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Aortic Valve DiseaseJVTF EFSNCT06034028

J-Valve TF Early Feasibility Study

A study testing J-Valve TF System in people with Aortic Valve Disease and Aortic Valve Insufficiency, run by JC Medical, Inc., an affiliate of Edwards Lifesciences LLC at 9 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Any age
What is being tested?
J-Valve TF System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
9 sitesUnited States
Study dates
16 Oct 2023to 25 Aug 2029
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Patient has symptomatic (NYHA FC ≥ IIs) severe (≥3+) native AR (per 2020 ACC/AHA Guideline for Management of Patients with Valvular Heart Disease) diagnosed by echocardiography. Patients will be assessed according to the current American Society of Echocardiography Guidelines for Non-invasive Evaluation of Native Valve Regurgitation. Transesophageal echocardiography (TEE) or cardiac MRI (CMR) will be used in case of indeterminant AR;
  • Patient is judged by a multi-disciplinary heart team to be at high risk for surgery, based on the ACC/AHA guidelines for management of patients with valvular heart disease: STS-PROM score ≥8%, or if <8%, significant co-morbidities that are not captured by the STS-PROM score (e.g., ≥2 frailty indices, 1 to 2 major organ system compromise, the presence of certain procedure-specific factors that affect surgical mortality), based on the consensus of a multi-disciplinary heart team;
  • Patient has suitable anatomy for J-Valve implantation (see anatomic exclusions below);
  • Patient or the patient's legal representative has provided written informed consent;
  • Patient or patient's legal representative agrees to comply with all required post-procedure follow-up visits.

Who cannot join

  • Patients that are at prohibitive surgical risk (predicted risk for mortality or major morbidity at 30 days >50% with SAVR);
  • Mixed aortic valve disease, defined as coexistence of > moderate aortic valve stenosis with severe AR;
  • Known hypersensitivity or contraindication to aspirin, heparin, bivalirudin, ticlopidine, clopidogrel, Nitinol (Nickel, Titanium, Aluminum) or sensitivity to contrast media, which cannot be adequately premedicated;
  • Blood dyscrasias as defined: leukopenia (WBC <1000 mm3), thrombocytopenia (platelet count <50,000 cells/mm3), history of bleeding diathesis or coagulopathy;
  • Active infection, including infective endocarditis;
  • Liver failure (Child-C);
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  • Reduced left ventricular function with left ventricular ejection fraction (LVEF) <25% as measured by resting echocardiogram;
  • Uncontrolled atrial fibrillation (e.g., resting heart rate >120 bpm);
  • Pregnancy or intent to become pregnant prior to completion of all protocol follow-up requirements;
  • Renal insufficiency (eGFR <25) and/or end stage renal disease requiring chronic dialysis;
  • Pulmonary Hypertension (systolic pressure ≥2/3 of systemic);
  • Severe Chronic Obstructive Pulmonary Disease (COPD) = requiring steroids or requiring continuous home O2
  • Severe mitral or severe tricuspid regurgitation or stenosis;
  • Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within six weeks of treatment;
  • Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support;
  • Recent (within 6 months of treatment) cerebrovascular accident (CVA) or transient ischemic attack (TIA);
  • Active gastrointestinal (GI) bleeding that would preclude anticoagulation;
  • Untreated multivessel coronary artery disease with a Syntax score >22 and/or unprotected left main coronary artery;
  • Evidence of acute myocardial infarction within 1 month of intended procedure;
  • PCI within 30 days of intended procedure;
  • Estimated life expectancy of less than 24 months due to associated (excluding cardiac) co-morbid conditions;
  • Left Ventricular Assist Device (LVAD) dependent;
  • Participating in another study that may influence the outcome of this study;
  • Need for emergency surgery for any reason;
  • Previous aortic bioprosthesis or mechanical implant.
  • Anatomic Exclusion Criteria:
  • Ascending Aortic diameter >5 cm;
  • Aortic Annulus Perimeter <57 mm or >104 mm;
  • Access vessel minimum diameter <5.5 mm;
  • LVEDD >75 mm;
  • Bicuspid aortic valve disease;
  • Congenital univentricle or other condition that, in the opinion of the investigator and/or consulting physician, may constitute an unwarranted surgical risk.
  • Abdominal aortic aneurysm ≥ 4.0 cm;
  • 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, descending aorta, ascending aorta, aortic arch, and aortic angle >80⁰. In most cases, this exclusion will be identified and assigned following review by the multi-disciplinary Screening Committee.

