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Outcomes of Transcatheter ASD Closure Guided by 3D-TEE

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03867708
Recruitment Status : Withdrawn (No participants found)
First Posted : March 8, 2019
Last Update Posted : September 21, 2020
Sponsor:
Information provided by (Responsible Party):
Mohamed Aboelkasem Ali Mousa, Assiut University

Brief Summary:
Atrial Septal Defect (ASD) is a common cardiac diagnosis among adults.Three-dimensional transesophageal echocardiography (3D-TEE) improve the visualization of ASD, its rims and surrounding structures and can be used for guidance during percutaneous transcatheter closure. Proper device size selection is important for success of ASD device closure. 3D-TEE can assess the ASD morphology, maximal diameter, area and determine the device size without balloon sizing during percutaneous closure.There are some adverse outcomes reported in previous studies following transcatheter secundum ASD closure as: residual shunt, new onset atrial fibrillation(AF) and mitral regurgitation(MR)deterioration . These adverse outcomes are responsible for morbidity and mortality following transcatheter ASD closure, so it is essential to study risk factors associated with these adverse outcomes in order to minimize their incidence.The investigators will study the role of 3D-TEE in proper device size selection, also the percentage and predictors of adverse outcomes after device closure guided by 3D-TEE.

Condition or disease Intervention/treatment
ASD2(Secundum Atrial Septal Defect) Radiation: ASD device closure

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Outcomes of Transcatheter Closure of Secundum Atrial Septal Defect Guided by Three-dimensional Transesophageal Echocardiography
Estimated Study Start Date : December 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
patients with residual shunt
patient with residual left to right shunt detected by 2D-TTE at 6 month follow up after ASD device closure guided by 3D-TEE
Radiation: ASD device closure
transcatheter secundum ASD device closure

patients without residual shunt
patient without residual left to right shunt by 2D-TTE at 6 month follow up after ASD device closure guided by 3D-TEE
Radiation: ASD device closure
transcatheter secundum ASD device closure




Primary Outcome Measures :
  1. Detection of residual shunt, MR deterioration and new onset AF following 3D-TEE guided ASD closure [ Time Frame: six months ]
    Detection of residual shunt and MR deterioration by 2D-TTE and new-onset AF by ECG at six month follow up after ASD device closure


Secondary Outcome Measures :
  1. Clinical outcomes after six months [ Time Frame: six months ]
    Detection of mortality , cerebrovascular stroke and heart failure after six months of ASD device closure



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with secundum atrial septal defect with suitable rims for transcatheter device closure
Criteria

Inclusion Criteria:

  • Patients with suitable indication for ASD closure according to recent guidelines :

    1. Impaired functional capacity.
    2. Right atrial and/or RV enlargement.
    3. Left-to-right shunt with [Qp: Qs] ≥1.5:1.
    4. Paradoxical embolism.
  • Patients with isolated secundum ASD with sufficient rims suitable for device closure.

Exclusion Criteria:

  • Small ASD with Qp/Qs <1.5:1 or no signs of RV volume overload
  • A single defect too large for closure (>38 mm)
  • Multiple ASDs unsuitable for percutaneous closure.
  • Anterior, posterior, superior, or inferior rim <5 mm.
  • Abnormal pulmonary venous drainage.
  • Associated structural heart disease requiring cardiac surgery.
  • ASD with severe pulmonary arterial hypertension and bidirectional or right-to-left shunting.
  • Intracardiac thrombi diagnosed by echocardiography.

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): NCT03867708


Sponsors and Collaborators
Assiut University
Investigators
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Principal Investigator: Mohamed Mousa Assiut University
Publications:
Kong WK. The relation between atrial septal defect area, diameter and shape using balloon sizing and three-dimensional transoesophageal echocardiography during percutaneous closure using occlutech device. Journal of the American College of Cardiology. 2017;69(11 Supplement):1493.
Akagi T, Fujii Y, Takaya Y, Takahashi S, et al. Clinical benefit of transcatheter closure for newly developed atrial fibrillation in adult patients with atrial septal defect. Journal of the American College of Cardiology. 2018;71(11):A549.
WINDECKER S, MEIER B. Percutaneous closure of patent foramen ovale, atrial septal defects and the left atrial appendage. Essential Interventional Cardiology (Second Edition): Elsevier; 2008. p. 449-68.

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Responsible Party: Mohamed Aboelkasem Ali Mousa, Assistant lecturer, Assiut University
ClinicalTrials.gov Identifier: NCT03867708    
Other Study ID Numbers: ASD closure guided by 3D-TEE
First Posted: March 8, 2019    Key Record Dates
Last Update Posted: September 21, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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