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REPRISE EDGE 29 mm EU Study

2016-11-17 11:38:21 | BioPortfolio

Summary

The objective of the REPRISE EDGE 29 mm EU study is to evaluate performance and safety of the 29 mm LOTUS Edge™ Valve System for transcatheter aortic valve replacement (TAVR) in symptomatic subjects with calcific, severe native aortic stenosis who are considered at extreme or high risk for surgical aortic valve replacement (SAVR).

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Aortic Valve Stenosis

Intervention

29 mm LOTUS Edge™ Valve System

Status

Not yet recruiting

Source

Boston Scientific Corporation

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-11-17T11:38:21-0500

Clinical Trials [1351 Associated Clinical Trials listed on BioPortfolio]

REpositionable Percutaneous Replacement of NatIve StEnotic Aortic Valve Through Implantation of LOTUS EDGE Valve System

The objective of the REPRISE EDGE study is to confirm the acute performance and safety of the LOTUS Edge™ Valve System when used with the Lotus™ or iSleeve™ Introducer Set for transc...

Performance and Safety of the Lotus™ Valve With a FLEXible Delivery System

To confirm the acute performance and safety of the Lotus™ Valve Flex System for transcatheter aortic valve replacement (TAVR) in symptomatic patients with severe calcific aortic stenosis...

Safety and Efficacy of Lotus Valve For TAVI In Patients With Severe Aortic Stenosis In Chinese Population

To confirm the safety and efficacy of the Lotus™ Valve System in the Chinese population for Transcatheter Aortic Valve Implantation (TAVI) in symptomatic patients with severe aortic sten...

Transfemoral Replacement of Aortic Valve With HLT MeriDIAN Valve Feasibility Trial CANADA

To evaluate the safety and performance of the HLT System in patients with severe aortic stenosis who present at high risk for aortic valve replacement surgery.

5 Year Observation of Patients With PORTICO Valves

Further assess the performance and safety profile of the commercially available Portico Valve implanted, using the Delivery System and the Loading System, in patients with severe symptomat...

PubMed Articles [10548 Associated PubMed Articles listed on BioPortfolio]

Aortic Valve-in-Valve in Externally Mounted Bioprosthesis: A Safe Treatment Option for Bioprosthetic Structural Valve Dysfunction.

Aortic valve-in-valve implantation for prosthetic valve dysfunction is a good alternative to reoperative valve replacement. There are some limitations to this approach including the risk of coronary o...

Diagnosis and Outcomes of Transcatheter Aortic Valve Implantation in Bicuspid Aortic Valve Stenosis.

Bicuspid aortic valve is the most common congenital cardiac malformation. Aortic valve replacement is often required in older patients but the surgical risk is often extremely high. As Transcatheter a...

Development and Results of Transcatheter and Surgical Aortic Valve Replacement in Germany 2014 and 2015.

 Treatment of aortic valve stenosis has been changing since the introduction of transcatheter aortic valve replacement (TAVR). The present study investigates the treatment of aortic valve stenosis i...

Diagnosis and treatment of aortic valve stenosis.

Aortic valve stenosis (AS) is the most frequently observed valvular heart disease. Once it is symptomatic the mortality rapidly increases. The diagnostic gold standard is transthoracic echocardiograph...

Meta-analysis of Valve-in-Valve Transcatheter versus Redo Surgical Aortic Valve Replacement.

 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...

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.

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.

The pathologic narrowing of the orifice of the TRICUSPID VALVE. This hinders the emptying of RIGHT ATRIUM leading to elevated right atrial pressure and systemic venous congestion. Tricuspid valve stenosis is almost always due to RHEUMATIC FEVER.

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Surgical treatments
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...


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