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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02288871
Other study ID # 1790/2013-1
Secondary ID
Status Recruiting
Phase N/A
First received October 22, 2014
Last updated March 26, 2018
Start date October 2014
Est. completion date December 2021

Study information

Verified date March 2018
Source Medical University of Vienna
Contact Claus Rath, MD
Phone 0043-1-40400-69660
Email claus.rath@meduniwien.ac.at
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date December 2021
Est. primary completion date December 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Austria Medical University of Vienna Vienna

Sponsors (2)

Lead Sponsor Collaborator
Medical University of Vienna University College, London

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary Comparison of maximum and minimum velocity under patient specific conditions between 6 months and 4 years after aortic valve replacement
Primary Comparison of the effective orifice area under patient specific conditions between 6 months and 4 years after aortic valve replacement
Primary Comparison of the percentage of turbulent flow under patient specific conditions between 6 months and 4 years after aortic valve replacement
Primary Comparison of the pressure drop under patient specific conditions between 6 months and 4 years after aortic valve replacement
Secondary Patient-specific, computer simulated pressure gradients compared to echocardiographically obtained pressure gradients. 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."
between 6 months and 4 years after aortic valve replacement
Secondary Patient-specific, computer simulated peak velocity compared to echocardiographically obtained peak velocity. 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."
between 6 months and 4 years after aortic valve replacement
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