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PARTNER 3 Trial - Mitral Valve in Valve

2017-06-22 02:53:21 | BioPortfolio

Summary

To assess the safety and effectiveness of the SAPIEN 3 (Edwards Lifesciences, Irvine, California) transcatheter heart valve in patients with a failing mitral bioprosthetic valve.

Description

A prospective, single-arm, multicenter clinical trial. This study will enroll patients with symptomatic heart disease due to a failing bioprosthetic mitral valve (stenosed, insufficient, or combined).

Study Design

Conditions

Mitral Valve Insufficiency

Intervention

Edwards SAPIEN 3 transcatheter valve, Model 9600TFX

Status

Not yet recruiting

Source

Edwards Lifesciences

Results (where available)

View Results

Links

Published on BioPortfolio: 2017-06-22T02:53:21-0400

Clinical Trials [1112 Associated Clinical Trials listed on BioPortfolio]

The PARTNER 3 - AVIV Trial

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.

CardiAQ-Edwards™ Transcatheter Mitral Valve Replacement (TMVR) Study

Clinical study to evaluate the safety and performance of the CardiAQ-Edwards™ Transcatheter Mitral Valve

Surgical Implantation of TRAnscatheter vaLve in Native Mitral Annular Calcification (SITRAL) Study

The purpose of this study is to establish the safety and feasibility of the Edwards SAPIEN 3 valve in subjects with mitral annular calcification (MAC) associated with mitral stenosis (MS) ...

A Clinical Trial of Transcatheter Aortic Valves in Japanese Dialysis Patients

A single arm, prospective, open, non-randomized, Japanese multicenter trial to evaluate the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve System (Model: 9600TF...

Multicenter Trial of Congenital Pulmonic Valve Dysfunction Studying the SAPIEN 3 THV With the Alterra Adaptive Prestent

To demonstrate the safety and functionality of the Edwards Alterra Adaptive Prestent in conjunction with the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) System in patients with a dysf...

PubMed Articles [10012 Associated PubMed Articles listed on BioPortfolio]

Edwards SAPIEN Transcatheter Pulmonary Valve Implantation: Results From a French Registry.

The aim of this study was to describe and analyze data from patients treated in France with the Edwards SAPIEN transcatheter heart valve in the pulmonary position.

Hybrid transcatheter tricuspid valve-in-valve placement of an Edwards Sapien XT valve in palliated hypoplastic left heart syndrome.

Tricuspid regurgitation in the context of hypoplastic left heart syndrome (HLHS) carries a significant burden of both mortality and morbidity. We report successful hybrid trans-atrial implantation of ...

Initial results from the off-label use of the SAPIEN S3 valve for percutaneous transcatheter pulmonary valve replacement: A multi-institutional experience.

To describe a multi-center experience of percutaneous transcatheter pulmonary valve replacement (TPVR) using the Edwards Sapien S3 Valve.

SAPIEN valve for percutaneous transcatheter pulmonary valve replacement without "pre-stenting": A multi-institutional experience.

To describe a multicenter experience of percutaneous transcatheter pulmonary valve replacement (TPVR) using the Edwards SAPIEN S3 valve without the use of a prior stent ("pre-stenting").

Transcarotid Approach for Transcatheter Aortic Valve Replacement With the Sapien 3 Prosthesis: A Multicenter French Registry.

This study sought to describe the procedural and clinical outcomes of patients undergoing transcarotid (TC) transcatheter aortic valve replacement (TAVR) with the Edwards Sapien 3 device.

Medical and Biotech [MESH] Definitions

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.

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.

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.

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.

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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