Validation of a Novel, Non-Dimensional Approach for Estimation of Pressure Gradients in Aortic Stenosis
NCT ID: NCT04600739
Last Updated: 2020-10-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
200 participants
OBSERVATIONAL
2019-10-28
2021-06-30
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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CASE_ONLY
RETROSPECTIVE
Study Groups
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AVD Patients
Patients suffering from aortic valve stenosis receiving replacement of the diseased valve using a TAVI procedure.
TAVI
Replacement of the aortic valve using a biological prosthesis that is inserted via a catheter.
Interventions
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TAVI
Replacement of the aortic valve using a biological prosthesis that is inserted via a catheter.
Eligibility Criteria
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Inclusion Criteria
* treatment via TAVI
ALL
No
Sponsors
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Charite University, Berlin, Germany
OTHER
German Heart Institute
OTHER
Responsible Party
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Locations
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Deutsches Herzzemtrum Berlin
Berlin, Deutschland, Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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AVD-PowerLaw
Identifier Type: -
Identifier Source: org_study_id