ADVANCE Direct Aortic (ADVANCE DA)

This study is not yet open for participant recruitment.
Verified August 2012 by Medtronic Bakken Research Center
Sponsor:
Information provided by (Responsible Party):
Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:
NCT01676727
First received: August 29, 2012
Last updated: NA
Last verified: August 2012
History: No changes posted
  Purpose

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.


Condition
Aortic Stenosis
Valvular Heart Disease
Transcatheter Aortic Valve Implantation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: CoreValve® ADVANCE Direct Aortic Study

Resource links provided by NLM:


Further study details as provided by Medtronic Bakken Research Center:

Primary Outcome Measures:
  • All-cause mortality [ Time Frame: 30 days post-implant ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Incidence of Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)-Combined safety endpoint [ Time Frame: 1, 6 and 12 months ] [ Designated as safety issue: Yes ]

    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


Estimated Enrollment: 100
Study Start Date: September 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   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.

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

    -

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01676727

Contacts
Contact: Gwenn Wetzels, PhD +31 (0) 43 3566527 gwenn.wetzels@medtronic.com
Contact: Maarten Hollander, MSc +31 (0) 43 3566864 maarten.hollander@medtronic.com

Locations
Czech Republic
Nemocnice Podlesi Trinec Not yet recruiting
Trinec, Czech Republic, 739 61
Principal Investigator: Marian Branny, M.D.         
Principal Investigator: Piotr Branny, M.D.         
France
Hôpital privé Jacques Cartier Not yet recruiting
Massy, France, 91300
Principal Investigator: Bernard Chevalier, M.D.         
Principal Investigator: Romano Mauro, M.D.         
CHU Rennes Not yet recruiting
Rennes, France, 35033 Cedex 9
Principal Investigator: Jean Philippe Verhoye, M.D.         
Principal Investigator: Herve Le Breton, M.D.         
Hopital de Rangueil Not yet recruiting
Toulouse, France, 31059 CEDEX 9
Principal Investigator: Bertrand Marcheix, M.D.         
Principal Investigator: Nicolas Dumonteil, M.D.         
Germany
Universitätsklinikum Halle (Saale) Not yet recruiting
Halle (Saale), Germany, 06120
Principal Investigator: Hasan Bushnaq, M.D.         
Krankenhaus der Barmherzigen Bruder Not yet recruiting
Trier, Germany, 54292
Principal Investigator: Karl Friedrich, M.D.         
Principal Investigator: Karl Eugen Hauptmann, M.D.         
Italy
Azienda spedaliera Spedali Civili Di Brescia Not yet recruiting
Brescia, Italy, 25123
Principal Investigator: Frederica Ettori, M.D.         
Principal Investigator: Giuseppe Coletti, M.D.         
Azienda spedaliera Niguarda Ca' Granda Milano Not yet recruiting
Milano, Italy, 20162
Principal Investigator: Giuseppe Bruschi, M.D.         
Principal Investigator: Silvio Klugmann, M.D.         
Netherlands
Catharina Ziekenhuis Not yet recruiting
Eindhoven, Netherlands, 5623 EJ
Principal Investigator: Erwin Tan, M.D.         
Principal Investigator: Guus Brueren, M.D.         
Norway
Rikshospitalet HF Not yet recruiting
Oslo, Norway, 0372
Principal Investigator: Gry Dahle, M.D.         
Principal Investigator: Bjorn Bendz, M.D.         
Poland
Śląskie Centrum Chorob Serca Not yet recruiting
Zabrze, Poland, 41-800
Principal Investigator: Marian Zembala, M.D.         
United Kingdom
Royal Brompton & Harefield NHS Trust Not yet recruiting
London, United Kingdom, SW3 6NP
Principal Investigator: Neil Moat, M.D.         
Principal Investigator: Simon William Davies, M.D.         
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Medtronic Bakken Research Center
ClinicalTrials.gov Identifier: NCT01676727     History of Changes
Other Study ID Numbers: V1 04JUN2012
Study First Received: August 29, 2012
Last Updated: August 29, 2012
Health Authority: Czech Republic: Ethics Committee
France: Institutional Ethical Committee
Germany: Ethics Commission
Netherlands: Medical Ethics Review Committee (METC)
Norway: Regional Ethics Commitee
Poland: Ethics Committee
United Kingdom: Research Ethics Committee
Italy: Ethics Committee

Keywords provided by Medtronic Bakken Research Center:
Transcatheter Aortic valve Implantation
Heart Valve Diseases
Cardiovascular Diseases

Additional relevant MeSH terms:
Aortic Valve Stenosis
Heart Diseases
Heart Valve Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction

ClinicalTrials.gov processed this record on April 17, 2014