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

NCT01445171 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 295

Last updated 2023-09-01

Study results available
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Summary

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

Conditions

  • Aortic Valve Stenosis With Insufficiency
  • Aortic Valve Stenosis

Interventions

DEVICE

Aortic Valve Replacement with EDWARDS INTUITY Valve System

Aortic Valve bioprosthesis

Sponsors & Collaborators

  • Edwards Lifesciences

    lead INDUSTRY

Principal Investigators

  • Prof Axel Haverich · MHH Hannover

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2017-12-31
Completion
2017-12-31
FDA Device
Yes

Countries

  • Austria
  • 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 NCT01445171 on ClinicalTrials.gov