EDWARDS INTUITY Valve System CADENCE Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2016-04-30

Brief Summary

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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.

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Detailed Description

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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 ≥ 6 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.

Conditions

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Aortic Valve Disease Aortic Stenosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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EDWARDS INTUITY

EDWARDS INTUITY Valve System, Model 8300A

Group Type ACTIVE_COMPARATOR

EDWARDS INTUITY

Intervention Type DEVICE

To evaluate cardiac performance characteristics and adverse events rates associated with the EDWARDS INTUITY Valve in patients undergoing AVR \& CABG.

Stented aortic bioprostheses

Group Type ACTIVE_COMPARATOR

Stented aortic bioprostheses

Intervention Type DEVICE

In comparison to control valves available on the market.

Interventions

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EDWARDS INTUITY

To evaluate cardiac performance characteristics and adverse events rates associated with the EDWARDS INTUITY Valve in patients undergoing AVR \& CABG.

Intervention Type DEVICE

Stented aortic bioprostheses

In comparison to control valves available on the market.

Intervention Type DEVICE

Other Intervention Names

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aortic stenosis stenosis-based insufficiency aortic valve replacement aortic stenosis stenosis-based insufficiency aortic valve replacement

Eligibility Criteria

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Inclusion Criteria

* ≥18 years of age
* aortic stenosis / mixed aortic stenosis and aortic insufficiency
* SAVR+CABG (1-4 distal anastomoses)
* Log. EuroSCORE ≥6
* NYHA Class ≥II

Exclusion (i.a.):

* pure aortic insufficiency
* pre-existing prosthetic heart valve or ring
* congenital true bicuspid / unicuspid aortic valve
* LVEF \<20%

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No