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CoreValve Advance International Post Market Study

2014-08-27 03:15:41 | BioPortfolio

Summary

The CoreValve Advance study is intended to evaluate the clinical utility of the Medtronic CoreValve System in a "Real-World" patient population.

Description

The CoreValve Advance study is intended to evaluate the clinical utility of the Medtronic CoreValve System for percutaneous aortic valve implantation in a "Real-World" patient population with severe aortic valve stenosis. Data collected in this study will provide additional information on the understanding of the safety and device performance and how to best treat elderly patients with severe aortic valve stenosis. In addition, health economic data will be collected to understand the improvement of quality of life and the cost effectiveness of the therapy.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Conditions

Severe Aortic Valve Stenosis

Intervention

Medtronic CoreValve System

Location

Univesitätsklinik Graz
Graz
Austria
8036

Status

Recruiting

Source

Medtronic Bakken Research Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:41-0400

Clinical Trials [1429 Associated Clinical Trials listed on BioPortfolio]

CoreValve® System Australia/New Zealand Clinical Study

To evaluate the performance, efficacy and safety of the percutaneous implantation of the CoreValve® prosthetic aortic valve in patients with severe symptomatic native aortic valve stenosi...

Safety and Efficacy Continued Access Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in Very High Risk Subjects and High Risk Subjects Who Need Aortic Valve Replacement

The purpose of the study is to evaluate the safety and efficacy of the Medtronic CoreValve® System in the treatment of symptomatic severe aortic stenosis in subjects who have a predicted ...

Medtronic CoreValve Evolut R U.S. Clinical Study (Evolut 34R Addendum)

The study objectives are to assess the safety and efficacy of the CoreValve Evolut 34R transcatheter aortic valve replacement (TAVR) system in patients with severe symptomatic aortic steno...

Clinical Evaluation of Percutaneous Implantation of the Medtronic CoreValve Aortic Valve Prosthesis (18Fr-Study)

The investigation concerns a prospective, multicenter, single arm safety and performance study evaluating the Medtronic CoreValve system. Approximately 120 patients presenting with symptom...

CoreValve™ Evolut R™ FORWARD Study

Prospective, single arm, multi-center, observational, post market study to document the clinical and device performance outcomes of the Evolut R system used in routine hospital practice in...

PubMed Articles [14141 Associated PubMed Articles listed on BioPortfolio]

Valve-in-valve transcatheter aortic valve implantation with CoreValve/Evolut Rfor degenerated small versus bigger bioprostheses.

We present our single center experience with Medtronic CoreValve and Evolut R regarding procedural outcome and 3 years follow-up in patients with degenerated bioprostheses.

Evolut R implantation via the brachial artery.

Transfemoral transcatheter aortic valve implantation is an established therapy to treat elderly patients affected by severe aortic stenosis, who are considered to be at high or extreme risk for surgic...

Transcatheter aortic valve implantation with the 34 mm self-expanding CoreValve Evolut R: initial experience in 101 patients from a multicenter registry.

The recently released Medtronic CoreValve Evolut R® 34 mm is the largest ever developed self-expanding transcatheter heart valve. Clinical data of this device size are scarce.

Transcatheter aortic valve replacement in women.

This review examines the treatment options for women with severe aortic stenosis. It is known that female sex is associated with poorer outcomes after surgical aortic valve replacement. With the intro...

Transcaval Valve-in-Valve-in-Valve Aortic Valve Replacement for Bioprosthetic Valve Degeneration.

A 74-year-old man presented with progressive dyspnea on exertion. History included peripheral arterial disease and coronary artery bypass grafting with aortic valve replacement 12 years ago. Subsequen...

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.

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.

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.

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.

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