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A Registry to Evaluate the Direct Flow Medical Transcatheter Aortic Valve System

NCT01845285 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2016-02-24

No results posted yet for this study

Summary

The purpose of this postmarket Registry is to assess the standard of care and clinical outcomes of the Direct Flow Medical Transcatheter Aortic Valve System used in clinical routine according to the approved commercial indications. Procedures and assessments required by this registry are generally considered standard of care for Transcatheter Aortic Valve Replacement patients.

Evaluation criteria will be the incidence of mortality/morbidity and adverse events clinical performance, and hemodynamic performance of the DEVICE via ultrasound (echo) and angiographic imaging.

Conditions

  • Aortic Valve Stenosis

Interventions

DEVICE

Aortic Valve Replacement

Transthoracic Echo (TTE),CT Scan (ECG triggered, contrast enhanced),Aorto-Iliac Angiogram,Peripheral Evaluation,Coronary Evaluation,12 lead ECG,Arrhythmia Assessment, New York Heart Association (NYHA) functional status, Modified Rankin Score Assessment (mRS) if symptomatic for stroke, Current Cardiac Medications, Transthoracic echo (TTE)

Sponsors & Collaborators

  • Direct Flow Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Christopher Naber, MD · Elisabeth Krankenhaus Essen GmbH

Eligibility

Min Age
71 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2016-12-31
Completion
2019-12-31

Countries

  • Germany
  • Italy

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 NCT01845285 on ClinicalTrials.gov