Aortic Valve Insufficiency, Aortic Valve Stenosis
Conditions
Keywords
aortic valve replacement, aortic valve bioprosthesis, hemodynamics
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.
Interventions
RADIATIONCardiac 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
University College, London
Medical University of Vienna
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Austria
Contacts
Primary ContactClaus Rath, MD
Backup ContactMartin Andreas, MD
Outcome results
None listed