Status:
ACTIVE_NOT_RECRUITING
J-Valve TF Early Feasibility Study
Lead Sponsor:
JC Medical, Inc., an affiliate of Edwards Lifesciences LLC
Conditions:
Aortic Valve Disease
Aortic Valve Insufficiency
Eligibility:
All Genders
Phase:
NA
Brief 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 mult...
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 al...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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);
- 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
Key Trial Info
Start Date :
October 16 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 25 2029
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT06034028
Start Date
October 16 2023
End Date
August 25 2029
Last Update
July 11 2025
Active Locations (9)
Enter a location and click search to find clinical trials sorted by distance.
1
HonorHealth
Scottsdale, Arizona, United States, 85258
2
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010
3
Advocate Christ Medical Center
Oak Lawn, Illinois, United States, 60453
4
Cardiovascular Institute of the South
Houma, Louisiana, United States, 70360