Assessing standard oF care and clinical Outcomes UsiNg the EDWARDS INTUITY VAlve SysTem in a European multI-center, active, pOst-market surveillaNce study.

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.

With increasing patient comorbidity and age, there is a tendency toward
biological valve implants avoiding long-term anticoagulation.
Although conventional aortic valve replacement surgery is mostly performed via
a full sternotomy surgical approach, minimally invasive aortic valve surgery,
since its introduction in 1996, has been gaining acceptance. Several studies
have demonstrated reductions in hospital stay, duration of ventilatory support,
incisional pain, blood loss and need for blood transfusions in patients
undergoing minimally invasive AVR procedures.

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.

The objectives of this study are to evaluate cardiac performance
characteristics and adverse events rates associated with the EDWARDS INTUITY
Valve in patients undergoing aortic valve replacement (AVR). The AVR surgical
approach is either full or partial sternotomy or through a right anterior
thoracotomy.

The design of this proposed active post-market study is a prospective, single
arm, multicenter study.

Not Applicable.

The potential risks for the study are the same as those for patients undergoing
conventional AVR surgery. Key risks are listed below. As with all cardiac
surgeries, serious complications, which can lead to death, may be associated
with the procedure or use of the products, such as bioprosthetic heart valves
and the heart valve replacement procedure. In addition, complications due to
individual patient reaction to an implanted device, or to physical or chemical
changes in the components, particularly those of biological origin, may occur
at varying intervals (hours or days) necessitating reoperation and replacement
of the prosthetic device. Risks associated with the use of the devices
applicable in the study can be found in the specific products instructions for
use (IFU).

Some of the potential risks related to participation in this study are listed
below in two categories:
• Risks associated with the surgical aortic valve replacement procedure
• Risks associated with the EDWARDS INTUITY Valve System

Risks associated with surgical replacement of the aortic valve may include but
are not limited to the following:
• Allergic reaction
• Anticoagulant related bleeding
• Annular Dissection
• Aortic Dissection
• Arterial Dissection
• Bacteremia
• Bleeding
• Cardiac Arrest
• Cardiogenic Shock
• Deep Vein Thrombosis (DVT)
• Disseminated Intravascular Coagulation (DIC)
• Esophageal rupture
• Heart Failure
• Hemolysis
• Hypotension
• Hypertension
• Infection, local or systemic
• Heparin Induced Thrombocytopenia (HITs)
• Hematoma
• Myocardial Infarction
• Pericardial Effusion
• Pericardial Tamponade
• Peripheral Embolic Event
• Perforation of free myocardial wall
• Pulmonary Embolism
• Pleural effusion
• Procedural bleeding
• Post-procedural bleeding
• Pneumonia
• Sepsis/Septicemia
• Sternal Wound Infection
• Stroke
• Transient Ischemic Attack (TIA)
• Vascular Access Site Complications

In addition to the above, the following are potential risks that could be
uniquely associated with the EDWARDS INTUITY Valve System:
• Trauma to the mitral chordae resulting from the delivery system
• Frame damage or under-flaring resulting in a reduction of effective orifice
area
• Loss of frame structural integrity resulting in damage to aortic wall or
aortic annulus
• Frame expansion resulting in conduction interruptions or disturbances (i.e.
arrhythmia)
• Frame expansion resulting in mitral valve impingement or abrasion with or
without mitral regurgitation
• Insufficient frame expansion resulting in perivalvular leak requiring

Some or all of these risks may require reoperation, valve explantation, or may
lead to permanent disability or death. All events related to the study medical
procedure or the valve and any post-operative cardiac related events will be
collected and reviewed throughout the study duration and follow-up period.
Investigators will be notified of any additional risks identified during the
study that could affect the health, safety or welfare of the subjects in the
investigation.