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The study purpose is to compare the EDWARDS INTUITY valve system in a minimal invasive surgical approach (MIS) with any commercially available aortic bioprosthesis in standard full ster-notomy surgical approach.
This is a randomized study to compare the cross-clamp time (XCT) and cardiopulmonary bypass time (CPBT) of the EDWARDS INTUITY valve system in a minimally invasive surgical approach (MIS) with any commercially available aortic bioprosthesis in standard full sternotomy surgical approach, in patients with logistic EuroScore < 20 undergoing elective isolated aortic valve replacement (AVR) surgery.
Additionally, the aim is to gather sufficient data to quantify the effect size of short term patient benefit outcomes previously identified from literature and to explore additional healthcare resource utilization endpoints.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Aortic Valve Disease
EDWARDS INTUITY Valve System, Model 8300A, Stented Aortic Bioprostheses
Leipzig Heart Center
Published on BioPortfolio: 2016-02-03T17:53:24-0500
The study purpose is to compare the EDWARDS INTUITY valve system with commercially available stented aortic bioprostheses, in patients requiring aortic valve replacement surgery with coron...
The purpose of this clinical investigation is to confirm that the safety and performance of the EDWARDS INTUITY Valve System.
The purpose of this active post-market surveillance study is to confirm that EDWARDS INTUITY Elite reduces cross clamp time (XCT) in MIS setting when compared to published data with a conv...
To assess the safety and effectiveness of the SAPIEN 3 (Edwards Lifesciences, Irvine, California) transcatheter heart valve in patients with a failing aortic bioprosthetic valve.
This is a prospective, non-randomized, multi-center study designed to evaluate safety and effectiveness of the ATS 3f Enable Aortic Bioprosthesis in a patient population undergoing isolate...
Over the last decade, aortic valve replacement with rapid-deployment biological bioprosthesis has become a common alternative technique to mechanical or biological stented valves for high-risk patient...
We present a simpler and faster way of implanting the Edwards Intuity Elite rapid deployment valve system. Annular sizing and guiding suture placement are performed in the usual manner. After the valv...
Sutureless biological valves for surgical aortic valve replacement (SAVR), characterized by the absence of anchoring sutures at the aortic annulus, are gaining popularity because of ease and reprod...
Spontaneous leaflet fracture of mechanical heart valve prostheses is very rare. We describe a case of spontaneous leaflet embolization 31 years after aortic valve replacement with an Edwards-Duromedic...
The downward displacement of the cuspal or pointed end of the trileaflet AORTIC VALVE causing misalignment of the cusps. Severe valve distortion can cause leakage and allow the backflow of blood from the ASCENDING AORTA back into the LEFT VENTRICLE, leading to aortic regurgitation.
Surgical treatment for severe AORTIC VALVE STENOSIS. Transcatheter aortic valve replacement (TAVR) is used as an alternative option in patients who are deemed at high risk or inoperable for traditional open-heart surgery.
Pathological condition characterized by the backflow of blood from the ASCENDING AORTA back into the LEFT VENTRICLE, leading to regurgitation. It is caused by diseases of the AORTIC VALVE or its surrounding tissue (aortic root).
A type of constriction that is caused by the presence of a fibrous ring (discrete type) below the AORTIC VALVE, anywhere between the aortic valve and the MITRAL VALVE. It is characterized by restricted outflow from the LEFT VENTRICLE into the AORTA.
A pathological constriction that can occur above (supravalvular stenosis), below (subvalvular stenosis), or at the AORTIC VALVE. It is characterized by restricted outflow from the LEFT VENTRICLE into the AORTA.
Surgery is a technology consisting of a physical intervention on tissues. All forms of surgery are considered invasive procedures; so-called "noninvasive surgery" usually refers to an excision that does not penetrate the structure being exci...
Health care (or healthcare) is the diagnosis, treatment, and prevention of disease, illness, injury, and other physical and mental impairments in humans. Health care is delivered by practitioners in medicine, chiropractic, dentistry, nursing, pharmacy, a...