Brief Title
Validation of a Novel, Non-Dimensional Approach for Estimation of Pressure Gradients in Aortic Stenosis
Official Title
Entscheidungsunterstützung Bei Herzklappenerkrankungen Anhand Funktionaler Und Morphologischer Eigenschaften Mittels Methoden Der Mathematischen Modellierung Und Des Maschinellen Lernens
Brief Summary
A novel, image-based model for estimation of the pressure gradient across stenosed aortic valves is compared against invasively measured pressure gradients from clinical routine.
Detailed Description
Using temporally resolved computed tomography images, the patient-specific geometry of the stenosed aortic valve during peak systole is reconstructed. Using this geometry, the projected area of the aortic valve's orifice (AVA) is calculated. Additionally, the left ventricular geometry is reconstructed for the complete heart cycle. Using the information of the left ventricular volume change, the patient-specific flow profile and peak-systolic flow (Q)is calculated. Using this information, the pressure gradient is calculated using a power law estimation of the form PG = a * AVA^b * Q^c. The model generation and parameter fit is described in [1]. To validate this model, retrospective data of patients receiving a catheter-based replacement of the aortic valve (TAVI) is collected. For those patients, CT images are already acquired for treatment planning and the invasive pressure measurements are performed during replacement of the aortic valve. Therefore, no additionally steps are required. Using the CT images the patient-specific aortic valve area ad flow rate are calculated. This information is then used for estimation of the pressure gradient using the power law model. The catheter-based pressure gradient is calculated as the difference between the peak-systolic pressure in the left ventricle and the ascending aorta before implantation of the prosthesis. [1] Franke et al.; Towards improving the accuracy of aortic transvalvular pressure gradients: rethinking Bernoulli; Medical & Biological Engineering & Computing (2020); https://doi.org/10.1007/s11517-020-02186-w
Study Type
Observational
Primary Outcome
predicted vs. cather-measured pressure gradient across the aortic valv
Condition
Aortic Valve Stenosis
Intervention
TAVI
Study Arms / Comparison Groups
AVD Patients
Description: Patients suffering from aortic valve stenosis receiving replacement of the diseased valve using a TAVI procedure.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
200
Start Date
October 28, 2019
Completion Date
June 30, 2021
Primary Completion Date
December 31, 2020
Eligibility Criteria
Inclusion Criteria: - aortic valve stenosis - treatment via TAVI
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
, +49 30 4593 2078, [email protected]
Location Countries
Germany
Location Countries
Germany
Administrative Informations
NCT ID
NCT04600739
Organization ID
AVD-PowerLaw
Responsible Party
Sponsor
Study Sponsor
German Heart Institute
Collaborators
Charite University, Berlin, Germany
Study Sponsor
, ,
Verification Date
October 2020