J-Valve to Treat Aortic Regurgitation via Transcatheter Therapy

What is the Purpose of this Study?

The purpose of this study is to learn about the safety and performance of an experimental device called the J-Valve TF System. The device is designed to treat severe aortic regurgitation, (AR). AR occurs when the aortic valve does not close properly, which causes blood to leak back into the heart. People with severe symptomatic AR who are considered at high risk to open surgical aortic valve replacement will be suitable for the study. When compared to open chest surgery, the study procedure is less invasive, as it is performed through catheters in the Cath Lab. Patients enrolled and participating in the study will be followed by clinic visits up to 5 years.

Eligibility

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)

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

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Where can I participate?

Beverly

More about this Clinical Trial

What is the full name of this clinical trial?

J-Valve to Treat Aortic Regurgitation via Transcatheter Therapy

Study Details

Disease Type/Condition

Other

Principal Investigator

Makkar, Rajendra

Age Group

Adult

Phase

III

IRB Number

STUDY00004030

ClinicalTrials.gov ID

NCT06455787

Key Eligibility

ClinicalTrials.gov

How do I learn more about this study?

clinicaltrials@cshs.org