Aortic Stenosis Clinical Trial
Official title:
Assessing Standard oF Care and Clinical Outcomes UsiNg the EDWARDS INTUITY VAlve SysTem in a European multI-center, Active, pOst-market surveillaNce Study.
The purpose of this active post-market surveillance study is to confirm the safety and
effectiveness of the EDWARDS INTUITY Valve System in the study population.
The objective is to evaluate cardiac performance characteristics and adverse events rates
associated with the EDWARDS INTUITY Valve in patients undergoing AVR. The AVR surgical
approach is either full or partial sternotomy or a right anterior thoracotomy.
Aortic valve replacement with mechanical or biological heart valves is the treatment of
choice for aortic valve stenosis. Over the past several years, life expectancy has increased
in industrial nations, but this has been accompanied by a rising rate of elderly patients
with multiple illnesses.
Aortic stenosis remains the most common cause of adult valvular heart disease, the prevalence
increasing with age. Average survival of patients treated conservatively has historically
been reported as 2—5 years from the onset of symptoms. More recent studies have confirmed the
dismal prognosis of severe aortic stenosis. Advanced age, reduced left ventricular ejection
fraction, congestive heart failure and renal insufficiency appear to be independent
predictors of reduced survival. Asymptomatic patients with very severe aortic stenosis also
share a poor prognosis with a high event rate and a risk of rapid functional deterioration.
Early surgery offers a therapeutic option to improve clinical outcomes via decreasing cardiac
mortality and improving symptoms.
Bioprostheses offer several advantages over mechanical bioprostheses, the most important
being freedom from anticoagulation with a low rate of thromboembolic accidents.
In response to clinical need and in support of advances in minimally invasive surgical
approaches to conventional AVR, Edwards Lifesciences developed the EDWARDS INTUITY Valve
System to achieve clinical benefits by reducing cardiopulmonary bypass and cross clamp times,
while facilitating a less invasive approach to aortic valve replacement.
The system includes the EDWARDS INTUITY Valve System, Model 8300A and the EDWARDS INTUITY
Delivery System, Model 8300D; the valve is based on prior heart valve designs which have a
long history of safety and effectiveness and have incorporated additional features designed
to improve patient outcomes and safety.
With only 3 guiding sutures and secure balloon expandable frame, the EDWARDS INTUITY Valve
system is well suited for smaller incisions and tight access, with an emphasis on procedural
efficiency within existing operating suite of the surgeon.
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