CoreValve® System Australia/New Zealand Clinical Study

Covidien

Status: Completed

Conditions: Aortic Valve Stenosis

Treatments: Device: Medtronic CoreValve® System

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT01015612

CV-PAVR-R2007

Details and patient eligibility

About

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

Full description

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

Enrollment: 634 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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634 participants in 1 patient group

Medtronic CoreValve® System Implantation

Experimental group

Description:

Patients with symptomatic severe aortic stenosis who have an elevated surgical risk

Treatment:

Device: Medtronic CoreValve® System