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Assessing the J-Valve Transfemoral System for severe aortic valve regurgitation

J-Valve to Treat Aortic Regurgitation Via Transcatheter Therapy

Not applicable Interventional JC Medical, Inc., an affiliate of Edwards Lifesciences LLC · NCT06455787

This study is testing a new heart valve system to see if it can safely help people with severe aortic valve problems who are at high risk for traditional surgery.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment194 (estimated)
Ages18 Years and up
SexAll
SponsorJC Medical, Inc., an affiliate of Edwards Lifesciences LLC Industry-sponsored
Locations40 sites (Scottsdale, Arizona and 39 other locations)
Trial IDNCT06455787 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of the J-Valve Transfemoral System in patients suffering from symptomatic, severe aortic valve regurgitation and mixed aortic valve disease who are considered high-risk for traditional surgical valve replacement. It is a prospective, single-arm, multi-center study that aims to enroll up to 194 participants across various sites, primarily in the United States, with additional locations in Canada, Europe, and Japan. A sub-study using Cardiac Magnetic Resonance imaging will also assess the impact of the intervention on heart function and quality of life over a five-year follow-up period.

Who should consider this trial

Good fit: Ideal candidates include symptomatic patients with severe aortic valve regurgitation who are at high risk for open surgical aortic valve replacement.

Not a fit: Patients with mild or moderate aortic valve regurgitation or those who are not symptomatic may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could provide a less invasive treatment option for patients with severe aortic valve regurgitation, potentially improving their heart function and quality of life.

How similar studies have performed: Other studies involving transcatheter aortic valve replacement have shown promising results, indicating that this approach may be effective for similar patient populations.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Symptomatic according to New York Heart Association (NYHA) functional class (FC) II or higher
2. Severe AR, defined as follows, as assessed by Imaging Core Laboratory:

   A. Severe AR by Transthoracic Echocardiography (TTE) (grade 3 or 4)

   B. OR, if indeterminate AR, by TTE, ANY ONE of the following:

   i. Cardiac magnetic resonance imaging (CMR)-derived aortic regurgitant fraction (RF) ≥43% ii. CMR-derived RF ≥33% + left ventricular dilation (left ventricular end diastolic volume index \[LVEDVi\]) \>105 mL/m\^2 for men or LVEDVi \>96 mL/m\^2 for women) iii. CMR-derived RF ≥33% + LV ejection fraction (LVEF) ≤55% or left ventricular end systolic volume index (LVESVi) ≥43mL/m\^2; iv. Severe AR by Transesophageal Echocardiography (TEE) (grade 3 or 4)
3. High risk for surgery as judged by a multi-disciplinary heart team
4. Suitable anatomy to accommodate the insertion, delivery, and deployment of the study devices (see anatomic exclusions below)
5. Written informed consent and agreement to comply with all required post-procedure follow-up visits at investigational site.

Exclusion Criteria:

1. Previous prosthetic aortic valve (bioprosthesis or mechanical) implant
2. Aortic valve stenosis \> moderate\*
3. Severe mitral valve or tricuspid valve regurgitation\*
4. Severe mitral valve or tricuspid valve stenosis\*
5. Active infection, including infective endocarditis
6. Cardiac imaging evidence of cardiac mass, thrombus or vegetation
7. Inability to tolerate or a condition precluding treatment with antithrombotic (antiplatelet, anticoagulant) therapy
8. Renal insufficiency (eGFR \<30 mL/min/1.73m\^2) or end stage renal disease requiring chronic dialysis
9. Liver disease (cirrhosis of the liver \[Child-Pugh Class B or C\])
10. Blood dyscrasias as defined: 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)
11. Known hypersensitivity or contraindication to aspirin, heparin, bivalirudin, clopidogrel, Nitinol (Nickel, Titanium) or sensitivity to contrast media, which cannot be adequately premedicated
12. Left ventricular dysfunction with left ventricular ejection fraction (LVEF) \<25% as measured by resting echocardiogram (or by CMR, when performed)\*
13. Clinically significant untreated coronary artery disease requiring revascularization or anticipated coronary revascularization procedure within 12-months post index procedure
14. Acute myocardial infarction within 30 days prior to index procedure
15. PCI within 30 days prior to index procedure
16. Carotid intervention within 6 weeks prior to index procedure or carotid artery disease requiring intervention
17. Previous, or planned, other surgical or interventional procedures within 30 days before, during, or within 30 days after the index procedure
18. Uncontrolled atrial fibrillation
19. Severe right ventricular (RV) dysfunction\*
20. Pulmonary hypertension (systolic PA pressure \>70mmHg or systolic PA pressure ≥2/3 of systemic systolic BP)
21. Severe chronic obstructive pulmonary disease (COPD) requiring chronic oral steroids or requiring continuous home O2
22. Stroke (CVA), transient ischemic attack (TIA) or neurological signs and symptoms attributed to carotid or vertebrobasilar disease within 90 days prior to index procedure
23. Cardiogenic shock defined as systolic blood pressure \<90 mmHg in addition to signs of tissue hypoperfusion or the need for vasopressors and/or mechanical hemodynamic support to maintain systolic blood pressure ≥90mmHg
24. Patient requires mechanical circulatory support within 30 days prior to index procedure
25. Estimated life expectancy of less than 24 months due to associated non-cardiac co-morbid conditions
26. Pregnancy or intent to become pregnant prior to completion of all protocol follow-up requirements
27. Participation in another investigational study that has not reached its primary endpoint
28. Considered to be part of a vulnerable population

    * As assessed by Imaging Core Laboratory

Anatomic Exclusions:

1. Ascending Aortic diameter \>5 cm\*
2. Aortic Annulus Perimeter \<57 mm or \>104 mm\*
3. Inappropriate anatomy for femoral introduction and delivery of the study system
4. Left ventricular end-diastolic diameter (LVEDD) \>75 mm\*
5. Congenital aortic valve disease including Unicuspid, Bicuspid, or Quadricuspid aortic valve anatomy\*
6. Congenital univentricle or other condition that, in the opinion of the investigator and/or consulting physician, may constitute an unwarranted surgical risk
7. Excessive aortic valve prolapse that would preclude proper seating of the implant in the aortic annulus
8. Abdominal/thoracic aortic aneurysm ≥5.0 cm\*
9. Aorto-iliac disease requiring intervention to facilitate delivery of access sheath
10. Excessive tortuosity of delivery system pathway, defined as severe tortuosity of multiple vessels including iliofemoral, thoracoabdominal aorta, aortic arch, or LV-aortic root angle \>80⁰
11. Non-native anatomy in aortic zones 0A \& 0B (aortic valve annulus to the distal margin of the right pulmonary artery); 0C (to innominate) only if deemed unfavorable by the Study Screening Committee

    * As assessed by Imaging Core Laboratory

Where this trial is running

Scottsdale, Arizona and 39 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Aortic Valve RegurgitationAortic Valve Disease MixedJ-Valve Transfemoral SystemTranscatheter TherapyTranscatheter Aortic Valve ReplacementTAVRTransfemoral
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.