Clinical trial NCT01676727: ADVANCE Direct Aortic Study
Official title: CoreValve® ADVANCE Direct Aortic Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Stenosis
Valvular Heart Disease
Keywords: Transcatheter Aortic valve Implantation
Heart Valve Diseases
Cardiovascular Diseases
Lead sponsor: Medtronic Cardiovascular
Sponsor class: INDUSTRY
First posted: 2012-08-31
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Severe symptomatic aortic valve stenosis requiring treatment
2. Acceptable candidate for elective treatment with the Medtronic CoreValve® System according to the most recent version of the Medtronic CoreValve® Instructions For Use
3. 21 years of age or older
4. Patient is willing and able to comply with all protocol-specified follow-up evaluations
5. 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")
6. Patient will receive the CoreValve® device via direct aortic approach TAVI -

Exclusion Criteria:

1. Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, clopidogrel, nitinol, or sensitivity to contrast media which cannot be adequately pre-medicated
2. Sepsis, including active endocarditis
3. Recent myocardial infarction (\<30 days)
4. Left ventricular or atrial thrombus by echocardiography
5. Uncontrolled atrial fibrillation
6. Mitral or tricuspid valvular insufficiency (\>grade II)
7. Previous aortic valve replacement (mechanical valve or stented bioprosthetic valve)
8. Evolutive or recent (within 6 months of implant procedure) cerebrovascular accident (CVA) or transient ischemic attack (TIA)
9. Patients with:

   1. Vascular conditions that make insertion and endovascular access to the aortic valve impossible, or
   2. Symptomatic carotid or vertebral arterial narrowing (\>70%) disease, or
   3. Thoracic aortic aneurysm in the path of delivery system
10. Bleeding diathesis or coagulopathy
11. Patient refuses blood transfusion
12. Estimated life expectancy of less than 12 months unless TAVI is performed
13. Creatine clearance \<20 mL/min
14. Active gastritis or peptic ulcer disease
15. Pregnancy or intent to become pregnant during study follow up
16. Patient is participating in another trial that may influence the results of this study

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Primary outcomes:
measure: All-cause Mortality
timeFrame: 30 days post-implant
Secondary outcomes:
measure: Kaplan-Meier Estimate of Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
timeFrame: 1, 6 and 12 months
Other outcomes:
Locations:
city: Trinec
country: Czechia
facility: Nemocnice Podlesi Trinec
city: Toulouse
country: France
facility: Hopital de Rangueil
city: Halle (Saale)
country: Germany
facility: Universitätsklinikum Halle (Saale)
city: Brescia
country: Italy
facility: Azienda spedaliera Spedali Civili Di Brescia
city: Milano
country: Italy
facility: Azienda spedaliera Niguarda Ca' Granda Milano
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
city: Leeuwarden
country: Netherlands
facility: Medisch centrum Leeuwarden
city: Brighton
country: United Kingdom
facility: Brighton and Sussex University Hospitals NHS Trust, Royal Sussex County Hospital
city: London
country: United Kingdom
facility: Royal Brompton & Harefield NHS Trust
Study officials:
affiliation: The Royal Brompton Hospital
name: Neil Moat, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Azienda spedaliera Niguarda Ca' Granda Milano
name: Giuseppe Bruschi, M.D.
role: PRINCIPAL_INVESTIGATOR
References: