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

August 29, 2012
June 28, 2014
September 2012
April 2014   (final data collection date for primary outcome measure)
All-cause mortality [ Time Frame: 30 days post-implant ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01676727 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
ADVANCE Direct Aortic
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. 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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

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.

  • Aortic Stenosis
  • Valvular Heart Disease
  • Transcatheter Aortic Valve Implantation
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
June 2015
April 2014   (final data collection date for primary outcome measure)

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

    -

Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Czech Republic,   France,   Germany,   Italy,   Netherlands,   United Kingdom
 
NCT01676727
Advance-DA
Not Provided
Medtronic Bakken Research Center
Medtronic Bakken Research Center
Not Provided
Principal Investigator: Neil Moat, M.D. The Royal Brompton Hospital
Principal Investigator: Giuseppe Bruschi, M.D. Azienda spedaliera Niguarda Ca' Granda Milano
Medtronic Bakken Research Center
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP