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Pilot Trial: Comparison of Flow Patterns

NCT02288871 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2018-03-27

No results posted yet for this study

Summary

The purpose of this study is to determine why sutureless aortic bioprostheses apparently offer better haemodynamic properties compared to sewed-in aortic bioprostheses in patients who underwent aortic valve replacement.

Our approach to address this question is the combination of clinical data with the application of specifically validated experimental and computer based analyses to compare the performance of these valves under patient-specific conditions.

Conditions

  • Aortic Valve Stenosis
  • Aortic Valve Insufficiency

Interventions

RADIATION

Cardiac CT-scan

ECG gated CT angiography of the heart will be performed on a 128-slice dual-source and two Stellar detectors CT system with retrospective ECG-gating (Siemens/SOMATOM Definition Flash - Siemens, Germany, 100kV, 395.75 mAs). In details, multi-phase images will be acquired to reconstruct between 10 and 100% of the cardiac cycle (10% increments) with a slice thickness of 1 mm. Examination will include left ventricular outflow tract, aortic root, coronary sinus, ascending aorta together with the prosthetic valves.

Sponsors & Collaborators

  • University College, London

    collaborator OTHER

  • Medical University of Vienna

    lead OTHER

Principal Investigators

  • Alfred Kocher, MD · Division of Cardiac Surgery, Department of Surgery, Medical University of Vienna

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2020-12-31
Completion
2021-12-31

Countries

  • Austria

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 NCT02288871 on ClinicalTrials.gov