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Not listed Phase 2 Interventional

TranScatheter Aortic Valve RepLacement System US Feasibility Trial

ClinicalTrials.gov ID: NCT01932099

Public ClinicalTrials.gov record NCT01932099. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 29, 2026, 11:59 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

The Direct Flow Medical TranScatheter Aortic Valve RepLacement System US Feasibility Trial

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01932099
Recruitment status
Not listed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Direct Flow Medical, Inc.
Industry
Enrollment
30 participants

Conditions and interventions

Eligibility (public fields only)

Age range
Not listed
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 2013 (Type not available)
Primary completion
Jun 2014 (Actual)
Completion
Dec 2018 (Estimated)
Last update posted
Oct 31, 2016

2013 – 2018

United States locations

U.S. sites
6
U.S. states
6
U.S. cities
6
Facility City State ZIP Site status
UC Davis Medical Center Sacramento California 95817 —
Northwestern Memorial Hospital Chicago Illinois 60611 —
Henry Ford Hospital Detroit Michigan 48202 —
Washington University Hospital St Louis Missouri 63110 —
Columbia Univ. Medical Center New York New York 10032 —
Cleveland CLinic Cleveland Ohio 44195 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01932099, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 31, 2016 · Synced Oct 29, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01932099 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →