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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04310046 -
Optimal Timing of Transcatheter Aortic Valve Implantation and Percutaneous Coronary Intervention - The TAVI PCI Trial
|
N/A | |
| Completed |
NCT03332745 -
Mechanism of Decompensation Evaluation - Aortic Stenosis
|
||
| Recruiting |
NCT06008080 -
Post-Market Clinical Follow Up Study With Navitor Valve
|
||
| Recruiting |
NCT06055751 -
Long Term Evaluation of Cardiac Arrhythmias After Transcatheter Aortic Valve Implantation -The LOCATE Registry
|
||
| Active, not recruiting |
NCT04815785 -
Safety and Efficacy of TaurusOne® Transcatheter Aortic Valve System in Patients With Severe Calcific Aortic Stenosis
|
N/A | |
| Terminated |
NCT02202434 -
Safety and Efficacy Study of Lotus Valve for Transcatheter Aortic Valve Replacement
|
N/A | |
| Recruiting |
NCT03029026 -
The Role of Occult Cardiac Amyloid in the Elderly With Aortic Stenosis.
|
||
| Active, not recruiting |
NCT02903420 -
A Clinical Trial of Transcatheter Aortic Valves in Dialysis Patients (Japan)
|
N/A | |
| Completed |
NCT02629328 -
CardioCel Tri-leaflet Repair Study
|
N/A | |
| Completed |
NCT02306226 -
Symetis ACURATE Neo™ Valve Implantation SAVI TF Registry
|
||
| Withdrawn |
NCT01648309 -
Neuropsychological Testing in Patients Undergoing Transvascular Aortic Valve Implantation
|
N/A | |
| Completed |
NCT01676727 -
ADVANCE Direct Aortic Study
|
||
| Completed |
NCT01422044 -
Risk Prediction in Aortic Stenosis
|
N/A | |
| Withdrawn |
NCT00774657 -
Ventricular Remodeling In Patients With Aortic Stenosis Assessed Echocardiography
|
N/A | |
| Terminated |
NCT00535899 -
Speckle Tracking Imaging in Patients With Low Ejection Fraction Aortic Stenosis (SPArKLE-AS)
|
N/A | |
| Terminated |
NCT05070130 -
OpSens PRIME CLASS
|
||
| Completed |
NCT03314857 -
China XT: Safety and Effectiveness of Edwards Lifesciences SAPIEN XT THV in the Chinese Population
|
N/A | |
| Completed |
NCT04157920 -
Impact of Predilatation Between Self-expanding Valves
|
N/A | |
| Enrolling by invitation |
NCT06212050 -
Feasibility, Safety, and Effectiveness of the ACURATE neo2 Transcatheter Heart Valve for Severe Bicuspid Aortic Stenosis
|
||
| Recruiting |
NCT05893082 -
Multicenter Feasibility Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
|
N/A |