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

Medtronic logo

Medtronic

Status

Completed

Conditions

Aortic Valve Stenosis

Treatments

Device: Medtronic CoreValve System

Study type

Interventional

Funder types

Industry

Identifiers

NCT01051518
COR-2006-02

Details and patient eligibility

About

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.

Enrollment

126 patients

Sex

All

Ages

75+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

126 participants in 1 patient group

CoreValve
Experimental group
Treatment:
Device: Medtronic CoreValve System

Trial contacts and locations

9

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Data sourced from clinicaltrials.gov

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