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TranScatheter Aortic Valve RepLacement System US Feasibility Trial

NCT01932099 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2016-10-31

No results posted yet for this study

Summary

A study to assess the safety and effectiveness of the Direct Flow Medical aortic valve system. This is for people with severe aortic stenosis who are not well enough to undergo a surgical repair. The delivery of this device is done via the femoral artery.

Conditions

  • Aortic Valve Stenosis

Interventions

DEVICE

Transcatheter aortic valve replacement

Direct Flow Medical Transcatheter Aortic Valve System is indicated for use in aortic stenosis for patients at extreme surgical risk for aortic valve replacement.

Sponsors & Collaborators

  • Direct Flow Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • E. Murat Tuzcu, MD · The Cleveland Clinic

  • Patrick M McCarthy, MD · Northwestern Memorial Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2014-06-30
Completion
2018-12-31

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 NCT01932099 on ClinicalTrials.gov