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

March 18, 2015 updated by: Lars Romer Krusell, Aarhus University Hospital Skejby

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.

Study Overview

Status

Completed

Conditions

Aortic Stenosis

Study Type

Observational

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Denmark
- - Aarhus N, Denmark, 8000
    - Department of Cardiology and Cardiothoracic Surgery, Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of no/ mild paravalvular leakage before and after introduction of routing preoperative MSCT Time Frame: 1 week to 3 months post-TAVI	1 week to 3 months post-TAVI
MSCT vs. echocardiographic aortic valve sizing before TAVI Time Frame: time of TAVI	time of TAVI
THV size before and after introduction of routing preoperative MSCT Time Frame: time of TAVI	time of TAVI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aarhus University Hospital Skejby

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

December 3, 2013

First Submitted That Met QC Criteria