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Occluder Size Determination in Transcatheter ASD II Closure Based on 3D TEE Assessment

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ClinicalTrials.gov Identifier: NCT02601768
Recruitment Status : Unknown
Verified November 2015 by Institute of Cardiology, Warsaw, Poland.
Recruitment status was:  Recruiting
First Posted : November 10, 2015
Last Update Posted : November 10, 2015
Sponsor:
Information provided by (Responsible Party):
Institute of Cardiology, Warsaw, Poland

Brief Summary:
The aim of this study is to determine whether three-dimensional tranesophageal echocardiography (3D TEE) assessment of ostium secundum atrial septal defect (ASD II) may be as efficient as two-dimensional (2D) TEE assessment complemented by the balloon-sizing during transcatheter closure of the defect.

Condition or disease Intervention/treatment
Ostium Secundum Atrial Septal Defect Device: Transcatheter closure of ASD II

Detailed Description:
A total of 50 consecutive patients eligible to percutaneous ASD II closure will be enrolled in the study. 3D-TEE will be performed in the diagnostic process; the images will be recorded for further investigation, however, measurments of the defect will not be taken until after the procedure. Traditional 2D-TEE together with balloon-sizing assessment of the defect will be performed in enrolled patients in order to chose a device. Control transthoracic echocardiography (TTE) will be provided twice to evaluate the outcome of transcatheter treatment: 1 day after the procedure and 6-12 months later. The previously obtained 3D images will be retrospectively assessed by 2 independent investigators excluded from the interventionalists' team. Maximum and minimum diameter, perimeter and area of the defect will be measured to propose the assumed optimal occluder size. Correlation between proposed occluder size and the device used during the procedure will be statistically analyzed.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Occluder Size Determination in Transcatheter Closure of Ostium Secundum Atrial Septal Defect Based on Three-Dimensional Echocardiography Assessment
Study Start Date : January 2015
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
ASD II
Transcatheter closure of ASD II
Device: Transcatheter closure of ASD II
Transcatheter closure of ASD II performed in our center.




Primary Outcome Measures :
  1. Correlation between the proposed and actual device size. [ Time Frame: 18 months ]
    The correlation will be analyzed after the data of the whole group has been completed.


Secondary Outcome Measures :
  1. Success rate of the procedure [ Time Frame: 12 months ]
    Localization of the occluder in two echocardiographic assessments, 1 day and 6-12 months after the procedure.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
50 consecutive adult patients with ASD II closed percutaneously in our center in the study time frame i.e.
Criteria

Inclusion Criteria:

  • ASD II suitable for percutaneous treatment
  • free and informed consent to analyze the medical data of the person concerned
  • age: patients over 16

Exclusion Criteria:

  • ASD II not suitable for percutaneous treatment
  • any valvular heart disease requiring cardiac surgery
  • no free and informed consent to analyze the medical data of the person concerned
  • age: under 16

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): NCT02601768


Contacts
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Contact: Jan Henzel, MD 600699211 ext +48 jhenzel@ikard.pl
Contact: Marcin Demkow, Prof. MD PhD mdemkow@ikard.pl

Locations
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Poland
Institute Of Cardiology Recruiting
Warsaw, Poland, 04-628
Contact: Jan Henzel, MD    223434342 ext +48    jhenzel@ikard.pl   
Sponsors and Collaborators
Institute of Cardiology, Warsaw, Poland
Investigators
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Study Director: Jan Henzel, MD Institute Of Cardiology in Warsaw
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Responsible Party: Institute of Cardiology, Warsaw, Poland
ClinicalTrials.gov Identifier: NCT02601768    
Other Study ID Numbers: 2.11/VI/15
First Posted: November 10, 2015    Key Record Dates
Last Update Posted: November 10, 2015
Last Verified: November 2015
Keywords provided by Institute of Cardiology, Warsaw, Poland:
ASD II
transcatheter closure
percutaneous closure
3D TEE
balloon-sizing
Additional relevant MeSH terms:
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Heart Septal Defects
Heart Septal Defects, Atrial
Foramen Ovale, Patent
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities