Validation of a Novel, Non-Dimensional Approach for Estimation of Pressure Gradients in Aortic Stenosis
AVD-PowerLaw
Entscheidungsunterstützung Bei Herzklappenerkrankungen Anhand Funktionaler Und Morphologischer Eigenschaften Mittels Methoden Der Mathematischen Modellierung Und Des Maschinellen Lernens
1 other identifier
observational
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 28, 2019
CompletedFirst Submitted
Initial submission to the registry
October 19, 2020
CompletedFirst Posted
Study publicly available on registry
October 23, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2021
CompletedOctober 23, 2020
October 1, 2020
1.2 years
October 19, 2020
October 19, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
predicted vs. cather-measured pressure gradient across the aortic valv
1 week up to 1 year
Study Arms (1)
AVD Patients
Patients suffering from aortic valve stenosis receiving replacement of the diseased valve using a TAVI procedure.
Interventions
Replacement of the aortic valve using a biological prosthesis that is inserted via a catheter.
Eligibility Criteria
\- retrospective acquisition of patients that receive TAVI
You may qualify if:
- aortic valve stenosis
- treatment via TAVI
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- German Heart Institutelead
- Charite University, Berlin, Germanycollaborator
Study Sites (1)
Deutsches Herzzemtrum Berlin
Berlin, Deutschland, 13353, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 19, 2020
First Posted
October 23, 2020
Study Start
October 28, 2019
Primary Completion
December 31, 2020
Study Completion
June 30, 2021
Last Updated
October 23, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share