J-Valve Transfemoral Pivotal Study

Launched by JC MEDICAL, INC. · Jun 7, 2024

Keywords

ClinConnect Summary

The J-Valve Transfemoral Pivotal Study is researching a new treatment option for patients with severe aortic valve regurgitation, a condition where the heart's aortic valve does not close properly, causing blood to flow backward. This trial is specifically for individuals who have symptoms related to this condition and are considered high-risk for traditional open-heart surgery. The main goal is to evaluate the safety and effectiveness of the J-Valve Transfemoral System, which is a less invasive method to address this heart issue.

To be eligible for the trial, participants need to have significant symptoms, such as shortness of breath, and severe aortic valve regurgitation as shown through medical imaging. They must also be assessed by a heart team as being at high risk for surgery and have anatomy that allows for the J-Valve to be inserted. If someone joins the study, they can expect to receive the J-Valve treatment and will need to attend follow-up appointments to monitor their progress. It's important to note that individuals with certain health conditions, previous heart surgeries, or specific anatomical issues may not qualify for participation.

Gender

ALL

Eligibility 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. Patient is judged by a multi-disciplinary heart team to be at high risk for surgery
• • 4. Patient has suitable anatomy to accommodate the insertion, delivery, and deployment of the study valve system
• • 5. Patient or the patient's legal representative has provided written informed consent and agrees 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 including cirrhosis (Childs-Pugh Class B or C)
• • 10. Blood dyscrasias as defined: leukopenia (WBC \<3000 mm\^3), thrombocytopenia (platelet count \<50,000 cells/mm\^3), anemia (hemoglobin \<9 g/dL), history of bleeding diathesis or coagulopathy
• • 11. Known hypersensitivity or contraindication to aspirin, heparin, bivalirudin, clopidogrel, Nitinol (Nickel, Titanium, Aluminum) 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 3 months 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. Subject considered to be part of a vulnerable population
• 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 ≥4.0 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