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Procedural Outcomes of Percutaneous PDA Closure: Comparative Study Between Different Devices.

Primary Purpose

Congenital Heart Disease

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Percutaneous PDA closure
Sponsored by
Assiut University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congenital Heart Disease

Eligibility Criteria

1 Month - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • all patients who are candidate for transcatheter PDA closure

Exclusion Criteria:

  1. Patients with PDA dependent pulmonary circulation.
  2. Patients with small sized PDA which is silent by auscultation
  3. Patients with large sized PDA which is unsuitable for Trans-catheter closure
  4. Patients with PDA and severe irreversible pulmonary hypertension (Eisenmenger's syndrome) (7).
  5. Patients with active infection or active infective endarteritis.
  6. Patients refusing the study.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Procedural safety
    studying the occurrence of catheter related complications including Occurrence of vascular access hematoma(Yes/No ) Occurrence of contrast induced nephropathy (Yes/No) PDA closure Device embolization (Yes/No) Cardiac tamponade (Yes/No)
    Procedural efficacy
    timing of complete closure of the PDA with no residual shunts Residual left to right shunt (Yes/No) Degree of the residual shunt (Trace, Mild , Moderate, severe) Timing of closure of the shunt( immediately postprocedural, 24 hours post procedural , 1 month post procedural )
    Procedural outcomes
    comparison of echocardiography data that will be done pre catheter closure, one day post procedure and one month later ( left ventricular and atrial dimensions-left ventricular ejection fraction-pulmonary artery systolic pressure- degree of tricuspid regurge)

    Secondary Outcome Measures

    Full Information

    First Posted
    March 7, 2020
    Last Updated
    March 9, 2020
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04303793
    Brief Title
    Procedural Outcomes of Percutaneous PDA Closure: Comparative Study Between Different Devices.
    Official Title
    Procedural Outcomes of Percutaneous PDA Closure: Comparative Study Between Different Devices.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 1, 2020 (Anticipated)
    Primary Completion Date
    May 1, 2022 (Anticipated)
    Study Completion Date
    June 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

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

    5. Study Description

    Brief Summary
    To compare safety, efficacy and procedural outcome of percutaneous PDA closure using different approaches for better characterization of device selection criteria.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Congenital Heart Disease

    7. Study Design

    Primary Purpose
    Treatment
    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

    Intervention Type
    Device
    Intervention Name(s)
    Percutaneous PDA closure
    Intervention Description
    transcatheter patent ductus arteriosus closure
    Primary Outcome Measure Information:
    Title
    Procedural safety
    Description
    studying the occurrence of catheter related complications including Occurrence of vascular access hematoma(Yes/No ) Occurrence of contrast induced nephropathy (Yes/No) PDA closure Device embolization (Yes/No) Cardiac tamponade (Yes/No)
    Time Frame
    one month
    Title
    Procedural efficacy
    Description
    timing of complete closure of the PDA with no residual shunts Residual left to right shunt (Yes/No) Degree of the residual shunt (Trace, Mild , Moderate, severe) Timing of closure of the shunt( immediately postprocedural, 24 hours post procedural , 1 month post procedural )
    Time Frame
    one month
    Title
    Procedural outcomes
    Description
    comparison of echocardiography data that will be done pre catheter closure, one day post procedure and one month later ( left ventricular and atrial dimensions-left ventricular ejection fraction-pulmonary artery systolic pressure- degree of tricuspid regurge)
    Time Frame
    one month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Month
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: all patients who are candidate for transcatheter PDA closure Exclusion Criteria: Patients with PDA dependent pulmonary circulation. Patients with small sized PDA which is silent by auscultation Patients with large sized PDA which is unsuitable for Trans-catheter closure Patients with PDA and severe irreversible pulmonary hypertension (Eisenmenger's syndrome) (7). Patients with active infection or active infective endarteritis. Patients refusing the study.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ahmed Mohamed Moheb El-Din
    Phone
    01060964666
    Email
    ahmedmoheb34567@gmail.com

    12. IPD Sharing Statement

    Learn more about this trial

    Procedural Outcomes of Percutaneous PDA Closure: Comparative Study Between Different Devices.

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