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)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Aortic Valve Stenosis
- Sponsor
- Medtronic Bakken Research Center
- Enrollment
- 126
- Locations
- 9
- Primary Endpoint
- Composite Major Adverse Event (MAE) Free Rate
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
Investigators
Eligibility 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:
- •Cirrhosis of the liver (Child class A or B),
- •Pulmonary insufficiency : Forced expiratory volume in one second (FEV1) \< 1 liter,
- •Previous cardiac surgery (Coronary artery bypass grafting (CABG), valvular surgery),
- •Pulmonary hypertension \> 60 mmHg and high risk of cardiac surgery other than valve replacement,
- •Porcelain aorta
- •Recurrent pulmonary embolus,
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),
Outcomes
Primary Outcomes
Composite Major Adverse Event (MAE) Free Rate
Time Frame: 30 (+7) days post procedure
Percentage of subjects without a composite major adverse event (MAE) at 30 (+ 7) days post-procedure. MAE included all-cause death, non-fatal myocardial infarction, stroke, emergent cardiac re-intervention, cardiac tamponade, non-structural or structural valve dysfunction, cardiogenic shock, endocarditis, TIA, embolism, aortic dissection, access site vessel dissection, vessel perforation, acute vessel occlusion, major bleeding and major vascular injury.
Secondary Outcomes
- Composite Technical Device Success(Was assessed during the procedure and completed once the procedure was conlcluded)