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

Aortic Valve Stenosis Clinical Trial

— AVD-PowerLaw  

Official title:

Entscheidungsunterstützung Bei Herzklappenerkrankungen Anhand Funktionaler Und Morphologischer Eigenschaften Mittels Methoden Der Mathematischen Modellierung Und Des Maschinellen Lernens

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04600739
• Other study ID #: AVD-PowerLaw
• Status: Recruiting
• Start date: October 28, 2019
• Est. completion date: June 30, 2021

Study information

• Verified date: October 2020
• Source: German Heart Institute
• Contact: Titus Kühne, Prof. Dr.
• Phone: +49 30 4593 2078
• Email: titus.kuehne[@]dhzb.de
• Is FDA regulated: No
• Study type: Observational

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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 30, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• aortic valve stenosis

• treatment via TAVI

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Constriction, Pathologic

Intervention

Procedure:
• TAVI
Replacement of the aortic valve using a biological prosthesis that is inserted via a catheter.

Locations

Country	Name	City	State
Germany	Deutsches Herzzemtrum Berlin	Berlin	Deutschland

Sponsors (2)

Lead Sponsor	Collaborator
German Heart Institute	Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	predicted vs. cather-measured pressure gradient across the aortic valv		1 week up to 1 year