N/A
N=100
ADVANCE Direct Aortic Study
Aortic Stenosis · Valvular Heart Disease
Bottom Line
View on ClinicalTrials.gov: NCT01676727 ↗Enrolled (actual)
100
Serious AEs
78.3%
Results posted
Jul 2018
Primary outcome: Primary: All-cause Mortality — 4.4 Percentage of subjects
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- CoreValve aortic valve (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Primary completion
- Apr 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY All-cause Mortality |
4.4 | — |
| SECONDARY Kaplan-Meier Estimate of Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) |
7.6; 17.6; 19.9 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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 -
Exclusion Criteria
- 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 ( 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)
- Patients with:
- 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
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Data sourced from ClinicalTrials.gov (NCT01676727). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.