Role of Aortic Valve Composition in Pathophysiology and Diagnosis of Aortic Stenosis

NCT ID: NCT06136689

Last Updated: 2023-11-18

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

55 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-01

Study Completion Date

2025-05-01

Brief Summary

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The study aims to evaluate composition differences of aortic valves in different stages and phenotypes of aortic stenosis using non-invasive imaging and histology.

Detailed Description

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Conditions

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Aortic Stenosis Aortic Valve Disease Aortic Valve Calcification

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Severe Aortic Stenosis - High Flow, High Gradient

patients undergoing surgical aortic valve replacement for severe AS

No interventions assigned to this group

Severe Aortic Stenosis - classical Low Flow, Low Gradient

patients undergoing surgical aortic valve replacement for severe AS

No interventions assigned to this group

Severe Aortic Stenosis - paradoxical Low Flow, Low Gradient

patients undergoing surgical aortic valve replacement for severe AS

No interventions assigned to this group

Moderate Aortic Stenosis

patients undergoing aortic root replacement (Bentall procedure)

No interventions assigned to this group

Heart Transplant

patients undergoing orthotopic heart transplant for any reason

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* aortic valve replacement or heart transplant as part of standard care decided by the local Heart Team
* pre-surgical computed tomography angiography
* informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Polish Cardiac Society

OTHER

Sponsor Role collaborator

Medical University of Warsaw

OTHER

Sponsor Role lead

Responsible Party

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Kajetan Grodecki

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zenon Huczek, MD,PhD

Role: STUDY_DIRECTOR

Medical University of Warsaw

Locations

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Medical University of Silesia

Katowice, , Poland

Site Status RECRUITING

Poznan University of Medical Sciences

Poznan, , Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Kajetan Grodecki, MD, PhD

Role: CONTACT

0048 660675782

Facility Contacts

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Radoslaw Gocol, MD, PhD

Role: primary

Anna Olasinska-Wisniewska, MD, PhD

Role: primary

Tomasz Urbanowicz, MD, PhD

Role: backup

References

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Grodecki K, Tamarappoo BK, Huczek Z, Jedrzejczyk S, Cadet S, Kwiecinski J, Rymuza B, Parma R, Olasinska-Wisniewska A, Fijalkowska J, Protasiewicz M, Walczak A, Nowak A, Gocol R, Slomka PJ, Reczuch K, Jagielak D, Grygier M, Wojakowski W, Filipiak KJ, Dey D. Non-calcific aortic tissue quantified from computed tomography angiography improves diagnosis and prognostication of patients referred for transcatheter aortic valve implantation. Eur Heart J Cardiovasc Imaging. 2021 May 10;22(6):626-635. doi: 10.1093/ehjci/jeaa304.

Reference Type BACKGROUND
PMID: 33247903 (View on PubMed)

Other Identifiers

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1WR/DAR15

Identifier Type: -

Identifier Source: org_study_id

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