Portico NG Approval Study
Symptomatic Severe Aortic Stenosis
About this trial
This is an interventional treatment trial for Symptomatic Severe Aortic Stenosis focused on measuring Aortic Stenosis, Transcatheter Aortic Valve Implantation, Heart Valve Disease, High Surgical Risk, Portico NG (Navitor) Valve, Extreme Surgical Risk, Navitor Titan Valve
Eligibility Criteria
Key Inclusion Criteria:
- Subjects must have a Society of Thoracic Surgeons (STS) score of ≥7% OR documented heart team agreement of high or extreme risk for surgical aortic valve replacement due to frailty or co-morbidities not captured by the STS score.
- Subject has symptomatic aortic stenosis as demonstrated by NYHA (New York Heart Association) Functional Classification of II, III, or IV.
- Subject has senile degenerative aortic valve stenosis with echo-derived criteria, defined as: aortic valve area (AVA) of ≤ 1.0 cm2 (or indexed EOA (effective orifice area) ≤ 0.6 cm2/m2) AND mean gradient ≥40 mmHg or peak jet velocity ≥ 4.0 m/s or doppler velocity index (DVI) ≤0.25. (Qualifying AVA baseline measurement must be within 90 days prior to informed consent).
- Aortic annulus diameter of 19-30mm and ascending aorta diameter for the specified valve size listed in the IFU (Instructions For Use), as measured by CT (Computed Tomography)
Key Exclusion Criteria:
- Evidence of an acute myocardial infarction (defined as: ST Segment Elevation as evidenced on 12 Lead ECG) within 30 days prior to index procedure.
- Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to index procedure.
- 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
- Active peptic ulcer or upper GI bleeding within 3 months prior to index procedure that would preclude anticoagulation
- Recent (within 6 months prior to index procedure date) cerebrovascular accident (CVA) or a transient ischemic attack (TIA).
- Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation 3-4+).
- Pre-existing prosthetic heart valve or other implant in any valve position, prosthetic ring, severe circumferential mitral annular calcification (MAC) which is continuous with calcium in the left ventricular outflow tract (LVOT), severe (greater than or equal to 3+) mitral insufficiency, or severe mitral stenosis with pulmonary compromise.
- Minimum access vessel diameter of <5.0mm for small FlexNav™ Delivery System and <5.5 mm for large FlexNav™ Delivery System
Sites / Locations
- Cedars-Sinai Medical Center
- Los Robles Regional Medical Center
- Washington Hospital Center
- Advocate Christ Medical Center
- St. Vincent Hospital
- Cardiovascular Research Institute of Kansas
- Sparrow Clinical Research Institute
- Minneapolis Heart Institute
- Atlantic Health System - Morristown Memorial Hospital
- Albany Medical Center
- Columbia University Medical Center/NYPH
- Montefiore Medical Center - Moses Division
- Mission Health & Hospitals
- University Hospitals Cleveland Medical Center
- Providence St. Vincent Medical Center
- University of Pittsburgh Medical Center
- Baptist Memorial Hospital
- Vanderbilt University Medical Center
- The Methodist Hospital
- The Heart Hospital Baylor Plano
- Intermountain St. George Regional Hospital
- Sentara Norfolk General Hospital
- St. Andrew's Hospital
- The Alfred Hospital
- Fiona Stanley Hospital
- Rigshospitalet
- Policlinico San Donato
- Royal Victoria Hospital
- Morriston Hospital - ABM University Health Board
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Portico™ NG (Navitor) valve, FlexNav™ Delivery System
Navitor Titan Valve
Portico ™ NG (Navitor) valve implantation with the new generation Portico NG (Navitor) valve (23mm, 25mm, 27mm and 29mm sizes), and the second-generation FlexNav Delivery system (small and large), Portico™ NG (Navitor) Loading System(s) (small and large).
Navitor Titan Valve (35mm) implantation with the large FlexNav Delivery system and Navitor Loading System - LG+.