ADVANCE Direct Aortic (ADVANCE DA)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:
NCT01676727
First received: August 29, 2012
Last updated: June 28, 2014
Last verified: June 2014
  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


Enrollment: 100
Study Start Date: September 2012
Estimated Study Completion Date: June 2015
Primary Completion Date: April 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Czech Republic
Nemocnice Podlesi Trinec
Trinec, Czech Republic, 739 61
France
Hopital de Rangueil
Toulouse, France, 31059 CEDEX 9
Germany
Universitätsklinikum Halle (Saale)
Halle (Saale), Germany, 06120
Italy
Azienda spedaliera Spedali Civili Di Brescia
Brescia, Italy, 25123
Azienda spedaliera Niguarda Ca' Granda Milano
Milano, Italy, 20162
Netherlands
Catharina Ziekenhuis
Eindhoven, Netherlands, 5623 EJ
Medisch centrum Leeuwarden
Leeuwarden, Netherlands
United Kingdom
Brighton and Sussex University Hospitals NHS Trust, Royal Sussex County Hospital
Brighton, United Kingdom
Royal Brompton & Harefield NHS Trust
London, United Kingdom, SW3 6NP
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: Advance-DA
Study First Received: August 29, 2012
Last Updated: June 28, 2014
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:
Heart Diseases
Aortic Valve Stenosis
Heart Valve Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction

ClinicalTrials.gov processed this record on September 22, 2014