Skip to main content
OpenTrials
Completed

NCT Number: NCT02005640

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Aortic Stenosis Aortic Valve Disease Aortic Valve Stenosis Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Cardiology and Cardiothoracic Surgery, Aarhus University Hospital

Aarhus N, 8000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. Rate of no/ mild paravalvular leakage before and after introduction of routing preoperative MSCT

    Time frame: 1 week to 3 months post-TAVI

  2. MSCT vs. echocardiographic aortic valve sizing before TAVI

    Time frame: time of TAVI

  3. THV size before and after introduction of routing preoperative MSCT

    Time frame: time of TAVI

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital Skejby

Other

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Dec 9, 2013
Registry last updated
Mar 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.