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NCT03051334 Clinical Trial

Ascending Aortic Dilation in BiAV After TAVR

Aortic Valve Stenosis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03051334
Other study ID # 1701-104-825
Secondary ID
Status Recruiting
Phase N/A
First received February 8, 2017
Last updated February 8, 2017
Start date January 1, 2007
Est. completion date December 30, 2017

Study information
Verified date February 2017
Source Seoul National University Hospital
Contact Ji-Hyun Jung, MD
Phone 82-2-2072-0243
Email jbjhyun@naver.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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).

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date December 30, 2017
Est. primary completion date December 30, 2017
Accepts healthy volunteers
Gender All
Age group 21 Years and older
Eligibility Inclusion Criteria:

- Severe AS who underwent TAVR

Exclusion Criteria:

- ascending aorta more than 50mm

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• diagnosed as bicuspid aortic valve

Locations
Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary changes in dimension of ascending aorta the annual growth rate of ascending aorta(mm/year) using echocardiography baseline and 1year after TAVR
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