Aortic Stenosis
Conditions
Interventions
None listed
Sponsors
Masumoto Naohiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - The patient is scheduled to undergo a Navitor TAVI procedure. - The patient has been informed of the nature of the study, agrees to its provisions,and has provided written informed consent as approved by the IRB (InvestigationalReview Board)/EC (Ethics Committee) of the respe ctive clinical site. - The patient and the treating physician agree that the subject will return for all required post procedure follow up visits.
Exclusion criteria
Exclusion criteria: Life expectancy < 12 months from the time of informed consent due to non-cardiac co-morbid conditions. - In the judgment of the Investigator, patient presents with a medical, social, or psychological condition that could limit the ability or willingness to participate in the study, comply with study required testing and/or follow-up visits or that could impact scientific integrity of the study. - Known contraindication for computed tomography (CT) or sensitivity to contrast media, which cannot be adequately premedicated. - Inability to tolerate antiplatelet/anticoagulation therapy or nitinol alloy (nickel and titanium), which cannot be adequately premedicated. - Currently participating in an investigational drug or device study that may confound the results of this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Moderate or greater paravalvular leak at 30 days post-TAVI procedure [Time Frame: 30 days post ind ex procedure] All-cause mortality at 30 days post-TAVI procedure [Time Frame: 30 days post index procedure] | — |
Countries
Australia, Canada, France, Germany, Italy, Japan, Portugal, Spain, Swwitzerland, UK
Contacts
Public ContactNaohiro Masumoto
Abbott Medical Japan
Outcome results
None listed