ADVANCE Direct Aortic Study

Medtronic

Status: Completed

Conditions: Valvular Heart Disease; Aortic Stenosis

Treatments: Device: CoreValve aortic valve

Study type: Observational

Funder types: Industry

Identifiers

NCT01676727

Advance-DA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 1 patient group

CoreValve aortic valve

Description:

Implantation of CoreValve aortic valve via direct aortic approach

Treatment:

Device: CoreValve aortic valve