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EDWARDS INTUITY Valve System CADENCE Study

2016-02-23 23:38:24 | BioPortfolio

Summary

The study purpose is to compare the EDWARDS INTUITY valve system with commercially available stented aortic bioprostheses, in patients requiring aortic valve replacement surgery with coronary artery bypass.

Description

This is a randomized study comparing the cross-clamp time (XCT) and cardiopulmonary bypass time (CPBT) of the EDWARDS INTUITY valve system with any commercially available stented aortic bioprosthesis, in patients with logistic EuroSCORE 1 ≥ 8 undergoing elective surgical aortic valve replacement surgery with concomitant coronary bypass grafts.

Additionally, the aim is to gather sufficient data to quantify the effect size of short term patient benefit outcomes previously identified from literature and finally to explore additional healthcare resource utilization or health economic endpoints.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Aortic Valve Disease

Intervention

EDWARDS INTUITY, Stented aortic bioprostheses

Location

CHU Bordeaux, Hôpital Haut-Lévêque
Pessac
France
33604

Status

Active, not recruiting

Source

Edwards Lifesciences

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-02-23T23:38:24-0500

Clinical Trials [1145 Associated Clinical Trials listed on BioPortfolio]

EDWARDS INTUITY Valve System CADENCE-MIS Study

The study purpose is to compare the EDWARDS INTUITY valve system in a minimal invasive surgical approach (MIS) with any commercially available aortic bioprosthesis in standard full ster-no...

Surgical Treatment of Aortic Stenosis With a Next Generation Surgical Aortic Valve

The purpose of this clinical investigation is to confirm that the safety and performance of the EDWARDS INTUITY Valve System.

ProspeCtive, nOn-randoMized, MulticENter Clinical Evaluation of Edwards Pericardial Bioprostheses With a New Tissue Treatment Platform

The objective of this trial is to confirm that the modifications to tissue processing, valve sterilization and packaging do not raise any new questions of safety and effectiveness in subje...

EDWARDS INTUITY Elite Valve System

The purpose of this active post-market surveillance study is to confirm that EDWARDS INTUITY Elite reduces cross clamp time (XCT) in MIS setting when compared to published data with a conv...

Comparison of Two Pericardial Bioprostheses in AVR

The purpose of the study is to compare early and 1-year hemodynamic performance and clinical outcomes after aortic valve replacement using two pericardial bioprosthesis, Avalus and Carpent...

PubMed Articles [16243 Associated PubMed Articles listed on BioPortfolio]

Late onset valve dislocation of the Edwards Intuity rapid-deployment bioprosthesis.

Over the last decade, aortic valve replacement with rapid-deployment biological bioprosthesis has become a common alternative technique to mechanical or biological stented valves for high-risk patient...

Severe structural deterioration of small aortic bioprostheses treated with valve-in-valve transcatheter aortic valve implantation.

The aim of this study was to evaluate outcomes of valve-in-valve transcatheter aortic valve implantation (VIV-TAVI) in patients with degenerated small bioprostheses.

Sutureless versus Stented Bioprostheses for Aortic Valve Replacement: The Randomized PERSIST-AVR Study Design.

 Sutureless biological valves for surgical aortic valve replacement (SAVR), characterized by the absence of anchoring sutures at the aortic annulus, are gaining popularity because of ease and reprod...

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...

Biomarkers of aortic bioprosthetic valve structural degeneration.

Bioprosthetic valves are now used for the majority of surgical aortic valve replacements and for all transcatheter aortic valve replacements. However, bioprostheses are subject to structural valve det...

Medical and Biotech [MESH] Definitions

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.

Pathological condition characterized by the backflow of blood from the ASCENDING AORTA back into the LEFT VENTRICLE, leading to regurgitation. It is caused by diseases of the AORTIC VALVE or its surrounding tissue (aortic root).

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.

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.

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