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ADVANCE ASO AMPLATZER™ Atrial Septal Occluder Post Market Surveillance Study (ASO 522)

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ClinicalTrials.gov Identifier: NCT02353351
Recruitment Status : Terminated (The sponsor's study closure justification addressed the 522 Order's questions.)
First Posted : February 2, 2015
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Prospective, multicenter, case-cohort study.To identify potential risk factors associated with the occurrence of erosion due to implantation of the AMPLATZER™ Septal Occluder (ASO.)

Condition or disease Intervention/treatment
Atrial Septal Defect Secundum Device: atrial septal occluder

Detailed Description:
This study will enroll 8000 subjects. The sub-cohort will consist of 160 (2%) subjects, randomly selected from the full cohort. The analysis population will consist of all subjects in the sub-cohort, combined with all subjects with erosion events who are not in the sub-cohort. A detailed assessment of risk factors will be conducted on the subjects in this analysis population.

Study Design

Study Type : Observational
Actual Enrollment : 602 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Closure of Atrial Septal Defects With the AMPLATZER™ Septal Occluder (ASO) Post Market Surveillance Study
Actual Study Start Date : January 19, 2015
Primary Completion Date : February 24, 2017
Study Completion Date : February 24, 2017
Groups and Cohorts

Intervention Details:
    Device: atrial septal occluder
    Single arm atrial septal defect closure with the AMPLATZER Septal Occluder
    Other Name: AMPLATZER Septal Occluder

Outcome Measures

Primary Outcome Measures :
  1. Cumulative incidence of cardiac erosion [ Time Frame: 1 year ]

    Cumulative incidence of erosion will be reported as:

    • The number of erosions per 8000 subjects.



Secondary Outcome Measures :
  1. Aortic Rim Measurements (< 5 mm, ≥ 5 mm) [ Time Frame: 1 year ]
  2. Atrio-Ventricular (AV) Valve Rim Measurements (< 5 mm, ≥ 5 mm) [ Time Frame: 1 year ]
  3. Superior Vena Cava (SVC) Rim Measurements (< 5 mm, ≥ 5 mm) [ Time Frame: 1 year ]
  4. Inferior Vena Cava (IVC) Rim Measurements (< 5 mm, ≥ 5 mm) [ Time Frame: 1 year ]
  5. Other Evaluable Rim Measurements (< 5 mm, ≥ 5 mm) [ Time Frame: 1 year ]
  6. Ratio of Defect Size (Diameter) to Septal Length (< 0.5:1, ≥ 0.5:1) [ Time Frame: 1 year ]
  7. Ratio of Defect Size (Diameter) to Septal Width (< 0.5:1, ≥ 0.5:1) [ Time Frame: 1 year ]
  8. Device Splaying the Aorta (Yes, No) [ Time Frame: 1 year ]
  9. Device Impingement of the Aorta (Yes, No) [ Time Frame: 1 year ]
  10. Device Abutting the Aorta (Yes, No) [ Time Frame: 1 year ]
  11. Age (< 14, ≥ 14 years) [ Time Frame: 1 year ]
  12. Gender (Male, Female) [ Time Frame: 1 year ]
  13. Device Size Implanted (< 18 mm, ≥ 18 mm) [ Time Frame: 1 year ]
  14. Device Size to Defect Size (< 1.5:1, ≥ 1.5:1) [ Time Frame: 1 year ]
  15. Body Surface Area (<1.5 m2 and ≥ 1.5m2) [ Time Frame: 1 year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients indicated for ASD closure have echocardiographic evidence of ostium secundum atrial septal defect and clinical evidence of right ventricular volume overload (such as, 1.5:1 degree of left-to-right shunt or RV enlargement).

The subject population includes vulnerable patients.

Criteria

Inclusion Criteria:

To participate in this clinical investigation, the patient must meet all of the following inclusion criteria:

  1. Patient indicated for ASD closure who has echocardiographic evidence of ostium secundum atrial septal defect and clinical evidence of right ventricular volume overload (such as, 1.5:1 degree of left-to-right shunt or RV enlargement) and is implanted with the ASO device Note: This does not include the indication for closure of a fenestration following a fenestrated Fontan procedure
  2. Patient is willing and able to complete the follow-up requirements of this study
  3. Patient signs the informed consent (or a legal representative signs the informed consent.)

Exclusion Criteria:

Patient is not eligible for clinical investigation participation if he/she meets any of the following exclusion criteria:

  1. Patient is known to have extensive congenital cardiac anomaly which can only be adequately repaired by way of cardiac surgery
  2. Patient is known to have sepsis within 1 month prior to implantation, or any systemic infection that cannot be successfully treated prior to device placement
  3. Patient is known to have a bleeding disorder, untreated ulcer, or any other contraindications to aspirin therapy (unless another anti-platelet agent can be administered for 6 months)
  4. Patient is known to have a demonstrated intracardiac thrombus on echocardiography
  5. Patient whose size (such as, too small for transesophageal echocardiography probe, catheter size) or condition (active infection, etc.) would cause the patient to be a poor candidate for cardiac catheterization
  6. Patient has margins of defect that are less than 5 mm to the coronary sinus, AV valves or right upper lobe pulmonary vein
Contacts and Locations

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): NCT02353351


  Show 65 Study Locations
Sponsors and Collaborators
St. Jude Medical
Investigators
Study Director: Ashish Oza St. Jude Medical
More Information

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT02353351     History of Changes
Other Study ID Numbers: PS130046
First Posted: February 2, 2015    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Heart Septal Defects
Heart Septal Defects, Atrial
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities