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Edwards Lifesciences CardiAQ™ Transcatheter Mitral Valve Replacement (TMVR) Early Feasibility Study

2016-03-25 06:53:24 | BioPortfolio

Summary

Early feasibility study to evaluate the safety and function of the Edwards Lifesciences CardiAQ™ Transcatheter Mitral Valve

Description

The study is a multi-center, prospective, single-arm, and non-randomized study designed to evaluate the safety and function of the Edwards Lifesciences CardiAQ™ Transcatheter Mitral Valve with the Transfemoral and Transapical Delivery Systems.

Study Design

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

Conditions

Mitral Valve Regurgitation (Degenerative or Functional)

Intervention

Transcatheter Mitral Valve Replacement (TMVR)

Location

Cedars-Sinai Medical Center
Los Angeles
California
United States
90048

Status

Recruiting

Source

Edwards Lifesciences

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-03-25T06:53:24-0400

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Medical and Biotech [MESH] Definitions

Backflow of blood from the LEFT VENTRICLE into the LEFT ATRIUM due to imperfect closure of the MITRAL VALVE. This can lead to mitral valve regurgitation.

A type of heart valve surgery that involves the repair, replacement, or reconstruction of the annulus of the MITRAL VALVE. It includes shortening the circumference of the annulus to improve valve closing capacity and reinforcing the annulus as a step in more complex valve repairs.

Abnormal protrusion or billowing of one or both of the leaflets of MITRAL VALVE into the LEFT ATRIUM during SYSTOLE. This allows the backflow of blood into left atrium leading to MITRAL VALVE INSUFFICIENCY; SYSTOLIC MURMURS; or CARDIAC ARRHYTHMIA.

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.

Narrowing of the passage through the MITRAL VALVE due to FIBROSIS, and CALCINOSIS in the leaflets and chordal areas. This elevates the left atrial pressure which, in turn, raises pulmonary venous and capillary pressure leading to bouts of DYSPNEA and TACHYCARDIA during physical exertion. RHEUMATIC FEVER is its primary cause.

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