Validation of a Novel, Non-Dimensional Approach for Estimation of Pressure

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04600739
Study type	Observational
Source	German Heart Institute
Contact	Titus Kühne, Prof. Dr.
Phone	+49 30 4593 2078
Email	titus.kuehne@dhzb.de
Status	Recruiting
Phase
Start date	October 28, 2019
Completion date	June 30, 2021

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Validation of a Novel, Non-Dimensional Approach for Estimation of Pressure Gradients in Aortic Stenosis — AVD-PowerLaw

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms