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

2016-03-31 09:53:24 | BioPortfolio

Summary

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

Description

The study is a multi-center, prospective, single-arm, and non-randomized study designed to evaluate the safety and performance of the CardiAQ-Edwards™ Transcatheter Mitral Valve with transapical and transseptal delivery systems in patients with degenerative or functional/ischemic mitral regurgitation.

Study Design

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

Conditions

Mitral Valve Regurgitation

Intervention

Transcatheter Mitral Valve Re-placement (TMVR) with the CardiAQ-Edwards™ Transcatheter Mitral Valve

Location

St. Paul's Hospital, University of British Columbia
Vancouver
British Columbia
Canada
V6Z 1Y6

Status

Not yet recruiting

Source

Edwards Lifesciences

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-03-31T09:53:24-0400

Clinical Trials [975 Associated Clinical Trials listed on BioPortfolio]

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

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

NHLBI DIR LAMPOON Study: Intentional Laceration of the Anterior Mitral Leaflet to Prevent Left Ventricular Outflow Tract Obstruction During Transcatheter Mitral Valve Implantation

Transcatheter mitral valve replacement (TMVR) is an option to treat mitral valve failure when no surgical options exist. In as many as half of patients, TMVR can cause life-threatening blo...

Caisson Transcatheter Mitral Valve Replacement (TMVR)

The purpose of this study is to assess the safety and performance of Transcatheter Mitral Valve Replacement (TMVR) system for the treatment of severe, symptomatic mitral regurgitation (MR)...

PARTNER 3 Trial - Mitral Valve in Valve

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.

Coronary and Structural Interventions Ulm - Transcatheter Mitral Valve Repair (CSI-Ulm-TMVR)

To evaluate the long-term results after transcatheter mitral valve repair

PubMed Articles [1763 Associated PubMed Articles listed on BioPortfolio]

Simultaneous transfemoral transcatheter aortic valve replacement and trans-septal mitral valve-in-ring implantation after partial laceration of an Alfieri stitch.

In patients with an Alfieri Stitch transcatheter mitral valve replacement (TMVR) may be difficult due to the double orifice configuration of the mitral valve. We report a case of simultaneous and comp...

Transcatheter Mitral Valve Planning and the Neo-LVOT: Utilization of Virtual Simulation Models and 3D Printing.

Transcatheter mitral valve replacement (TMVR) is an emerging alternative for patients with severe mitral valve regurgitation who are considered at high risk for conventional surgical options. The earl...

Association of Transcatheter Mitral Valve Repair With Quality of Life Outcomes at 30 Days and 1 Year: Analysis of the Transcatheter Valve Therapy Registry.

Improvements in symptoms, functional capacity, and quality of life are among the key goals of edge-to-edge transcatheter mitral valve repair (TMVR) for mitral regurgitation.

Complexities of transcatheter mitral valve replacement (TMVR) and why it is not transcatheter aortic valve replacement (TAVR).

Transcatheter mitral valve replacement (TMVR) is currently being investigated as a procedural alternative to surgical mitral valve repair or replacement (SMVR). Early data from first-in-man trials wit...

Early experience of TIARA transcatheter mitral valve replacement system.

Mitral regurgitation (MR) is a common valvular disorder that can result in congestive heart failure and cardiovascular death. Patient suffering from this condition are frequently not referred and thus...

Medical and Biotech [MESH] Definitions

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.

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.

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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