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • University at Buffalo

    Buffalo, New York, 14203

  • The Christ Hospital

    Cincinnati, Ohio, 45219

  • Cardiovascular Institute of the South

    Houma, Louisiana, 70360

  • Houston Methodist Hospital

    Houston, Texas, 77030

  • Advocate Christ Medical Center

    Oak Lawn, Illinois, 60453

  • HonorHealth

    Scottsdale, Arizona, 85258

  • Swedish Medical Center Cherry Hill

    Seattle, Washington, 98122

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010

Other trials in United States

About this 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 aortic valve replacement.

Read the detailed description

The EFS is a prospective, single arm, multi-center, interventional study that will enroll up to 25 subjects in up to 15 centers in the United States and/or Canada and report the primary endpoint of all-cause death or disabling stroke at 30 days.

Being tested
J-Valve TF System
Keywords
J-Valve TF System, Transcatheter Aortic Valve Replacement, Transcatheter Aortic Valve Implantation, Transcatheter Heart Valve, Transfemoral, TAVR, TAVI, THV, VHD, Valvular Heart Disease, Valve Disease
Medical subject headings
Aortic Valve Disease, Aortic Valve Insufficiency, Heart Valve Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • J-Valve TF SystemDevice

    The J-Valve TF System is a transcatheter aortic valve replacement system that consists of the J-Valve TF Bioprosthesis, J-Valve TF Delivery Device, and Loading Accessories.

Study groups in NCT06034028
Study groupRoleWhat they receive
J-Valve TF SystemExperimentalNot described
Receives: Device: J-Valve TF System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of patients that do not experience death or disabling stroke

    Freedom from death or disabling stroke Disabling stroke is evaluated using a standardized scale

    Measured: 30 days after the valve procedure

Secondary outcomes (9)

  1. Number of patients and procedures achieving technical success

    Procedures achieving the following:

    • Patient is alive;
    • There was successful access, delivery of the valve, and retrieval of the delivery device;
    • There was correct positioning of a single prosthetic heart valve into the proper anatomical location;
    • There was no need for surgery or intervention due to the device, except permanent pacemaker placement, or for a major complication that it vascular, access-related, or cardiac in nature

    Measured: At point patient exits the procedure room

  2. Number of patients and procedures achieving device success

    • There was successful access, delivery of the valve, and retrieval of the delivery device;
    • There was correct positioning of a single prosthetic heart valve into the proper anatomical location;
    • There was no need for surgery or intervention due to the device, except permanent pacemaker placement, or for a major complication that it vascular, access-related, or cardiac in nature;
    • Patient is alive;
    • There was not surgery or intervention due to the device, except permanent pacemaker placement, or for a major complication that it vascular, access-related, or cardiac in nature;
    • The valve was performing as intended, measured by echocardiography

    Measured: 30 days after the valve procedure

  3. Number of patients with a safety-related event outcome

    Freedom from:

    • All-cause death;
    • All stroke;
    • Valve Academic Research Consortium (VARC)-3 type 2-4 bleeding;
    • Major vascular, access-related, or cardiac structural complication;
    • Acute kidney injury stage 3 or 4;
    • Moderate or severe aortic regurgitation;
    • New permanent pacemaker due to procedure related conduction abnormalities;
    • Surgery or intervention related to the device.

    Measured: 30 days after the valve procedure

  4. Number of patients experiencing success

    No re-hospitalization or re-interventions for the underlying condition and improvement, from baseline, in symptoms, which are measured using the Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary (OS) score.

