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

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.

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Key information

Conditions

Aortic Valve Stenosis Aortic Valve Disease Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Age range

75 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alberta Hospital, Edmonton, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,
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 (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:

Femoral, iliac or aortic vascular condition (e.g. stenosis, tortuosity), that make insertion and endovascular access to the aortic valve impossible, or
Symptomatic carotid or vertebral arteries narrowing (> 70%) disease, or
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.

Treatment and study plan

Medtronic CoreValve System

Device

Transcatheter Aortic Valve

Other names: Medtronic CoreValve Trancatheter Aortic Valve, Medtronic CoreValve Percutaneous Aortic Valve

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

Time frame: Was assessed during the procedure and completed once the procedure was conlcluded
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

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Registry information

Official study 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)

Important dates

Study start: 2006
Primary completion: 2009
Study completion: 2013
First posted: Jan 18, 2010
Registry last updated: Feb 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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