Clinical Trial: Pilot Trial: Comparison of Flow Patterns

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Pilot Trial: Comparison of Flow Patterns. Is There a Difference Between sewed-in and "Sutureless" Bioprosthetic Aortic Heart Valves?

Brief 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.

Detailed Summary:
Sponsor: Medical University of Vienna

Current Primary Outcome:

• Comparison of maximum and minimum velocity under patient specific conditions [ Time Frame: between 6 months and 4 years after aortic valve replacement ]
• Comparison of the effective orifice area under patient specific conditions [ Time Frame: between 6 months and 4 years after aortic valve replacement ]
• Comparison of the percentage of turbulent flow under patient specific conditions [ Time Frame: between 6 months and 4 years after aortic valve replacement ]
• Comparison of the pressure drop under patient specific conditions [ Time Frame: between 6 months and 4 years after aortic valve replacement ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Patient-specific, computer simulated pressure gradients compared to echocardiographically obtained pressure gradients. [ Time Frame: between 6 months and 4 years after aortic valve replacement ]

  The first secondary outcome measure is the comparison of

  -pressure gradients

  as computed by the model against the same data collected standardly with echocardiographic technique. Differences will be quantified.

  If positive (< 10%), this assessment would enhance the use of patient-specific models in clinics as a predictive tool for detailed haemodynamics."

• Patient-specific, computer simulated peak velocity compared to echocardiographically obtained peak velocity. [ Time Frame: between 6 months and 4 years after aortic valve replacement ]

  The second secondary outcome measure is the comparison of

  -peak velocity

  as computed by the model against the same data collected standardly with echocardiographic technique. Differences will be quantified.

  If positive (< 10%), this assessment would enhance the use of patient-specific models in clinics as a predictive tool for detailed haemodynamics."

Original Secondary Outcome: Same as current

Information By: Medical University of Vienna

Dates:
Date Received: October 22, 2014
Date Started: October 2014
Date Completion:
Last Updated: September 12, 2016
Last Verified: September 2016