Clinical Trial: ADVANCE ASO AMPLATZER™ Atrial Septal Occluder Post Market Surveillance Study
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational
Official Title: Closure of Atrial Septal Defects With the AMPLATZER™ Septal Occluder (ASO) Post Market Surveillance Study
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 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.
Sponsor: St. Jude Medical
Current Primary Outcome: Cumulative incidence of cardiac erosion [ Time Frame: 1 year ]
Cumulative incidence of erosion will be reported as:
• The number of erosions per 8000 subjects.
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Aortic Rim Measurements (< 5 mm, ≥ 5 mm) [ Time Frame: 1 year ]
- Atrio-Ventricular (AV) Valve Rim Measurements (< 5 mm, ≥ 5 mm) [ Time Frame: 1 year ]
- Superior Vena Cava (SVC) Rim Measurements (< 5 mm, ≥ 5 mm) [ Time Frame: 1 year ]
- Inferior Vena Cava (IVC) Rim Measurements (< 5 mm, ≥ 5 mm) [ Time Frame: 1 year ]
- Other Evaluable Rim Measurements (< 5 mm, ≥ 5 mm) [ Time Frame: 1 year ]
- Ratio of Defect Size (Diameter) to Septal Length (< 0.5:1, ≥ 0.5:1) [ Time Frame: 1 year ]
- Ratio of Defect Size (Diameter) to Septal Width (< 0.5:1, ≥ 0.5:1) [ Time Frame: 1 year ]
- Device Splaying the Aorta (Yes, No) [ Time Frame: 1 year ]
- Device Impingement of the Aorta (Yes, No) [ Time Frame: 1 year ]
- Device Abutting the Aorta (Yes, No) [ Time Frame: 1 year ]
- Age (< 14, ≥ 14 years) [ Time Frame: 1 year ]
- Gender (Male, Female) [ Time Frame: 1 year ]
- Device Size Implanted (< 18 mm, ≥ 18 mm) [ Time Frame: 1 year ]
- Device Size to Defect Size (< 1.5:1, ≥ 1.5:1) [ Time Frame: 1 year ]
- Body Surface Area (<1.5 m2 and ≥ 1.5m2) [ Time Frame: 1 year ]
Original Secondary Outcome: Same as current
Information By: St. Jude Medical
Dates:
Date Received: December 2, 2014
Date Started: June 2014
Date Completion: March 2019
Last Updated: December 14, 2016
Last Verified: December 2016