CoreValve® System Australia/New Zealand Clinical Study

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Medtronic Australasia
Information provided by (Responsible Party):
Medtronic Heart Valves
ClinicalTrials.gov Identifier:
NCT01015612
First received: November 17, 2009
Last updated: September 10, 2014
Last verified: September 2014

November 17, 2009
September 10, 2014
August 2008
September 2014   (final data collection date for primary outcome measure)
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) rate and Cardiac Death [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
Freedom from Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) rate [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01015612 on ClinicalTrials.gov Archive Site
  • Freedom from Conversion to Surgery [ Time Frame: 30 Days, 6, 12, 24 months ] [ Designated as safety issue: Yes ]
  • Freedom from MACCE [ Time Frame: 30 days, 6, 12, 24 months ] [ Designated as safety issue: Yes ]
  • Conduction disturbances [ Time Frame: 30 days, 6, 12, 24 months ] [ Designated as safety issue: Yes ]
  • Various echocardiogram measurements of replacement valve functionality [ Time Frame: 30 days, 6, 12, 24 months ] [ Designated as safety issue: No ]
  • NYHA Class Improvement [ Time Frame: 30 days, 6, 12, 24 months ] [ Designated as safety issue: No ]
  • All Cause Mortality [ Time Frame: In hospital, 30 days, 6, 12, 24 months ] [ Designated as safety issue: Yes ]
  • Cardiac Mortality [ Time Frame: In Hospital, 30 days, 6,12, 24 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
CoreValve® System Australia/New Zealand Clinical Study
CoreValve® System Australia/New Zealand Clinical Study

To evaluate the performance, efficacy and safety of the percutaneous implantation of the CoreValve® prosthetic aortic valve in patients with severe symptomatic native aortic valve stenosis that have an elevated surgical risk

Prospective, non-randomized, single-arm multi-center trial conducted under a common protocol at 10 centers in Australia and New Zealand.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Aortic Valve Stenosis
Device: Medtronic CoreValve® System
The CoreValve® device is designed to replace the native aortic valve without the requirement for open heart surgery and without concomitant surgical removal of the failed native valve in patients with symptomatic severe aortic stenosis who have an elevated surgical risk
Experimental: CoreValve® Implantation
Patients with symptomatic severe aortic stenosis who have an elevated surgical risk
Intervention: Device: Medtronic CoreValve® System

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
900
September 2016
September 2014   (final data collection date for primary outcome measure)

Inclusion Criteria

  1. Documented severe aortic valve stenosis
  2. Access vessel diameter >6 mm as defined pre procedure via angiographic measure
  3. Aortic valve annulus diameter ≥ 20 mm and < 29 mm as defined pre procedure by echocardiographic measure
  4. Ascending aorta diameter ≤ 43 mm at the sino-tubular junction
  5. Native aortic valve disease, defined as valve stenosis with an aortic valve area <1cm2 (<0.6cm2 /m2) as defined pre procedure by echocardiographic measure

    AND (Assessment of Surgical Risk)

    Age ≥ 80 years

    AND/OR

    Surgical risk calculated with logistic EuroSCORE ≥ 20%,

    AND/OR

    Age ≥ 65 years with one or two (but not more than 2) of the following criteria:

    • Cirrhosis of the liver (Child class A or B)
    • Pulmonary insufficiency : VMS < 1 liter
    • Previous cardiac surgery (CABG, valvular surgery)
    • Porcelain aorta
    • Pulmonary hypertension > 60 mmHg and high probability of cardiac surgery for other than valve replacement
    • Recurrent pulmonary embolus
    • Right ventricular insufficiency
    • Thoracic burning sequelae contraindicating open chest surgery
    • History of mediastinum radiotherapy
    • Severe connective tissue disease resulting in a contraindication to surgery
    • Cachexia (clinical impression)
  6. Study subjects must be willing and able to attend all follow-up visits within specified visit windows, and agree to undergo all protocol evaluations at each visit

Exclusion Criteria:

  1. Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, clopidogrel, nitinol, porcine products, or contrast media which cannot be adequately pre-medicated
  2. Any sepsis, including active endocarditis.
  3. Recent myocardial infarction (<30 days)
  4. Any left ventricular or atrial thrombus as determined pre procedure 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 CVA (cerebrovascular accident), (<3 months)
  9. Femoral, iliac or aortic vascular condition (e.g. stenosis, tortuosity), that make impossible insertion and endovascular access to the aortic valve
  10. Symptomatic carotid or vertebral arteries narrowing (> 70%) disease
  11. Abdominal or thoracic aortic aneurysm
  12. Bleeding diathesis or coagulopathy, or patient will refuse blood transfusion
  13. Evolutive disease with life expectancy less than one year
  14. Creatinine clearance < 20 ml/min
  15. Active gastritis or known peptic ulcer disease
  16. Pregnancy
Both
65 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia,   New Zealand
 
NCT01015612
CV-PAVR-R2007
Yes
Medtronic Heart Valves
Medtronic Heart Valves
Medtronic Australasia
Principal Investigator: Ian T Meredith, MD MonashHeart Medical Center
Study Director: Eric Vang Medtronic
Medtronic Heart Valves
September 2014

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