc., an affiliate of Edwards Lifesciences LLC at 2 sites in United States.
Trial summary
The objective of this study is to assess the safety and effectiveness of the J-Valve Transfemoral Transcatheter Heart Valve System in patients on left ventricular assist device (LVAD) support with significant native aortic valve regurgitation (AR). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Regurgitation, Aortic Valve Disease Mixed, Aortic Insufficiency
- What is being tested?
- J-Valve Transfemoral System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Sep 2026to Apr 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult with durable left ventricular assist device (LVAD) support and clinically significant AR (grade 4 or higher as assessed by core lab using TTE and adjunct TEE, if necessary) leading to LVAD dysfunction
- Symptomatic according to New York Heart Association (NYHA) functional class II or higher
- High risk for surgery as judged by a multi-disciplinary heart team
- Suitable anatomy to accommodate the insertion, delivery, and deployment of the study devices (see anatomic exclusions below)
- Written informed consent and agreement to comply with all required follow-up visits at investigational site
Who cannot join
- Prior aortic valve replacement or repair
- Aortic valve stenosis > moderate as assessed by core lab
- Severe mitral valve or tricuspid valve regurgitation as assessed by core lab
- Severe mitral valve or tricuspid valve stenosis as assessed by core lab
- Active infection requiring current antibiotic therapy, including infective endocarditis
- Cardiac imaging evidence of cardiac mass, thrombus or vegetation
Show all 35Show fewer
- Inability to tolerate or a condition precluding treatment with antithrombotic (antiplatelet, anticoagulant) therapy
- Renal insufficiency (eGFR <25 mL/min/1.73m2) or end stage renal disease requiring chronic dialysis
- Cirrhosis (Child-Pugh Class B or C)
- Leukopenia (WBC <3000 cells/mcL), thrombocytopenia (platelet count <50,000 cells/mcL), anemia (hemoglobin <9 g/dL), history of bleeding diathesis, coagulopathy, or hypercoagulable state (unless therapeutically stable)
- Known hypersensitivity or contraindication to aspirin, heparin, bivalirudin, clopidogrel, Nitinol (Nickel, Titanium) or sensitivity to contrast media which cannot be adequately premedicated
- Clinically significant untreated coronary artery disease requiring revascularization or anticipated coronary revascularization procedure within 12 months post-index procedure
- Acute myocardial infarction within 30 days prior to index procedure
- PCI within 30 days prior to index procedure
- Carotid intervention within 6 weeks prior to index procedure or carotid artery disease requiring intervention
- Previous, or planned, other surgical or interventional procedures within 30 days before, during, or within 30 days after the index procedure
- Uncontrolled atrial fibrillation
- Severe right ventricular (RV) dysfunction as assessed by core lab or chronic inotrope support (>30 days)
- Severe pulmonary hypertension (systolic pulmonary artery pressure >80 mmHg measured by right heart catheterization)
- Severe chronic obstructive pulmonary disease (COPD) requiring chronic oral steroids or requiring continuous home oxygen
- Stroke (cerebrovascular accident, CVA), transient ischemic attack (TIA) or neurological signs and symptoms attributed to carotid or vertebrobasilar disease within 90 days prior to index procedure
- Estimated life expectancy of less than 12 months
- Pregnancy or intent to become pregnant prior to completion of all protocol follow-up requirements
- Participation in another investigational study that has not reached its primary endpoint
- Considered to be part of a vulnerable population
- Anatomic Exclusions:
- Ascending aortic diameter ≥5.5 cm as assessed by core lab
- Aortic annulus perimeter <57 mm or >104 mm as assessed by core lab
- Inappropriate anatomy for femoral introduction and delivery of the study system
- Congenital aortic valve disease including unicuspid, bicuspid, or quadricuspid aortic valve anatomy as assessed by core lab
- Congenital univentricle or other condition that, in the opinion of the investigator and/or consulting physician, may constitute an unwarranted surgical risk
- Excessive aortic valve prolapse or leaflet deterioration that would preclude proper seating of the implant in the aortic annulus
- Abdominal/thoracic aortic aneurysm ≥5.0 cm as assessed by core lab
- Aorto-iliac disease requiring intervention to facilitate delivery of access sheath
- Excessive tortuosity of delivery system pathway, defined as severe tortuosity of multiple vessels including iliofemoral, thoracoabdominal aorta, aortic arch, and/or LV-aortic root angle >80°
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Ascension St. Thomas West Hospital
Nashville, Tennessee, 37205
About this study
Official title: Transcatheter Therapy to Treat Aortic Regurgitation in the Presence of a Left Ventricular Assist Device
The objective of this study is to assess the safety and effectiveness of the J-Valve Transfemoral Transcatheter Heart Valve System in patients on left ventricular assist device (LVAD) support with significant native aortic valve regurgitation (AR).
