Ascending Aortic Dilation in BiAV After TAVR

February 8, 2017 updated by: Hyung-Kwan Kim, Seoul National University Hospital

Changes in Ascending Aorta Size After Transcatheter Aortic Valve Replacement in Severe Bicuspid Aortic Stenosis: A Pilot Study With Echocardiographic Follow-up

This study sought to evaluate changes in ascending aorta size after transcatheter aortic valve replacement (TAVR) in patients with bicuspid aortic valve (BiAV) compared with patients with tricuspid aortic valve (TAV).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The growth rate of ascending aorta was calculated as annual growth rate using baseline and the last echocardiography. The difference in ascending aorta growth rates between the two groups (BiAV and TAV) were analyzed by independent t-test.

Study Type

Observational

Enrollment (Anticipated)

100

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

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Seoul National University Hospital
        • Contact:
          • Hyung-Kwan Kim, MD
          • Phone Number: 82-2-2072-0243
        • Principal Investigator:
          • Hyung-Kwan Kim, MD

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

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Severe AS who underwent TAVR

Description

Inclusion Criteria:

  • Severe AS who underwent TAVR

Exclusion Criteria:

  • ascending aorta more than 50mm

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
BiAV
Bicuspid aortic valve
Other: diagnosed as bicuspid aortic valve
TAV
Tricuspid aortic valve

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
changes in dimension of ascending aorta
Time Frame: baseline and 1year after TAVR
the annual growth rate of ascending aorta(mm/year) using echocardiography
baseline and 1year after TAVR

Collaborators and Investigators

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

Sponsor

Seoul National University Hospital

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 (Actual)

January 1, 2007

Primary Completion (Anticipated)

December 30, 2017

Study Completion (Anticipated)

December 30, 2017

Study Registration Dates

First Submitted

February 8, 2017

First Submitted That Met QC Criteria

February 8, 2017

First Posted (Actual)

February 13, 2017

Study Record Updates

Last Update Posted (Actual)

February 13, 2017

Last Update Submitted That Met QC Criteria

February 8, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1701-104-825

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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