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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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02005640
Enrollment
150
Registered
2013-12-09
Start date
2011-12-31
Completion date
2012-09-30
Last updated
2015-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Stenosis

Brief 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.

Interventions

None listed

Sponsors

Aarhus University Hospital Skejby
Lead SponsorOTHER

Study design

Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frame
Rate of no/ mild paravalvular leakage before and after introduction of routing preoperative MSCT1 week to 3 months post-TAVI
MSCT vs. echocardiographic aortic valve sizing before TAVItime of TAVI
THV size before and after introduction of routing preoperative MSCTtime of TAVI

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026