- Being tested
- J-Valve Transfemoral System
- Keywords
- J-Valve Transfemoral System, Transcatheter Therapy, Transcatheter Aortic Valve Replacement, TAVR, Transfemoral, Left Ventricular Assist Device, LVAD
- Medical subject headings
- Aortic Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
J-Valve Transfemoral SystemDevice
Treatment includes using the J-Valve Transfemoral (TF) System, a transcatheter aortic valve replacement system that consists of the J-Valve TF Bioprosthesis and the J-Valve TF Delivery Device and Loading Accessories, during transcatheter aortic valve replacement (TAVR). The Edwards 16Fr eSheath+ Introducer Set may be used for the introduction and removal of the J-Valve TF System.
| Study group | Role | What they receive |
|---|---|---|
| J-Valve Transfemoral System | Experimental | Not described Receives: Device: J-Valve Transfemoral System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Effectiveness Endpoint
Freedom from moderate or severe total aortic regurgitation
Measured: 30 days
Primary Safety Endpoint
Freedom from all-cause mortality
Measured: 30 days
Secondary outcomes (3)
Valve embolization
Valve embolization
Measured: During index procedure
Need for second bioprosthetic valve
Need for second bioprosthetic valve
Measured: During index procedure
Change in cardiovascular-specific health status
Change in cardiovascular-specific health status as measured by the Kansas City Cardiomyopathy Questionnaire overall summary (KCCQ-OS) score
Measured: 30 days compared with baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start22 Sep 2026
- Primary completionMar 2028 (estimated)
- Study completionApr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aortic Valve RegurgitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The investigation is a prospective, single arm, multi-center, interventional pivotal study
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- JC Medical, Inc., an affiliate of Edwards Lifesciences LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard Cheng, MD, Study chair, University of California, Los AngelesAndrew Morse, MD, Principal investigator, Ascension St. ThomasUlrich Jorde, MD, Principal investigator, Montefiore Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07363473
- Sponsor's protocol ID
- JCM-003
- Status last verified
- Feb 2026
- First submitted
- 22 Jan 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Garcia S, Dowling R, Chung E, Egnaczyk GF, Stewart-Dehner TL, Answini GA, Paige D, Kereiakes DJ. J-Valve Transcatheter Treatment of Native Valve Aortic Regurgitation Associated With a Left Ventricular Assist Device. J Soc Cardiovasc Angiogr Interv. 2023 Jun 9;2(4):101044. doi: 10.1016/j.jscai.2023.101044. eCollection 2023 Jul-Aug. No abstract available.
PubMed 39131634
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcatheter Therapy to Treat Aortic Regurgitation in the Presence of a Left Ventricular Assist Device
- ClinicalTrials.gov ID
- NCT07363473
- Acronym / sponsor ID
- JCM-003
- Keywords
- J-Valve Transfemoral System, Transcatheter Therapy, Transcatheter Aortic Valve Replacement, TAVR, Transfemoral, Left Ventricular Assist Device, LVAD
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- JC Medical, Inc., an affiliate of Edwards Lifesciences LLCIndustry (pharma, biotech, devices)
- Study start
- 22 Sep 2026 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Apr 2030 (estimated)
- First posted
- 23 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to assess the safety and effectiveness of the J-Valve Transfemoral Transcatheter Heart Valve System in patients on left ventricular assist device (LVAD) support with significant native aortic valve regurgitation (AR).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The investigation is a prospective, single arm, multi-center, interventional pivotal study
| Arm | Type | Receives |
|---|---|---|
| J-Valve Transfemoral System | Experimental | Device: J-Valve Transfemoral System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult with durable left ventricular assist device (LVAD) support and clinically significant AR (grade 4 or higher as assessed by core lab using TTE and adjunct TEE, if necessary) leading to LVAD dysfunction
- Symptomatic according to New York Heart Association (NYHA) functional class II or higher
- High risk for surgery as judged by a multi-disciplinary heart team
- Suitable anatomy to accommodate the insertion, delivery, and deployment of the study devices (see anatomic exclusions below)
- Written informed consent and agreement to comply with all required follow-up visits at investigational site
Key exclusion criteria (35 listed)
- Prior aortic valve replacement or repair
- Aortic valve stenosis > moderate as assessed by core lab
- Severe mitral valve or tricuspid valve regurgitation as assessed by core lab
- Severe mitral valve or tricuspid valve stenosis as assessed by core lab
- Active infection requiring current antibiotic therapy, including infective endocarditis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| J-Valve Transfemoral SystemTreatment includes using the J-Valve Transfemoral (TF) System, a transcatheter aortic valve replacement system that consists of the J-Valve TF Bioprosthesis and the J-Valve TF Delivery Device and Loading Accessories, during transcatheter aortic valve replacement (TAVR). The Edwards 16Fr eSheath+ Introducer Set may be used for the introduction and removal of the J-Valve TF System. | Device | J-Valve Transfemoral System |
Primary outcome
Primary Effectiveness Endpoint
Time frame: 30 days
Freedom from moderate or severe total aortic regurgitation
Primary Safety Endpoint
Time frame: 30 days
Freedom from all-cause mortality
3 secondary outcomes
Valve embolization
Time frame: During index procedure
Need for second bioprosthetic valve
Time frame: During index procedure
Change in cardiovascular-specific health status
Time frame: 30 days compared with baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Background: PubMed 39131634Garcia S, Dowling R, Chung E, Egnaczyk GF, Stewart-Dehner TL, Answini GA, Paige D, Kereiakes DJ. J-Valve Transcatheter Treatment of Native Valve Aortic Regurgitation Associated With a Left Ventricular Assist Device. J Soc Cardiovasc Angiogr Interv. 2023 Jun 9;2(4):101044. doi: 10.1016/j.jscai.2023.101044. eCollection 2023 Jul-Aug. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Cheng, MD study chair
University of California, Los Angeles
Andrew Morse, MD principal investigator
Ascension St. Thomas
Ulrich Jorde, MD principal investigator
Montefiore Health System
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing J-Valve Transfemoral System in people with Aortic Valve Regurgitation and Aortic Valve Disease Mixed, run by JC Medical, Inc., an affiliate of Edwards Lifesciences LLC at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Effectiveness Endpoint (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07363473, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.