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Subclinical Aortic Valve Bioprosthesis Thrombosis Assessed With 4D CT

NCT02426307 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 274

Last updated 2022-12-12

No results posted yet for this study

Summary

TAVR is an increasingly used technique for the treatment of aortic valve stenosis. However, recent clinical experience has suggested that subclinical aortic valve bioprosthesis thrombosis may occur early after valve replacement. The frequency of this potentially ominous phenomenon on both transcatheter and surgical aortic valve bioprosthesis is unknown, as this condition is difficult to detect.

The recent development of cardiac 4D computed tomography imaging (4DCT) shows great promise for the evaluation of valve leaflet mobility and morphology.

The purpose of this study is in an observational design to assess the frequency of subclinical abnormal leaflet motion and morphology in patients treated with transcatheter or surgical aortic valve bioprosthesis. In addition, the 'natural evolution' of this phenomenon as well as its relation to medical treatment and MACCE will be assessed.

Conditions

  • Aortic Valve Stenosis

Interventions

PROCEDURE

TAVR

TAVR: Transcatheter Aortic Valve Replacement

PROCEDURE

SAVR

SAVR: surgical Aortic Valve Replacement

Sponsors & Collaborators

  • Cedars-Sinai Medical Center

    collaborator OTHER

  • Rigshospitalet, Denmark

    lead OTHER

Principal Investigators

  • Lars Søndergaard, MD · Department of Cardiology, The Heart Center, Capital Region of Copenhagen, University of Copenhagen, Denmark

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2018-09-30
Completion
2030-04-30

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02426307 on ClinicalTrials.gov