Aortic Insufficiency, Aortic Regurgitation, Aortic Valve Disease, Aortic Valve Insufficiency, Left Ventricular Dysfunction
Conditions
Brief summary
To evaluate the safety and effectiveness of the JenaValve Trilogy™ Heart Valve System for transcatheter aortic valve replacement (TAVR) in subjects with continuous flow left ventricular assist devices (cfLVAD) and clinically significant aortic regurgitation (AR) who are indicated for TAVR
Interventions
TAVR with JenaValve Trilogy Heart Valve System
Sponsors
JenaValve Technology, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subjects \>=18 years of age with continuous flow LVAD (cfLVAD) with clinically significant AR1 leading to cfLVAD dysfunction using cfLVAD ASE guidelines that utilize contemporary management strategies for measurement of AR in patients with cfLVAD2,3: • AR is graded from 0 to 6 (0 = none; 1 = trace; 2 = mild; 3 = mild-to-moderate; 4 = moderate; 5 = moderate-to-severe; 6 = severe). Considering that AR during continuous flow LVAD (cfLVAD) support is generally both systolic and diastolic, AR is deemed significant if graded ≥ 3.1 2. Patient with NYHA functional class III/IV 3. Patient with high risk for SAVR as documented by Heart Team. 4. Patient has suitable anatomy to accommodate the insertion and delivery of the JenaValve Trilogy™ Heart Valve System 5. Patient or the patient's legal representative has provided written informed consent 6. Patient or the patient's legal representative agrees to comply with all required post-procedure follow-up visits
Exclusion criteria
1. Congenital uni- or bicuspid (Sievers 0) aortic valve morphology 2. Previous prosthetic aortic valve (bioprosthesis or mechanical) implant 3. Mitral regurgitation \&gt; moderate 4. Clinically significant coronary artery disease (CAD) requiring revascularization within 30 days prior to index procedure, or planned CAD revascularization procedure within 12 months after index procedure 5. Echocardiographic or CT evidence of left ventricular or aortic valve thrombus 6. Ongoing sepsis or active infective endocarditis with ongoing antibiotic (including suppressive) therapy or positive blood cultures within 6 weeks 7. Hypertrophic cardiomyopathy with or without obstruction 8. Severe pulmonary hypertension (systolic PA pressure \&gt;80 mmHg) 9. Decompensated right heart failure as assessed clinically and, if available, by baseline right heart catheterization hemodynamics (e.g., right atrial pressure \> pulmonary capillary wedge pressure and cardiac index \< 2.5 L/min/m2 10. Severe RV dysfunction as assessed clinically and by echocardiography 11. Aortic annular diameter of \<21.0 mm or \> 28.6 mm (assessed by Multi-detector CT measurement) 12. Aortic annulus angulation \> 70° (assessed by Multi-detector CT measurement) 13. Straight length of ascending aorta of \< 55 mm 14. Significant disease of ascending aorta, including ascending aortic aneurysm (defined as maximal luminal diameter of 50 mm or greater) or atheroma (including if thick \[\>5 mm\], protruding or ulcerated) 15. Myocardial infarction \< 30 days prior to index procedure 16. Cerebrovascular event (TIA, stroke) \< 180 days prior to index procedure 17. Blood dyscrasias as defined: leukopenia (WBC \< 3000/mm³), or thrombocytopenia (platelets \< 90,000/μl) or anemia (Men: Hgb \< 8.1 g/dl; Women: Hgb \< 7.4 g/dl) 18. Active peptic ulcer or upper gastrointestinal bleeding \< 90 days prior to index procedure 19. Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine or clopidogrel, nitinol, tantalum or allergy to contrast agents that cannot be premedicated 20. Subject unable to undergo pre-procedure transesophageal echocardiography or Multi-Detector CT (MDCT) scan for aortic annular sizing 21. Patient is enrolled in another investigational medical device or drug study which has not completed the required primary endpoint follow-up. (Note: Patients involved in a long-term surveillance phase of another study are eligible for enrollment in this registry)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device Success | 30 days | Freedom from unsuccessful delivery of the device, and retrieval of the delivery system |
| Device Positioning | 30 days | Freedom from incorrect positioning of a single prosthetic heart valve into the proper anatomical location |
| Device Performance | 30 days | Intended performance of the valve (i.e., no moderate or severe prosthetic valve regurgitation)\* |
| Surgery/intervention related to device | 30 days | Freedom from surgery or intervention related to the device# or to a major vascular or access-related or cardiac structural complication |
| Bleeding | 30 days | Freedom from VARC type 2-4 bleeding |
| All Stroke | 30 days | Number of patients that had stroke |
| Acute Kidney Injury | 30 days | Number of patients that had acute kidney injury (AKI) stage 3 or 4 |
| Total aortic regurgitation | 30 days | Number of patients that had moderate or severe total aortic regurgitation |
| Major Vascular Complication | 30 days | Number of patients that had major vascular, access-related, or cardiac structural complication |
| Permanent pacemaker implantation | 30 days | Number of patients that had these events |
| All-cause mortality | 30 days | All-cause mortality within the first 30 days post index procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device Success | 30 days and 1 year | Freedom from unsuccessful delivery of the device, and retrieval of the delivery system |
| Device Positioning | 30 days and 1 year | Freedom from incorrect positioning of a single prosthetic heart valve into the proper anatomical location |
| Device Performance | 30 days and 1 year | Intended performance of the valve (i.e., no moderate or severe prosthetic valve regurgitation)\* |
| Surgery/intervention related to device | 30 days and 1 year | Freedom from surgery or intervention related to the device# or to a major vascular or access-related or cardiac structural complication |
| Bleeding | 30 days and 1 year | Freedom from VARC type 2-4 bleeding |
| All Stroke | 30 days and 1 year | Number of patients that had stroke |
| Acute Kidney Injury | 30 days and 1 year | Number of patients that had acute kidney injury (AKI) stage 3 or 4 |
| Total aortic regurgitation | 30 days and 1 year | Number of patients that had moderate or severe total aortic regurgitation |
| Major Vascular Complication | 30 days and 1 year | Number of patients that had major vascular, access-related, or cardiac structural complication |
| Permanent pacemaker implantation | 30 days and 1 year | Number of patients that had these events |
| All-cause mortality | 30 days and 1 year | All-cause mortality within the first 30 days post index procedure |
Countries
United States
Contacts
STUDY_CHAIRNir Uriel, MD
Columbia University
PRINCIPAL_INVESTIGATORVinod Thourani, MD
Piedmont Heart Institute
PRINCIPAL_INVESTIGATORRavi Ramana, DO
advocate christ medical center
PRINCIPAL_INVESTIGATORGabriel Sayer, MD
Columbia University
Outcome results
None listed