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

Aortic Valve Stenosis Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01051518
• Other study ID #: COR-2006-02
• Status: Completed
• Phase: N/A
• Start date: May 2006
• Est. completion date: June 2013

Study information

• Verified date: February 2019
• Source: Medtronic Cardiovascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: June 2013
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aortic Valve Stenosis

Intervention

Device:
• Medtronic CoreValve System
Transcatheter Aortic Valve

Locations

Country	Name	City	State
Canada	University of Alberta Hospital	Edmonton
Canada	Institut de Cardiologie de Montreal	Montreal
Canada	University of Ottawa Heart Institute	Ottawa
Germany	Herzzentrum Leipzig GmbH	Leipzig
Germany	HELIOS Heart Center Siegburg	Siegburg
Netherlands	Amphia Hospital	Breda
Netherlands	Erasmus MC	Rotterdam
United Kingdom	Glenfield Hospital	Leicester
United Kingdom	Royal Brompton & Harefield NHS Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Bakken Research Center

Countries where clinical trial is conducted

Canada,  Germany,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite Major Adverse Event (MAE) Free Rate	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.	30 (+7) days post procedure
Secondary	Composite Technical Device Success	Composite technical success was defined as the percentage of subjects in whom success on all four technical measures of the "Device Functionality Assessment" was achieved and who were adjudicated as having no device failure or malfunction.; The four measures of the ''Device Functionality Assessment'' were: Load the valve delivery system using the loading system; Access the aortic valve with the delivery catheter; Deploy the valve accurately across the native aortic valve; Remove the intact delivery system	Was assessed during the procedure and completed once the procedure was conlcluded

External Links

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