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The purpose of this study is to determine that Transcatheter aortic valve replacement (TAVR) with SAPIEN 3 is superior to traditional surgical aortic valve replacement(SAVR) with bio-prosthesis regarding the rate of all-cause mortality at 1 year in patients with symptomatic severe aortic valve stenosis with age ≥65 years old.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Aortic Valve Stenosis
SAPIEN 3, SAVR
Asan Medical Center
Korea, Republic of
Not yet recruiting
Asan Medical Center
Published on BioPortfolio: 2016-07-21T02:23:21-0400
To establish the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve in patients with severe, symptomatic aortic stenosis who are at low operative risk for standard ...
Randomized controlled, multi-center trial randomizing patients with symptomatic severe aortic stenosis at intermediate operative risk of mortality, as assessed by the STS-PROM-Score, in a ...
Transcatheter aortic valve implantation (TAVI) is an established treatment option for patients with severe symptomatic aortic stenosis and at increased risk for surgical aortic valve repla...
A Prospective, Single-arm, Study of the Edwards Lifesciences SAPIEN 3 Ultra Delivery System used with the SAPIEN 3 Ultra THV and SAPIEN 3 THV in Intermediate Risk Patients with Severe, Cal...
A randomized clinical trial investigating transcatheter (TAVR) versus surgical (SAVR) aortic valve replacement in patients 75 years of age or younger suffering from severe aortic valve ste...
The aim of this study was to evaluate whether transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 valve (S3-TAVR) results in improved quality of life (QoL) compared with previous-generatio...
Transcatheter aortic valve replacement (TAVR) is now standard of care for patients with symptomatic severe aortic stenosis who are extreme, high or intermediate risk for surgical aortic valve replacem...
The objective of this study was to determine whether valve-in-valve transcatheter aortic valve implantation (VIV-TAVI) is associated with better survival than redo surgical aortic valve replacement...
The aim of this study was to determine factors affecting paravalvular leak (PVL) in transcatheter aortic valve replacement (TAVR) with the Edwards SAPIEN 3 (S3) valve in extremely large annuli.
Symptomatic aortic stenosis has a poor prognosis. Many patients are considered inoperable or at high surgical risk for surgical aortic valve replacement (SAVR), reflecting their age, comorbidities and...
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.
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.
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 occurring in the region above the AORTIC VALVE. It is characterized by restricted outflow from the LEFT VENTRICLE into the AORTA.
A pathological constriction occurring in the region below 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...
Arthroplasty is a surgical procedure to restore the integrity and function of a joint. A joint can be restored by resurfacing the bones. An artificial joint (called a prosthesis) may also be used. Various types of arthritis may affect the joints. Osteo...