Aortic Insufficiency, Aortic Valve Disease Mixed, Aortic Valve Regurgitation
Conditions
Keywords
J-Valve Transfemoral System, Transcatheter Therapy, Transcatheter Aortic Valve Replacement, TAVR, Transfemoral, Left Ventricular Assist Device, LVAD
Brief summary
The objective of this study is to assess the safety and effectiveness of the J-Valve Transfemoral Transcatheter Heart Valve System in patients on left ventricular assist device (LVAD) support with significant native aortic valve regurgitation (AR).
Interventions
DEVICEJ-Valve Transfemoral System
Treatment includes using the J-Valve Transfemoral (TF) System, a transcatheter aortic valve replacement system that consists of the J-Valve TF Bioprosthesis and the J-Valve TF Delivery Device and Loading Accessories, during transcatheter aortic valve replacement (TAVR). The Edwards 16Fr eSheath+ Introducer Set may be used for the introduction and removal of the J-Valve TF System.
Sponsors
JC Medical, Inc., an affiliate of Edwards Lifesciences LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The investigation is a prospective, single arm, multi-center, interventional pivotal study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adult with durable left ventricular assist device (LVAD) support and clinically significant AR (grade 4 or higher as assessed by core lab using TTE and adjunct TEE, if necessary) leading to LVAD dysfunction 2. Symptomatic according to New York Heart Association (NYHA) functional class II or higher 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 follow-up visits at investigational site
Exclusion criteria
1. Prior aortic valve replacement or repair 2. Aortic valve stenosis \> moderate as assessed by core lab 3. Severe mitral valve or tricuspid valve regurgitation as assessed by core lab 4. Severe mitral valve or tricuspid valve stenosis as assessed by core lab 5. Active infection requiring current antibiotic therapy, 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 \<25 mL/min/1.73m2) or end stage renal disease requiring chronic dialysis 9. Cirrhosis (Child-Pugh Class B or C) 10. 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. Clinically significant untreated coronary artery disease requiring revascularization or anticipated coronary revascularization procedure within 12 months post-index procedure 13. Acute myocardial infarction within 30 days prior to index procedure 14. PCI within 30 days prior to index procedure 15. Carotid intervention within 6 weeks prior to index procedure or carotid artery disease requiring intervention 16. Previous, or planned, other surgical or interventional procedures within 30 days before, during, or within 30 days after the index procedure 17. Uncontrolled atrial fibrillation 18. Severe right ventricular (RV) dysfunction or chronic inotrope support (\>30 days) 19. Severe pulmonary hypertension (systolic pulmonary artery pressure \>80 mmHg measured by right heart catheterization) 20. Severe chronic obstructive pulmonary disease (COPD) requiring chronic oral steroids or requiring continuous home oxygen 21. Stroke (cerebrovascular accident, CVA), transient ischemic attack (TIA) or neurological signs and symptoms attributed to carotid or vertebrobasilar disease within 90 days prior to index procedure 22. Estimated life expectancy of less than 12 months 23. Pregnancy or intent to become pregnant prior to completion of all protocol follow-up requirements 24. Participation in another investigational study that has not reached its primary endpoint 25. Considered to be part of a vulnerable population Anatomic Exclusions: 1. Ascending aortic diameter ≥5.5 cm as assessed by core lab 2. Aortic annulus perimeter \<57 mm or \>104 mm as assessed by core lab 3. Inappropriate anatomy for femoral introduction and delivery of the study system 4. Congenital aortic valve disease including unicuspid, bicuspid, or quadricuspid aortic valve anatomy as assessed by core lab 5. Congenital univentricle or other condition that, in the opinion of the investigator and/or consulting physician, may constitute an unwarranted surgical risk 6. Excessive aortic valve prolapse or leaflet deterioration that would preclude proper seating of the implant in the aortic annulus 7. Abdominal/thoracic aortic aneurysm ≥5.0 cm as assessed by core lab 8. Aorto-iliac disease requiring intervention to facilitate delivery of access sheath 9. Excessive tortuosity of delivery system pathway, defined as severe tortuosity of multiple vessels including iliofemoral, thoracoabdominal aorta, aortic arch, and/or LV-aortic root angle \>80°
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Effectiveness Endpoint | 30 days | Freedom from moderate or severe total aortic regurgitation |
| Primary Safety Endpoint | 30 days | Freedom from all-cause mortality |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Valve embolization | During index procedure | Valve embolization |
| Need for second bioprosthetic valve | During index procedure | Need for second bioprosthetic valve |
| Change in cardiovascular-specific health status | 30 days compared with baseline | Change in cardiovascular-specific health status as measured by the Kansas City Cardiomyopathy Questionnaire overall summary (KCCQ-OS) score |
Contacts
CONTACTSheri L Halverson, MPH
STUDY_CHAIRRichard Cheng, MD
University of California, Los Angeles
PRINCIPAL_INVESTIGATORAndrew Morse, MD
Ascension St. Thomas
PRINCIPAL_INVESTIGATORUlrich Jorde, MD
Montefiore Health System
Outcome results
None listed