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TRANscatheter or SurgIcal Aortic Valve ReplacemenT in All-Comers With Severe Aortic Valve Stenosis

2016-07-21 02:23:21 | BioPortfolio

Summary

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Aortic Valve Stenosis

Intervention

SAPIEN 3, SAVR

Location

Asan Medical Center
Seoul
Songpa-gu
Korea, Republic of
138-736

Status

Not yet recruiting

Source

Asan Medical Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-07-21T02:23:21-0400

Clinical Trials [934 Associated Clinical Trials listed on BioPortfolio]

The Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis

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 Trial of TAVI vs. SAVR in Patients With Severe Aortic Valve Stenosis at Intermediate Risk of Mortality

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 ...

Safety and Efficacy of the Symetis ACURATE Neo/TF Compared to the Edwards SAPIEN 3 Bioprosthesis.

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...

The SAPIEN 3 Ultra System in Intermediate Risk Patients With Symptomatic Severe Aortic Stenosis

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...

Comparison of Transcatheter Versus Surgical Aortic Valve Replacement in Younger Low Surgical Risk Patients With Severe Aortic Stenosis

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...

PubMed Articles [2009 Associated PubMed Articles listed on BioPortfolio]

Transfemoral aortic valve implantation is more successful with the Edwards Sapien 3 compared with the Edwards XT for the treatment of symptomatic severe aortic stenosis.

Residual aortic regurgitation (AR) after transfemoral aortic valve implantation (TAVI) is associated with increased mortality. The new Edwards Sapien 3 valve (ES3) is designed to reduce paravalvular A...

Treatment of a degenerated sutureless Sorin Perceval® valve using an Edwards SAPIEN 3.

Valve-in-valve implantation is an alternative to reoperation for patients with degenerated bioprostheses. This case report presents a 75-year-old woman presenting with worsening dyspnoea according New...

Outcomes in 937 Intermediate-Risk Patients Undergoing Surgical Aortic Valve Replacement in PARTNER 2A.

The PARTNER-2A randomized trial compared outcomes of transfemoral transcatheter (TAVR) and surgical aortic valve replacement (SAVR) in intermediate-risk patients with severe aortic stenosis. The purpo...

Comparative study of bicuspid vs. tricuspid aortic valve stenosis.

To examine differences and similarities in bicuspid aortic valve (BAV) and tricuspid aortic valve (TAV) stenosis occurring during the same age and whether any differences impact outcomes following aor...

Transcatheter or surgical aortic valve replacement in patients with advanced kidney disease: A propensity score-matched analysis.

Transcatheter aortic valve replacement (TAVR) is an alternative for surgically inoperable patients with severe aortic stenosis. Advanced kidney disease may significantly affect outcomes in patients tr...

Medical and Biotech [MESH] Definitions

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.

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