ADVANCE Direct Aortic Study

NCT01676727 | Completed Results

• 1 other identifier: Advance-DA
• Study Type: observational
• Target: 100
• Locations: 6 countries
• Sites: 9

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.

Conditions

Aortic Stenosis; Valvular Heart Disease

Keywords

Transcatheter Aortic valve Implantation; Heart Valve Diseases; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

• All-cause Mortality

  Kaplan-Meier estimate of 30-day all-cause mortality.

  30 days post-implant

Secondary Outcomes (1)

• Kaplan-Meier Estimate of Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)

  1, 6 and 12 months

Study Arms (1)

CoreValve aortic valve

Implantation of CoreValve aortic valve via direct aortic approach

Device: CoreValve aortic valve

Interventions

CoreValve aortic valve DEVICE

Implantation of CoreValve aortic valve via direct aortic approach

CoreValve aortic valve

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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
• 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 -

You may not qualify if:

• 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 (\<30 days)
• Left ventricular or atrial thrombus by echocardiography
• Uncontrolled atrial fibrillation
• Mitral or tricuspid valvular insufficiency (\>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

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (9)

Nemocnice Podlesi Trinec

Třinec, 739 61, Czechia

Location

Hopital de Rangueil

Toulouse, 31059 CEDEX 9, France

Location

Universitätsklinikum Halle (Saale)

Halle, 06120, Germany

Location

Azienda spedaliera Spedali Civili Di Brescia

Brescia, 25123, Italy

Location

Azienda spedaliera Niguarda Ca' Granda Milano

Milan, 20162, Italy

Location

Catharina Ziekenhuis

Eindhoven, 5623 EJ, Netherlands

Location

Medisch centrum Leeuwarden

Leeuwarden, Netherlands

Location

Brighton and Sussex University Hospitals NHS Trust, Royal Sussex County Hospital

Brighton, United Kingdom

Location

Royal Brompton & Harefield NHS Trust

London, SW3 6NP, United Kingdom

Location

MeSH Terms

Conditions

Aortic Valve Stenosis; Heart Valve Diseases; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Diseases; Ventricular Outflow Obstruction

Results Point of Contact

• Title: Maarten Hollander
• Organization: Medtronic Bakken Research Center

Maarten.Hollander@medtronic.com

+31620534428

Study Officials

• Neil Moat, M.D.

  The Royal Brompton Hospital

  PRINCIPAL INVESTIGATOR

• Giuseppe Bruschi, M.D.

  Azienda spedaliera Niguarda Ca' Granda Milano

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2012
• First Posted: August 31, 2012
• Study Start: September 1, 2012
• Primary Completion: April 1, 2014
• Study Completion: August 1, 2015
• Last Updated: September 19, 2018
• Results First Posted: July 30, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

NL (2); GB (2); CZ (1); FR (1); IT (2); DE (1)