ADVANCE Direct Aortic Study

Completed

• Conditions: Aortic Stenosis; Valvular Heart Disease

• Registration Number: NCT01676727
• Lead Sponsor: Medtronic Bakken Research Center

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.

Study Timeline

• Study First Submitted: 2012-08-29
• Study First Submitted QC: 2012-08-29
• Study First Posted: 2012-08-31
• Study Start: 2012-09
• Primary Completion: 2014-04
• Study Completion: 2015-08
• Results First Submitted: 2016-09-06
• Results First Submitted QC: 2017-10-27
• Results First Posted: 2018-07-30
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-20
• Last Update Posted: 2018-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All-cause Mortality	30 days post-implant	Kaplan-Meier estimate of 30-day all-cause mortality.

Secondary Outcome Measures

Name	Time	Method
Kaplan-Meier Estimate of Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)	1, 6 and 12 months	The combined safety endpoint is defined as a composite of: * All-cause mortality; * All stroke; * Life-threatening bleeding; * Acute kidney injury-Stage 3 (including renal replacement therapy); * Coronary artery obstruction requiring intervention; * Major vascular complication; * Valve-related dysfunction requiring repeat procedure (BAV, TAVR, or SAVR); * High degree AV block requiring permanent pacemaker implantation

Trial Locations

Locations (9)

Nemocnice Podlesi Trinec; 🇨🇿 Trinec, Czechia

Hopital de Rangueil; 🇫🇷 Toulouse, France

Universitätsklinikum Halle (Saale); 🇩🇪 Halle (Saale), Germany

Azienda spedaliera Spedali Civili Di Brescia; 🇮🇹 Brescia, Italy

Azienda spedaliera Niguarda Ca' Granda Milano; 🇮🇹 Milano, Italy

Catharina Ziekenhuis; 🇳🇱 Eindhoven, Netherlands

Medisch centrum Leeuwarden; 🇳🇱 Leeuwarden, Netherlands

Brighton and Sussex University Hospitals NHS Trust, Royal Sussex County Hospital; 🇬🇧 Brighton, United Kingdom

Royal Brompton & Harefield NHS Trust; 🇬🇧 London, United Kingdom