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Efficacy of Three Dimensional Transesophageal Echocardiography for Percutaneous Device Closure in Atrial Septal Defect (ASD)

Primary Purpose

Atrial Septal Defect, Successful Device Closure

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Transcatheter device closure
Sponsored by
Asan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Atrial Septal Defect

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥18 year-old
  • Susceptible indication for atrial septal defect closure
  • Potential candidate for device closure

Exclusion Criteria:

  • Poor candidate for device closure: multiple ASDs, ect
  • Other heart disease requiring open heart surgery

Sites / Locations

  • Asan Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

transcatheter device closure

Arm Description

Choosing device size using three dimensional image and the formula without sizing balloon

Outcomes

Primary Outcome Measures

Successful device implantation

Secondary Outcome Measures

Procedure time

Full Information

First Posted
March 25, 2014
Last Updated
January 30, 2023
Sponsor
Asan Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02097758
Brief Title
Efficacy of Three Dimensional Transesophageal Echocardiography for Percutaneous Device Closure in Atrial Septal Defect
Acronym
ASD
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 2014 (undefined)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Background: Three-dimensional echocardiographic image for atrial septal defect (ASD) is useful for evaluation of defect size and shape. The investigators suggested optimal device size using three-dimensional transesophageal echocardiographic image and our formula in previous study. Purpose: In this study, the investigators seek to predict the correct device size and confirm the accuracy of the formula that we made before device closure in ASD patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Septal Defect, Successful Device Closure

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
transcatheter device closure
Arm Type
Experimental
Arm Description
Choosing device size using three dimensional image and the formula without sizing balloon
Intervention Type
Device
Intervention Name(s)
Transcatheter device closure
Intervention Description
Closure of atrial septal defect with device choosing device size with 3D image and the formula we do not use sizing balloon for choosing of the device size
Primary Outcome Measure Information:
Title
Successful device implantation
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Procedure time
Time Frame
during procedure
Other Pre-specified Outcome Measures:
Title
Complications from device
Description
migration or dehiscence of device erosion cardiac rupture
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥18 year-old Susceptible indication for atrial septal defect closure Potential candidate for device closure Exclusion Criteria: Poor candidate for device closure: multiple ASDs, ect Other heart disease requiring open heart surgery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jong-Min Song, MD,PhD
Phone
+82-2-3010-3168
Email
jmsong@amc.seoul.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jong-Min Song, MD PhD
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jong-Min Song, MD,PhD
Phone
+82-2-3010-3168
Email
jmsong@amc.seoul.kr
First Name & Middle Initial & Last Name & Degree
Jeong Yoon Jang, MD
First Name & Middle Initial & Last Name & Degree
Jong-Min Song, MD PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
28633478
Citation
Jang JY, Heo R, Cho MS, Bae J, Hong JA, Lee S, Ahn JM, Park DW, Kim DH, Kang DH, Song JK, Song JM. Efficacy of 3D transoesophageal echocardiography for transcatheter device closure of atrial septal defect without balloon sizing. Eur Heart J Cardiovasc Imaging. 2018 Jun 1;19(6):684-689. doi: 10.1093/ehjci/jex153.
Results Reference
derived

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Efficacy of Three Dimensional Transesophageal Echocardiography for Percutaneous Device Closure in Atrial Septal Defect

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