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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

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ClinicalTrials.gov Identifier: NCT02005640
Recruitment Status : Completed
First Posted : December 9, 2013
Last Update Posted : March 19, 2015
Sponsor:
Information provided by (Responsible Party):
Lars Romer Krusell, Aarhus University Hospital Skejby

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.

Condition or disease
Aortic Stenosis

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Study Type : Observational
Actual Enrollment : 150 participants
Time Perspective: Retrospective
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
Study Start Date : December 2011
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine


Group/Cohort
MSCT-based prothesis sizing
Echocardiographic-based prothesis sizing



Primary Outcome Measures :
  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 ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Primary analysis will be done in patients with a successful THV implantation and availability of high quality echocardiographic assessment and in the post routing MSCT group on the availability of a high quality MSCT scan.
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02005640


Locations
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Denmark
Department of Cardiology and Cardiothoracic Surgery, Aarhus University Hospital
Aarhus N, Denmark, 8000
Sponsors and Collaborators
Aarhus University Hospital Skejby

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Responsible Party: Lars Romer Krusell, MD, Aarhus University Hospital Skejby
ClinicalTrials.gov Identifier: NCT02005640     History of Changes
Other Study ID Numbers: MSCT-TAVI 1
First Posted: December 9, 2013    Key Record Dates
Last Update Posted: March 19, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
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Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction