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
  Purpose

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


Condition Intervention
Aortic Valve Stenosis
Device: Medtronic CoreValve® System

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: CoreValve® System Australia/New Zealand Clinical Study

Resource links provided by NLM:


Further study details as provided by Medtronic Heart Valves:

Primary Outcome Measures:
  • Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) rate and Cardiac Death [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 900
Study Start Date: August 2008
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CoreValve® Implantation
Patients with symptomatic severe aortic stenosis who have an elevated surgical risk
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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01015612

Locations
Australia, New South Wales
St. Vincents Sydney
Darlinghurst, New South Wales, Australia
Australia, Queensland
Prince Charles Hospital
Chermside, Queensland, Australia
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Australia, Victoria
Monash Hospital
Clayton, Victoria, Australia
St. Vincent's Melbourne
Fitzroy, Victoria, Australia
Epworth Hospital
Melbourne, Victoria, Australia, 3004
Alfred Hospital
Melbourne, Victoria, Australia
Australia, Western Australia
Royal Perth Hospital
Perth, Western Australia, Australia
New Zealand
Mercy Hospital
Auckland, New Zealand
Waikato Hospital
Hamilton, New Zealand
Sponsors and Collaborators
Medtronic Heart Valves
Medtronic Australasia
Investigators
Principal Investigator: Ian T Meredith, MD MonashHeart Medical Center
Study Director: Eric Vang Medtronic
  More Information

Publications:
Bonow RO, Carabello BA, Chatterjee K, de Leon AC Jr, Faxon DP, Freed MD, Gaasch WH, Lytle BW, Nishimura RA, O'Gara PT, O'Rourke RA, Otto CM, Shah PM, Shanewise JS; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2008 focused update incorporated into the ACC/AHA 2006 guidelines for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to revise the 1998 guidelines for the management of patients with valvular heart disease). Endorsed by the Society of Cardiovascular Anesthesiologists, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. J Am Coll Cardiol. 2008 Sep 23;52(13):e1-142. No abstract available.

Responsible Party: Medtronic Heart Valves
ClinicalTrials.gov Identifier: NCT01015612     History of Changes
Other Study ID Numbers: CV-PAVR-R2007
Study First Received: November 17, 2009
Last Updated: September 10, 2014
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Australia: Human Research Ethics Committee

Keywords provided by Medtronic Heart Valves:
Aortic Valve Stenosis
Aortic Valve Insufficiency

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

ClinicalTrials.gov processed this record on October 22, 2014