    Success in an increase from baseline of 10 or more points on the KCCQ-OS score.

    Measured: 1 year after the valve procedure

  5. Number of patients meeting clinical efficacy outcome at 2 years

    • Freedom-from all-cause death;
    • Freedom from all stroke;
    • Freedom from hospitalization for procedure- or valve-related causes;
    • Freedom from KCCQ-OS score < 45 or decline from baseline of >10 points;
    • Good Outcome: Alive with change in KCCQ-OS score >=10 points;
    • Excellent outcome: Alive with change in KCCQ-OS score >=20 points.

    Measured: 2 years after the valve procedure

  6. Number of patients meeting clinical efficacy outcome at 3 years

    • Freedom-from all-cause death;
    • Freedom from all stroke;
    • Freedom from hospitalization for procedure- or valve-related causes;
    • Freedom from KCCQ-OS score < 45 or decline from baseline of >10 points;
    • Good Outcome: Alive with change in KCCQ-OS score >=10 points;
    • Excellent outcome: Alive with change in KCCQ-OS score >=20 points.

    Measured: 3 years after the valve procedure

  7. Number of patients meeting clinical efficacy outcome at 4 years

    • Freedom-from all-cause death;
    • Freedom from all stroke;
    • Freedom from hospitalization for procedure- or valve-related causes;
    • Freedom from KCCQ-OS score < 45 or decline from baseline of >10 points;
    • Good Outcome: Alive with change in KCCQ-OS score >=10 points;
    • Excellent outcome: Alive with change in KCCQ-OS score >=20 points.

    Measured: 4 years after the valve procedure

  8. Number of patients meeting clinical efficacy outcome at 5 years

    • Freedom-from all-cause death;
    • Freedom from all stroke;
    • Freedom from hospitalization for procedure- or valve-related causes;
    • Freedom from KCCQ-OS score < 45 or decline from baseline of >10 points;
    • Good Outcome: Alive with change in KCCQ-OS score >=10 points;
    • Excellent outcome: Alive with change in KCCQ-OS score >=20 points.

    Measured: 5 years after the valve procedure

  9. Number of patients achieving long-term clinical efficacy for valve function

    Freedom from:

    • Bioprosthetic valve failure (defined as Valve-related mortality or aortic valve re-operation/re-intervention or Stage 3 hemodynamic valve deterioration);
    • Stroke or peripheral embolism (presumably valve- related, after ruling out other non-valve etiologies);
    • VARC-3 Type 2-4 bleeding secondary to or exacerbated by antiplatelet
    • or anticoagulant agents, used specifically for valve- related concerns.

    Measured: 5 years after the valve procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2023
  2. Study start16 Oct 2023
  3. Primary completion17 Jul 2024
  4. Study completion25 Aug 2029 (estimated)

Resources

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
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06034028
Sponsor's protocol ID
JCM-001
Acronym
JVTF EFS
Status last verified
Jul 2025
First submitted
28 Aug 2023
Last updated
11 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Writing Committee Members; Otto CM, Nishimura RA, Bonow RO, Carabello BA, Erwin JP 3rd, Gentile F, Jneid H, Krieger EV, Mack M, McLeod C, O'Gara PT, Rigolin VH, Sundt TM 3rd, Thompson A, Toly C. 2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 2021 Feb 2;77(4):e25-e197. doi: 10.1016/j.jacc.2020.11.018. Epub 2020 Dec 17. No abstract available.

    PubMed 33342586

Questions about this trial

What is this clinical trial studying?

A study testing J-Valve TF System in people with Aortic Valve Disease and Aortic Valve Insufficiency, run by JC Medical, Inc., an affiliate of Edwards Lifesciences LLC at 9 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 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 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?

Number of patients that do not experience death or disabling stroke (time frame: 30 days after the valve procedure). 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 NCT06034028, 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 11 Jul 2025.

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