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Surgical Treatment of Aortic Stenosis With a Next Generation, Rapid Deployment Surgical Aortic Valve

NCT01700439 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 934

Last updated 2023-05-19

Study results available
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Summary

The purpose of the clinical study is to prove that the heart valve device is safe, effective, and performs as intended.

Conditions

  • Aortic Valve Stenosis
  • Aortic Valve Stenosis With Insufficiency
  • Regurgitation, Aortic Valve
  • Aortic Valve Incompetence

Interventions

DEVICE

EDWARDS INTUITY valve

Surgical replacement of the aortic valve with the EDWARDS INTUITY valve.

Sponsors & Collaborators

  • Edwards Lifesciences

    lead INDUSTRY

Principal Investigators

  • Glenn Barnhart, MD · Swedish Medical Center

  • Walter Randolph Chitwood, MD · East Carolina University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-26
Primary Completion
2021-05-26
Completion
2021-05-26
FDA Device
Yes

Countries

  • United States

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 NCT01700439 on ClinicalTrials.gov