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Ascending Aortic Dilation in BiAV After TAVR

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ClinicalTrials.gov Identifier: NCT03051334
Recruitment Status : Unknown
Verified February 2017 by Hyung-Kwan Kim, Seoul National University Hospital.
Recruitment status was:  Recruiting
First Posted : February 13, 2017
Last Update Posted : February 13, 2017
Sponsor:
Information provided by (Responsible Party):
Hyung-Kwan Kim, Seoul National University Hospital

Study Description
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Brief 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).

Condition or disease Intervention/treatment
Aortic Valve Stenosis Other: diagnosed as bicuspid aortic valve

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 Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Changes in Ascending Aorta Size After Transcatheter Aortic Valve Replacement in Severe Bicuspid Aortic Stenosis: A Pilot Study With Echocardiographic Follow-up
Actual Study Start Date : January 1, 2007
Estimated Primary Completion Date : December 30, 2017
Estimated Study Completion Date : December 30, 2017

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Groups and Cohorts
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Group/Cohort Intervention/treatment
BiAV
Bicuspid aortic valve
 Other: diagnosed as bicuspid aortic valve
TAV
Tricuspid aortic valve


Outcome Measures
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Primary Outcome Measures :
  1. changes in dimension of ascending aorta [ Time Frame: baseline and 1year after TAVR ]
    the annual growth rate of ascending aorta(mm/year) using echocardiography


Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Severe AS who underwent TAVR
Criteria

Inclusion Criteria:

  • Severe AS who underwent TAVR

Exclusion Criteria:

  • ascending aorta more than 50mm
Contacts and Locations
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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): NCT03051334


Contacts
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Contact: Ji-Hyun Jung, MD 82-2-2072-0243 jbjhyun@naver.com
Contact: Hyung-Kwan Kim, MD, PhD 82-2-2072-0243

Locations
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Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Hyung-Kwan Kim, MD    82-2-2072-0243      
Principal Investigator: Hyung-Kwan Kim, MD         
Sponsors and Collaborators
Seoul National University Hospital
More Information
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Responsible Party: Hyung-Kwan Kim, Director, Division of Cardiology, Clinical Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03051334    
Other Study ID Numbers: 1701-104-825
First Posted: February 13, 2017    Key Record Dates
Last Update Posted: February 13, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Constriction, Pathologic
Pathological Conditions, Anatomical
Heart Valve Diseases
 Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction