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Multi Modal Cardiac Imaging Prior Transcatheter Aortic Valve Implantation

NCT01805739 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 5000

Last updated 2020-10-30

No results posted yet for this study

Summary

Transcatheter aortic valve implantation (TAVI) is an emerging alternative therapy for aortic stenosis for patients ineligible for open heart surgery or at high risk for perioperative complications. Pre-procedural imaging of the aortic root is essential for selection of the correct valve prosthesis and to minimize complications as prosthesis mismatch, possibly subsequent embolization, coronary obstruction, annulus rupture or severe aortic regurgitation.

The aim of the study is to compare the different imaging modalities for aortic root measurements.

Aortic root imaging will be performed prior to TAVI-procedure. The contrast injection will be performed either into the aorta or into the left ventricle. The datasets will be assessed by blinded-independent observers in a multi-planar reconstruction view.

The study will be performed retrospectively (2009-2012) and prospectively starting 2013.

Conditions

  • Aortic Valve Stenosis

Sponsors & Collaborators

  • Klinik für Kardiologie, Pneumologie und Angiologie

    lead OTHER

Principal Investigators

  • Malte Kelm, MD · Division of Cardiology, Pulmonary Diseases, Vascular Medicine, University Hospital Duesseldorf

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2030-12-31
Completion
2030-12-31

Countries

  • 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 NCT01805739 on ClinicalTrials.gov