Aortic stenosis narrowing of the heart’s main valve
Conditions
Interventions
Pivotal Randomized Cohort
Navitor Transcatheter Aortic Valve Implantation (TAVI) System, including the following:
o Navitor Valve (including Navitor Valve (NVTR-23/25/27/29) and Navitor Valve with Vis
Sponsors
St. Jude Medical
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. New York Heart Association (NYHA) Functional Classification of II, III, or IV 2. Subject is of legal age for consent in the host country. 3. Subject has been informed of the nature of the trial, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) or Research Ethics Board (REB) of the respective clinical site. 4. Able and willing to return for required follow-up visits and assessments. 5. Degenerative aortic valve stenosis with echo-derived criteria, defined as: aortic valve area (AVA) of = 1.0 cm2 (or indexed EOA = 0.6 cm2/m2) or either mean gradient = 40 mmHg or peak jet velocity = 4.0 m/s or doppler velocity index (DVI) = 0.25. The echocardiogram supporting the qualifying AVA baseline measurement must be performed within 6 months prior to informed consent. 6. Aortic annulus diameter of 19-30 mm and ascending aorta diameter of 26-44 mm for the specified valve size listed in the IFU, as measured by CT (systolic phase) conducted within 12 months prior to informed consent.Additional Inclusion Criteria for Pivotal Randomized Cohort 7. Subject who is judged by a Heart Team, including a cardiac surgeon, to be appropriate for transcatheter heart valve intervention therapy, and is deemed to be at intermediate or low risk for open surgical aortic valve replacement: a) Intermediate risk: estimated risk of surgical mortality = 3% and < 8% at 30 days b) Low risk: estimated risk of surgical mortality < 3% at 30 days Estimated risk of surgical mortality includes consideration of the Society of Thoracic Surgeons (STS-PROM) risk score, overall clinical status, and other clinical co-morbidities unmeasured by the risk calculator.Additional Inclusion Criteria for ViV Cohort 8. Subject who is judged by a Heart Team, including a cardiac surgeon, to be appropriate for transcatheter heart valve intervention therapy, and is deemed to be at high risk or greater for open surgical aortic valve replacement (i.e., estimated risk of surgical mortality = 8% at 30 days or risk of surgical mortality or major morbidity = 50% at 30 days) Estimated risk of surgical mortality includes consideration of the Society of Thoracic Surgeons (STS-PROM) risk score, overall clinical status, and other clinical co-morbidities unmeasured by the risk calculator 9. Failing aortic bioprosthetic valve that is stenotic or requires replacement due to other forms of structural valve deterioration (i.e., = moderate stenosis and/or = moderate insufficiency)
Exclusion criteria
Exclusion criteria: General Exclusion Criteria 1. Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period. A pregnancy test is required for women of childbearing potential. 2. Need for emergency surgery for any reason 3. In the opinion of the Investigator, life expectancy is less than 2 years. 4. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator’s opinion, could limit the subject’s ability to participate in the clinical trial or to comply with follow up requirements, or impact the scientific soundness of the clinical trial results 5. Incapacitated individuals, defined as persons who are mentally ill, mentally handicapped, individuals with severe dementia or individuals without legal authority 6. Currently participating in an investigational drug or device study that has not reached the primary endpoint or may confound the results of this trial 7. Evidence of an acute myocardial infarction [defined as ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI) with acute ischemia symptoms and troponin elevation] within 30 days prior to index procedure 8. Untreated clinically significant coronary artery disease requiring revascularization 9. Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior (except pacemaker or implantable cardioverter defibrillator (ICD) implant) to index procedure or planned within 30 days following the index procedure. 10. Blood dyscrasias as defined: leukopenia (WBC < 3000 mm3), acute anemia (Hb < 9 g/dL), thrombocytopenia (platelet count < 50,000 cells/mm³); history of bleeding diathesis or coagulopathy 11. Refuses blood products 12. Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support 13. Hemodynamic instability requiring inotropic support or mechanical heart assistance 14. Hypertrophic cardiomyopathy with obstruction 15. Active peptic ulcer or upper GI bleeding within 3 months prior to index procedure that would preclude anticoagulation 16. Known intolerance, hypersensitivity, or contraindication, including subjects that meet any of the following conditions: a) cannot take any antiplatelets or anticoagulants*, b) sensitivity to contrast media which cannot be adequately premedicated, c) known hypersensitivity to nitinol (nickel or titanium), or d) clinical contraindication that precludes contrast CT imaging *Note: Subjects who can take either an antiplatelet or anticoagulant therapy post-procedure will be eligible. 17. Recent (within 6 months prior to index procedure date) cerebrovascular accident (CVA) or a transient ischemic attack (TIA) 18. Renal insufficiency (creatinine > 3.0 mg/dL or eGFR < 30 ml/min/1.73m2) and/or end stage renal disease requiring chronic dialysis 19. Active bacterial endocarditis within 6 months prior to the index procedure 20. Liver failure (Child-Pugh class B or C) 21. Subjects with atrial fibrillation who are not on anticoagulants, or subjects with atrial fibrillation at high stroke risk who are not implanted with a left atrial appendage occlusion (LAAO) device or who have not undergone a left atrial appendage ligation (LAL) procedure. 22. Symptomatic carotid or vertebral artery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Endpoint The primary endpoint is a composite of all-cause mortality or all stroke at 12 months post-procedure per the VARC-3 definitions. Descriptive Endpoints The rate of the following key outcomes will be assessed as descriptive endpoints for the clinical investigation: 1. Non-hierarchical composite of all-cause mortality or all stroke at 30 days 2. Non-hierarchical composite of all-cause mortality, fatal stroke/stroke with disability, type 3/type 4 bleeding, stage 3/stage 4 acute kidney injury, major vascular complications, or major access-related non-vascular complications at 30 days 3. Non-hierarchical composite of all-cause mortality or fatal stroke/stroke with disability at 12 months 4. Technical success (at exit from procedure room) defined as: • Freedom from mortality • Successful access, delivery of the device, and retrieval of the delivery system • Correct positioning of a single prosthetic heart valve into the proper anatomical location • Freedom from surgery or intervention related to the deviceB or to a major vascular or access-related, or cardiac structural complication 5. Device success (at 30 days) defined as: • Technical success • Freedom from mortality • Freedom from surgery or intervention related to the device or to a major vascular or access-related or cardiac structural complication • Intended performance of the valve (mean gradient < 20 mmHg, peak velocity < 3 m/sec, Doppler velocity index = 0.25, and less than moderate aortic regurgitation) 6. Mortality (all-cause, cardiovascular, and valve-related) at 30 days, 12 months, and annually through 5 years (ViV cohort) or 10 years (pivotal randomized cohort). 7. Stroke (All stroke, fatal stroke, stroke with disability, and stroke without disability; ischemic vs. hemorrhagic) at 30 days, 12 months, and annually through 5 years (ViV cohort) or 10 years (pivotal randomized cohort). 8. Transient ischemic attack (TIA) at 30 days and 12 months 9. Overt bleeding (type 4, type 3, and type 2 | — |
Countries
Australia, France, Germany, Israel, Netherlands, Sweden, Switzerland, United States
Contacts
Public ContactD Dedroog
St. Jude Medical
Outcome results
None listed