Clinical Evaluation of Percutaneous Implantation of the Medtronic CoreValve Aortic Valve Prosthesis (18Fr-Study)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:
NCT01051518
First received: January 15, 2010
Last updated: August 30, 2013
Last verified: August 2013
  Purpose

The investigation concerns a prospective, multicenter, single arm safety and performance study evaluating the Medtronic CoreValve system. Approximately 120 patients presenting with symptomatic aortic native valve stenosis necessitating valve replacement which are considered poor surgical candidates, with a high surgical risk, as attested to by both the surgeon and the cardiologist are recruited in the study.

Safety and performance will be evaluated at discharge and at 30 days post-procedure. Valve performance and placement will be followed up at 3 and 6 months post-procedure. Further long-term patient follow-up visits will be performed at 12, 24, 36 and 48 months post-procedure.


Condition Intervention Phase
Aortic Valve Stenosis
Device: Medtronic CoreValve System
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Percutaneous Implantation of the CoreValve Aortic Valve Prosthesis. Safety and Performance Study on Patients at High Risk for Surgical Valve Replacement (18Fr Safety and Efficacy Study)

Resource links provided by NLM:


Further study details as provided by Medtronic Bakken Research Center:

Primary Outcome Measures:
  • Composite Major Adverse Events (MAE) [ Time Frame: Discharge and 30-days ] [ Designated as safety issue: Yes ]

Enrollment: 126
Study Start Date: May 2006
Study Completion Date: June 2013
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CoreValve Device: Medtronic CoreValve System
Transcatheter Aortic Valve
Other Names:
  • Medtronic CoreValve Trancatheter Aortic Valve
  • Medtronic CoreValve Percutaneous Aortic Valve

  Eligibility

Ages Eligible for Study:   75 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Native aortic valve disease, defined as valve stenosis with an aortic valve area <1cm² (<0.6cm2/m2) as determined by echocardiographic measure,
  • ≥ 75 years, or
  • Surgical risk calculated with logistic EuroSCORE ≥ 15 %, or
  • One or two (but not more than 2) of the following complicating factors:

    1. Cirrhosis of the liver (Child class A or B),
    2. Pulmonary insufficiency : Forced expiratory volume in one second (FEV1) < 1 liter,
    3. Previous cardiac surgery (Coronary artery bypass grafting (CABG), valvular surgery),
    4. Pulmonary hypertension > 60 mmHg and high risk of cardiac surgery other than valve replacement,
    5. Porcelain aorta
    6. Recurrent pulmonary embolus,
    7. Right ventricular insufficiency,
    8. Thoracic burning sequelae contraindicating open chest surgery,
    9. History of mediastinum radiotherapy,
    10. Severe connective tissue disease resulting in a contraindication to surgery,
    11. Cachexia (BMI ≤ 18 kg/m²),
  • Aortic valve annulus diameter is ≥ 20 mm and ≤ 27 mm as determined by echocardiographic measure,
  • Ascending aorta diameter £ 45 mm at the sino-tubular junction, and
  • Signed Informed Consent.

Exclusion Criteria:

  • Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, clopidogrel, Nitinol, or sensitivity to contrast media which cannot be adequately pre-medicated,
  • Any sepsis, including active endocarditis,
  • Recent myocardial infarction (< 30 days),
  • Percutaneous coronary or vascular intervention within 15 days prior to the study procedure, or scheduled during or within 30 days after the study procedure,
  • Any left ventricular or atrial thrombus diagnosed by echocardiography,
  • Uncontrolled atrial fibrillation (heart rate greater than 100 bpm),
  • Mitral or tricuspid valvular insufficiency ( > grade II),
  • Previous aortic valve replacement (mechanical valve OR stented bioprosthetic valve),
  • Any condition considered as contraindication for extracorporeal assistance,
  • Evolutive or recent CVA (cerebro vascular accident),
  • Poly arterial patients with either:

    1. Femoral, iliac or aortic vascular condition (e.g. stenosis, tortuosity), that make insertion and endovascular access to the aortic valve impossible, or
    2. Symptomatic carotid or vertebral arteries narrowing (> 70%) disease, or
    3. Abdominal or thoracic aortic aneurysm,
  • Bleeding diathesis or coagulopathy, or patient who will refuse blood transfusion,
  • Evolutive disease with life expectancy less than one year,
  • Creatinine clearance < 20 ml/min,
  • Pregnancy, and
  • Enrolled in another investigational 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: NCT01051518

Locations
Canada
University of Alberta Hospital
Edmonton, Canada
Institut de Cardiologie de Montreal
Montreal, Canada
University of Ottawa Heart Institute
Ottawa, Canada
Germany
Herzzentrum Leipzig GmbH
Leipzig, Germany
HELIOS Heart Center Siegburg
Siegburg, Germany
Netherlands
Amphia Hospital
Breda, Netherlands
Erasmus MC
Rotterdam, Netherlands
United Kingdom
Glenfield Hospital
Leicester, United Kingdom
Royal Brompton & Harefield NHS Trust
London, United Kingdom
Sponsors and Collaborators
Medtronic Bakken Research Center
Investigators
Principal Investigator: E. Grube, Prof. Dr. Helios Heart Center Siegburg, Germany
Principal Investigator: G. Schuler, Prof. Dr. Herzzentrum Universitat Leipzig, Germany
Principal Investigator: R. Bonan, Dr. Institut de Cardiologie de Montreal, Canada
Principal Investigator: J. Kovac, Dr. Glenfield Hospital Leicester, UK
Principal Investigator: P. Serruys, Prof. Dr. Erasmus MC Rotterdam, Netherlands
Principal Investigator: M. Labinaz, Dr. University of Ottawa Heart Institute, Canada
Principal Investigator: P den Heijer, Dr. Amphia Hospital Breda, Netherlands
Principal Investigator: M Mullen, Dr. Royal Brompton & Harefield NHS Trust London, UK
Principal Investigator: W. Tymchak, Dr. University of Alberta Hospital, Canada
  More Information

Additional Information:
No publications provided

Responsible Party: Medtronic Bakken Research Center
ClinicalTrials.gov Identifier: NCT01051518     History of Changes
Other Study ID Numbers: COR-2006-02
Study First Received: January 15, 2010
Last Updated: August 30, 2013
Health Authority: Netherlands: Ministry of Health, Welfare and Sport
Germany: Ministry of Health
United Kingdom: Department of Health
Canada: Health Canada

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

ClinicalTrials.gov processed this record on August 01, 2014