ADVANCE Direct Aortic Study

CoreValve® ADVANCE Direct Aortic Study

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.

Study Overview

• Status: Completed
• Conditions: Aortic Stenosis; Valvular Heart Disease
• Intervention / Treatment: Device: CoreValve aortic valve

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 Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Czechia
  • Trinec, Czechia, 739 61
    • Nemocnice Podlesi Trinec
• France
  • Toulouse, France, 31059 CEDEX 9
    • Hôpital de Rangueil
• Germany
  • Halle (Saale), Germany, 06120
    • Universitatsklinikum Halle (Saale)
• Italy
  • Brescia, Italy, 25123
    • Azienda spedaliera Spedali Civili Di Brescia
  • Milano, Italy, 20162
    • Azienda spedaliera Niguarda Ca' Granda Milano
• Netherlands
  • Eindhoven, Netherlands, 5623 EJ
    • Catharina Ziekenhuis
  • Leeuwarden, Netherlands
    • Medisch Centrum Leeuwarden
• United Kingdom
  • Brighton, United Kingdom
    • Brighton and Sussex University Hospitals NHS Trust, Royal Sussex County Hospital
  • London, United Kingdom, SW3 6NP
    • Royal Brompton & Harefield NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CoreValve aortic valve; Implantation of CoreValve aortic valve via direct aortic approach	Device: CoreValve aortic valve; Implantation of CoreValve aortic valve via direct aortic approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause Mortality	Kaplan-Meier estimate of 30-day all-cause mortality.	30 days post-implant

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Kaplan-Meier Estimate of Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)	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	1, 6 and 12 months

Collaborators and Investigators

• Sponsor: Medtronic Bakken Research Center
• Investigators: Principal Investigator: Neil Moat, M.D., The Royal Brompton Hospital; Principal Investigator: Giuseppe Bruschi, M.D., Azienda spedaliera Niguarda Ca' Granda Milano

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: August 29, 2012
• First Submitted That Met QC Criteria: August 29, 2012
• First Posted (Estimate): August 31, 2012

Study Record Updates

• Last Update Posted (Actual): September 19, 2018
• Last Update Submitted That Met QC Criteria: August 20, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Cardiovascular Diseases; Heart Valve Diseases; Transcatheter Aortic valve Implantation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Aortic Valve Disease; Ventricular Outflow Obstruction; Heart Diseases; Aortic Valve Stenosis; Heart Valve Diseases
• Other Study ID Numbers: Advance-DA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No