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EDWARDS INTUITY Valve System CADENCE-MIS Study

NCT02672553 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2019-01-28

Study results available
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Summary

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 sternotomy surgical approach.

Conditions

  • Aortic Valve Disease
  • Aortic Stenosis

Interventions

DEVICE

EDWARDS INTUITY Valve System, Model 8300A

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

DEVICE

Stented Aortic Bioprostheses

In comparison to control valves available on the market undergoing FS-AVR

Sponsors & Collaborators

  • Edwards Lifesciences

    lead INDUSTRY

Principal Investigators

  • Prof. Borger, MD · Leipzig Heart Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2015-03-31
Completion
2015-08-31

Countries

  • Germany

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 NCT02672553 on ClinicalTrials.gov