Pilot Trial: Comparison of Flow Patterns

Not Applicable

• Conditions: Aortic Valve Stenosis; Aortic Valve Insufficiency
• Interventions: Radiation: Cardiac CT-scan

• Registration Number: NCT02288871
• Lead Sponsor: Medical University of Vienna

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 Description

Not available

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-10-22
• Study First Submitted QC: 2014-11-07
• Study First Posted: 2014-11-11
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-26
• Last Update Posted: 2018-03-27
• Primary Completion: 2020-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Patient underwent open aortic valve replacement with either an Edwards Magna Ease or an Edwards Intuity valve
• Implanted valve size 23mm
• Surgical access via full sternotomy or hemisternotomy
• Intuity Valve System implanted by one of the clinical investigators of the TRITON trial (http://clinicaltrials.gov/show/NCT01445171) at the Medical University of Vienna
• Post-operative ejection fraction ≥50%
• Sinus-Rhythm
• Ability to understand and comply with study procedures
• Signed informed consent

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Exclusion Criteria

• Under 18 years of age
• Emergency surgery
• Pregnancy
• Previous aortic root replacement
• Previous aortic valve replacement
• Previous or concomitant root enlargement
• Previous or concomitant repair of the ascending aorta
• Paravalvular leakage
• Ectasia of the ascending aorta
• Previous or concomitant myomectomy
• Concomitant replacement or repair of valves other than aortic
• Usage of more than 3 sutures for implantation of the Intuity Valve System
• Heavily calcified aortic root
• Glomerular filtration rate (GFR) < 30 ml/min
• Inability to understand or comply with study procedures
• Known allergic reaction to iodinated, non-ionic contrast agents

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
"Sutureless" valve	Cardiac CT-scan	Patients who underwent aortic valve replacement with a "sutureless" aortic valve. An echocardiogram and a cardiac CT-scan will be conducted.
"Sewed-in" valve	Cardiac CT-scan	Patients who underwent aortic valve replacement with a "sewed-in" aortic valve. An echocardiogram and a cardiac CT-scan will be conducted.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Patient-specific, computer simulated pressure gradients compared to echocardiographically obtained pressure gradients.	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.	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."

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria