Los Angeles, California 90033

  • Atrial Septal Defect Secundum

Purpose:

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.)


Study summary:

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.


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


Study is Available At:


Original ID:

PS130046


NCT ID:

NCT02353351


Secondary ID:


Study Acronym:

ASO 522


Brief Title:

ADVANCE ASO AMPLATZER™ Atrial Septal Occluder Post Market Surveillance Study


Official Title:

Closure of Atrial Septal Defects With the AMPLATZER™ Septal Occluder (ASO) Post Market Surveillance Study


Overall Status:

Terminated


Study Phase:

N/A


Genders:

N/A


Minimum Age:

N/A


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Abbott Medical Devices


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:

The sponsor's study closure justification ad


Study Type:

Observational


Study Design:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

602


Enrollment Type:

Actual


Overall Contact Information

Official Name:Ashish Oza
Study Director
Abbott Medical Devices

Study Dates

Start Date:January 19, 2015
Completion Date:February 24, 2017
Completion Type:Actual
Primary Completion Date:February 24, 2017
Primary Completion Type:Actual
Verification Date:January 2019
Last Changed Date:January 31, 2019
First Received Date:December 2, 2014

Study Outcomes

Outcome Type:Primary Outcome
Measure:Cumulative incidence of cardiac erosion
Time Frame:1 year
Safety Issues:False
Description:Cumulative incidence of erosion will be reported as: • The number of erosions per 8000 subjects.
Outcome Type:Secondary Outcome
Measure:Aortic Rim Measurements (< 5 mm, ≥ 5 mm)
Time Frame:1 year
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Atrio-Ventricular (AV) Valve Rim Measurements (< 5 mm, ≥ 5 mm)
Time Frame:1 year
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Superior Vena Cava (SVC) Rim Measurements (< 5 mm, ≥ 5 mm)
Time Frame:1 year
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Inferior Vena Cava (IVC) Rim Measurements (< 5 mm, ≥ 5 mm)
Time Frame:1 year
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Other Evaluable Rim Measurements (< 5 mm, ≥ 5 mm)
Time Frame:1 year
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Ratio of Defect Size (Diameter) to Septal Length (< 0.5:1, ≥ 0.5:1)
Time Frame:1 year
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Ratio of Defect Size (Diameter) to Septal Width (< 0.5:1, ≥ 0.5:1)
Time Frame:1 year
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Device Splaying the Aorta (Yes, No)
Time Frame:1 year
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Device Impingement of the Aorta (Yes, No)
Time Frame:1 year
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Device Abutting the Aorta (Yes, No)
Time Frame:1 year
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Age (< 14, ≥ 14 years)
Time Frame:1 year
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Gender (Male, Female)
Time Frame:1 year
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Device Size Implanted (< 18 mm, ≥ 18 mm)
Time Frame:1 year
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Device Size to Defect Size (< 1.5:1, ≥ 1.5:1)
Time Frame:1 year
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Body Surface Area (<1.5 m2 and ≥ 1.5m2)
Time Frame:1 year
Safety Issues:False

Study Interventions

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

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Abbott Medical Devices

Samples and Retentions

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.
Sample Method:Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

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