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ClinicalTrials.gov Identifier: NCT01676727
Recruitment Status :
First Posted : August 31, 2012
Last Update Posted : October 27, 2015
Medtronic Bakken Research Center
Information provided by (Responsible Party):
Medtronic Cardiovascular ( Medtronic Bakken Research Center )
This study is intended to collect data regarding the clinical utility, safety and performance of the Medtronic CoreValve® System for Transcatheter Aortic Valve Implantation (TAVI) in patients with severe symptomatic aortic valve stenosis for which treatment via direct aortic access (DA) is selected. As part of the study analysis, resource utilization together with the Quality of Life questionnaires data will provide an important input into cost effectiveness analysis.
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Ages Eligible for Study:
21 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients with severe aortic stenosis who are scheduled for an elective transcatheter aortic valve implantation and who are selected (e.g. because of an calcified femoral artery) to receive the CoreValve® device via direct aortic access.
Severe symptomatic aortic valve stenosis requiring treatment
Acceptable candidate for elective treatment with the Medtronic CoreValve® System according to the most recent version of the Medtronic CoreValve® Instructions For Use
21 years of age or older
Patient is willing and able to comply with all protocol-specified follow-up evaluations
The patient or legal representative has been informed of the nature of the study and has consented to participate, and has authorized the collection and release of his/her medical information by signing a consent form ("Patient Informed Consent Form")
Patient will receive the CoreValve® device via direct aortic approach TAVI -
Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, clopidogrel, nitinol, or sensitivity to contrast media which cannot be adequately pre-medicated
Sepsis, including active endocarditis
Recent myocardial infarction (<30 days)
Left ventricular or atrial thrombus by echocardiography
Uncontrolled atrial fibrillation
Mitral or tricuspid valvular insufficiency (>grade II)
Previous aortic valve replacement (mechanical valve or stented bioprosthetic valve)
Evolutive or recent (within 6 months of implant procedure) cerebrovascular accident (CVA) or transient ischemic attack (TIA)
Vascular conditions that make insertion and endovascular access to the aortic valve impossible, or
Symptomatic carotid or vertebral arterial narrowing (>70%) disease, or
Thoracic aortic aneurysm in the path of delivery system
Bleeding diathesis or coagulopathy
Patient refuses blood transfusion
Estimated life expectancy of less than 12 months unless TAVI is performed
Creatine clearance <20 mL/min
Active gastritis or peptic ulcer disease
Pregnancy or intent to become pregnant during study follow up
Patient is participating in another trial that may influence the results of this study