ADVANCE ASO AMPLATZER™ Atrial Septal Occluder Post Market Surveillance Study

Terminated

• Conditions: Atrial Septal Defect Secundum

• Registration Number: NCT02353351
• Lead Sponsor: Abbott Medical Devices

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.)

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 Timeline

• Study First Submitted: 2014-12-02
• Study Start: 2015-01-19
• Study First Submitted QC: 2015-01-28
• Study First Posted: 2015-02-02
• Primary Completion: 2017-02-24
• Study Completion: 2017-02-24
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-31
• Last Update Posted: 2019-02-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 602

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cumulative incidence of cardiac erosion	1 year	Cumulative incidence of erosion will be reported as: • The number of erosions per 8000 subjects.

Secondary Outcome Measures

Name	Time	Method
Body Surface Area (<1.5 m2 and ≥ 1.5m2)	1 year
Superior Vena Cava (SVC) Rim Measurements (< 5 mm, ≥ 5 mm)	1 year
Inferior Vena Cava (IVC) Rim Measurements (< 5 mm, ≥ 5 mm)	1 year
Device Size Implanted (< 18 mm, ≥ 18 mm)	1 year
Other Evaluable Rim Measurements (< 5 mm, ≥ 5 mm)	1 year
Ratio of Defect Size (Diameter) to Septal Length (< 0.5:1, ≥ 0.5:1)	1 year
Ratio of Defect Size (Diameter) to Septal Width (< 0.5:1, ≥ 0.5:1)	1 year
Device Impingement of the Aorta (Yes, No)	1 year
Device Abutting the Aorta (Yes, No)	1 year
Age (< 14, ≥ 14 years)	1 year
Aortic Rim Measurements (< 5 mm, ≥ 5 mm)	1 year
Atrio-Ventricular (AV) Valve Rim Measurements (< 5 mm, ≥ 5 mm)	1 year
Device Splaying the Aorta (Yes, No)	1 year
Gender (Male, Female)	1 year
Device Size to Defect Size (< 1.5:1, ≥ 1.5:1)	1 year

Trial Locations

Locations (65)

University of Alabama; 🇺🇸 Birmingham, Alabama, United States

University of Arizona; 🇺🇸 Tucson, Arizona, United States

University of Arkansas; 🇺🇸 Little Rock, Arkansas, United States

Children's Hospital Los Angeles; 🇺🇸 Los Angeles, California, United States

Kaiser Permanente Los Angeles Medical Center; 🇺🇸 Los Angeles, California, United States

University of Southern California; 🇺🇸 Los Angeles, California, United States

Ronald Reagan UCLA Medical Center; 🇺🇸 Los Angeles, California, United States

Valley Children's Hospital; 🇺🇸 Madera, California, United States

Stanford University Medical Center; 🇺🇸 Palo Alto, California, United States

Huntington Memorial Hospital; 🇺🇸 Pasadena, California, United States

Scroll for more (55 remaining)