Transcatheter Heart Valve (THV) Sizing and Leakage After Transcatheter Aortic Valve Implantation (TAVI) Before and After Establishing Routine Preprocedure Multi Slice Computerized Tomography (MSCT) Aortic Assessment. A Retrospective Registry Study

NCT ID: NCT02005640

Last Updated: 2015-03-19

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

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-12-31

Study Completion Date

2012-09-30

Brief Summary

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The objective of this study is to evaluate the effect of annular sizing strategy (MDCT versus TEE) in transcatheter aortic valve implantation on the prevalence and severity of paravalvular regurgitation.

Detailed Description

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Conditions

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Aortic Stenosis

Study Design

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Study Time Perspective

RETROSPECTIVE

Study Groups

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MSCT-based prothesis sizing

No interventions assigned to this group

Echocardiographic-based prothesis sizing

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients implanted with a THV at Aarhus University Hospital

Exclusion Criteria

* Learning curve patients (the first 40 patients implanted with a THV device at Aarhus University Hospital, Skejby).
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aarhus University Hospital Skejby

OTHER

Sponsor Role lead

Responsible Party

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Lars Romer Krusell

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Cardiology and Cardiothoracic Surgery, Aarhus University Hospital

Aarhus N, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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MSCT-TAVI 1

Identifier Type: -

Identifier Source: org_study_id

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