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NCT02005640 Clinical Trial

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

Aortic Stenosis Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02005640
Other study ID # MSCT-TAVI 1
Secondary ID
Status Completed
Phase N/A
First received December 3, 2013
Last updated March 18, 2015
Start date December 2011
Est. completion date September 2012

Study information
Verified date March 2015
Source Aarhus University Hospital Skejby
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Dataprotection AgencyDenmark: National Board of Health
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 150
Est. completion date September 2012
Est. primary completion date September 2012
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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).

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
Denmark Department of Cardiology and Cardiothoracic Surgery, Aarhus University Hospital Aarhus N

Sponsors (1)
Lead Sponsor Collaborator
Aarhus University Hospital Skejby

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Rate of no/ mild paravalvular leakage before and after introduction of routing preoperative MSCT 1 week to 3 months post-TAVI No
Primary MSCT vs. echocardiographic aortic valve sizing before TAVI time of TAVI No
Primary THV size before and after introduction of routing preoperative MSCT time of TAVI No
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