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EDWARDS INTUITY Valve System CADENCE Study

NCT02688153 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2018-06-01

Study results available
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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.

Conditions

  • Aortic Valve Disease
  • Aortic Stenosis

Interventions

DEVICE

EDWARDS INTUITY

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

DEVICE

Stented aortic bioprostheses

In comparison to control valves available on the market.

Sponsors & Collaborators

  • Edwards Lifesciences

    lead INDUSTRY

Principal Investigators

  • Prof. Labrousse, MD · CHU Bordeaux - Hôpital Haut-Lévèque

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2016-04-30
Completion
2016-04-30
FDA Device
Yes

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02688153 on ClinicalTrials.gov