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

Sponsor

German Heart Institute (Other)

Overall Status

Recruiting

CT.gov ID

NCT04600739

Collaborator

Charite University, Berlin, Germany (Other)

200

Enrollment

Location

20.1

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Aortic Valve Stenosis	Procedure: TAVI

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 Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Case-Only

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Oct 28, 2019

Anticipated Primary Completion Date :

Dec 31, 2020

Anticipated Study Completion Date :

Jun 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
AVD Patients Patients suffering from aortic valve stenosis receiving replacement of the diseased valve using a TAVI procedure.	Procedure: TAVI Replacement of the aortic valve using a biological prosthesis that is inserted via a catheter.

Arm

Intervention/Treatment

AVD Patients

Patients suffering from aortic valve stenosis receiving replacement of the diseased valve using a TAVI procedure.

Procedure: TAVI

Replacement of the aortic valve using a biological prosthesis that is inserted via a catheter.

Outcome Measures

Primary Outcome Measures

predicted vs. cather-measured pressure gradient across the aortic valv [1 week up to 1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

aortic valve stenosis
treatment via TAVI

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Deutsches Herzzemtrum Berlin	Berlin	Deutschland	Germany	13353

Sponsors and Collaborators

German Heart Institute
Charite University, Berlin, Germany

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

German Heart Institute

ClinicalTrials.gov Identifier:

NCT04600739

Other Study ID Numbers:

AVD-PowerLaw

First Posted:

Oct 23, 2020

Last Update Posted:

Oct 23, 2020

Last Verified:

Oct 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Aortic Valve Stenosis

Constriction, Pathologic

Study Results

No Results Posted as of Oct 23, 2020