The purpose of this study is to assess the safety and effectiveness of the SJM Portico Transcatheter Heart Valve and the SJM TAVI Transfemoral Transcatheter delivery system in subjects with severe symptomatic aortic stenosis (AS).
Data will be collected at baseline, procedure, discharge, 30 days post implant, 3 months post implant, 6 months post implant, and 12 months post implant.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
222
Placement of the SJM Portico aortic valve with a transfemoral delivery system
Adelaide Royal Hospital
Adelaide, Australia
Rigshospitalet Copenhagen
Copenhagen, Denmark
Kerckhoff Klinik
Bad Nauheim, Germany
All Cause Mortality
Number of participants that reported all cause mortality
Time frame: 30 days
Number of Select Cardiovascular Adverse Events
Number of participants with select cardiovascular adverse events
Time frame: 30 days
Participant NYHA Classification at Day 30
The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. Patients with cardiac disease but without resulting limitation of physical activity. Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest. The Criteria Committee of the New York Heart Association. Nomenclature and Criteria for Diagnosis of Diseases of the Heart and Great Vessels. 9th ed. Boston, Mass: Little, Brown \& Co; 1994:253-256.
Time frame: day 30
Number of Participants With Acute Device Success
1. Successful vascular access, delivery and deployment of the device and successful retrieval of the delivery system 2. Correct position of the device in the proper anatomical location 3. Intended performance of the prosthetic heart valve (Aortic Valve Area \>1.2 cm2 and mean aortic valve gradient \<20 mmHg or peak velocity \<3 m/s, without moderate or severe prosthetic valve AR) 4. Only one valve implanted in the proper anatomical location
Time frame: 7 days
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Bernau, Germany
Asklepios Klinik-St. Georg
Hamburg, Germany
Klinikum der Universität Jena
Jena, Germany
Klinik fur Herzhirurgie Karlruhe GmbH
Karlsruhe, Germany
Herzzentrum Leipzig
Leipzig, Germany
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Leeuwarden, Netherlands
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...and 4 more locations