Ascending Aortic Dilation in BiAV After TAVR | NCT03051334

Studies
Ascending Aortic Dilation in BiAV After TAVR

NCT03051334

Sponsor

Seoul National University Hospital

Status

Unknown status

Last Update Posted

Feb 13, 2017Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Aortic Valve Stenosis

Interventions

diagnosed as bicuspid aortic valve

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2007Actual

Primary Completion Date

Dec 30, 2017Estimated

Completion Date

Dec 30, 2017Estimated

First Submitted Date

Feb 8, 2017

First Submission Date that Met QC Criteria

Feb 8, 2017

First Posted Date

Feb 13, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 8, 2017

Last Update Posted Date

Feb 13, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hyung-Kwan Kim, Director, Division of Cardiology, Clinical Professor, Seoul National University HospitalPrincipal Investigator

Lead Sponsor

Seoul National University HospitalOTHER

Collaborators

Not provided

Description Module

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).

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BiAV		Bicuspid aortic valve	Other: diagnosed as bicuspid aortic valve
TAV		Tricuspid aortic valve

Interventions

Name	Type	Description	Arm Group Labels	Other Names
diagnosed as bicuspid aortic valve	Other		BiAV

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Severe AS who underwent TAVR

Exclusion Criteria:

ascending aorta more than 50mm

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Severe AS who underwent TAVR

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ji-Hyun Jung, MD	Contact	82-2-2072-0243		jbjhyun@naver.com
Hyung-Kwan Kim, MD, PhD	Contact	82-2-2072-0243

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital	Recruiting	Seoul			South Korea

Condition Browse Module

MeSH Terms

ID	Term
D001024	Aortic Valve Stenosis

Ancestor Terms

ID	Term
D000082862	Aortic Valve Disease
D006349	Heart Valve Diseases
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided