Medtronic CoreValve REDO Study
Medtronic CoreValve REDO Study
The proposed investigation is a prospective, multicenter, non-randomized study to evaluate
 the immediate benefits (at discharge and at 30 days) in terms of performance and safety of
 the implantation of the Medtronic CoreValve PAV in a failing aortic bioprosthesis. In
 addition, the study aims to evaluate the performance and the safety of the implantation of
 the Medtronic CoreValve PAV in a failing aortic bioprosthesis at subsequent annual follow-ups
 out to 48 months post procedure.

 These objectives will be achieved through the following endpoints:

 -  Primary safety endpoint - Composite of Major Adverse Events

 -  Primary performance endpoint - Technical and procedural success at discharge

 Patient Population: Eligible subjects will be at least 75 years old, presenting with a
 failing aortic bioprosthesis (stenotic, incompetent or mixed) including homograft or stented
 or stentless heterograft, considered poor surgical candidates and necessitating repeat aortic
 valve replacement. Up to 20 patients will be included in up to four hospitals.
Inclusion Criteria:

 -  > 74 years old,

 -  Symptomatic failing bioprosthetic aortic valve (stenotic, incompetent or mixed)
 confirmed by Doppler echocardiography,

 -  Logistic EuroSCORE > 15%, or

 -  Any of the following criteria:

 1. Left ventricular ejection fraction (LVEF) < 20%,

 2. Creatinine clearance < 20mL/min (estimation using the Cockcroft calculation),

 3. Renal failure requiring dialysis,

 4. Permanent and long lasting (> 6 month duration) atrial fibrillation,

 5. Cirrhosis of the liver (Child class A or B),

 6. Respiratory impairment (FEV1 < 1L),

 7. Previous cardiac surgery (i.e., CABG especially if patient had competent mammary
 arteries on left anterior descending (LAD) artery or occluded saphenous veins
 with high-risk of coronary embolism during re-operation),

 8. Pulmonary hypertension ³ 60mmHg,

 9. Recurrent pulmonary embolus,

 10. Moderate tricuspid (< grade 2+) insufficiency,

 11. Any severe disease contraindicating surgery,

 12. Calcified aorta (porcelain aorta),

 13. Recent myocardial infarction (less than 30 days at baseline),

 14. Contraindication for cardiopulmonary bypass,

 -  Inner diameter of the failing bioprosthetic aortic valve (homograft or stented or
 stentless heterograft) of ³ 19mm and < 26mm as determined by Doppler echocardiography,

 -  Signed informed consent form.

 Exclusion Criteria:

 -  Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine and
 clopidogrel, Nitinol, or sensitivity to contrast media which cannot be pre-medicated,

 -  Active infection or endocarditis,

 -  Any intra left ventricular mass, thrombus or vegetation evidenced by Doppler
 echocardiography,

 -  Mitral or tricuspid valvular insufficiency ³ grade 2+,

 -  Prosthetic mitral or tricuspid valve,

 -  Femoral and/or iliac and/or aortic vascular condition (stenosis, occlusion or
 tortuosity) that could complicate endovascular access to the aortic valve
 bioprosthesis,

 -  Symptomatic carotid or vertebral artery narrowing (> 70%) disease,

 -  Aortic abdominal or thoracic aneurysm,

 -  Bleeding diathesis or coagulopathy, or patient refuses blood transfusion,

 -  Active peptic ulcer or has had upper gastrointestinal bleeding within the past 3
 months before baseline,

 -  Moribund status or cachexia with short life-expectancy independent of cardiac
 condition,

 -  Any acute neurological event or dysfunction occurred in the past 6 weeks before
 baseline or patient with severe senile dementia,

 -  Therapeutic invasive cardiac procedure, other than balloon aortic valvuloplasty,
 performed within 30 days prior to study procedure or to be performed during or within
 30 days after the study procedure,

 -  Currently, enrolled in this study or another investigational drug or device study.