NCT02353351TerminatedNot Applicable
Closure of Atrial Septal Defects With the AMPLATZER™ Septal Occluder (ASO) Post Market Surveillance Study
Abbott Medical Devices65 sites in 1 country602 target enrollmentStarted: January 19, 2015Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Abbott Medical Devices
- Enrollment
- 602
- Locations
- 65
- Primary Endpoint
- Cumulative incidence of cardiac erosion
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •To participate in this clinical investigation, the patient must meet all of the following inclusion criteria:
- •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
- •Patient is willing and able to complete the follow-up requirements of this study
- •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:
- •Patient is known to have extensive congenital cardiac anomaly which can only be adequately repaired by way of cardiac surgery
- •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
- •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)
- •Patient is known to have a demonstrated intracardiac thrombus on echocardiography
- •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
- •Patient has margins of defect that are less than 5 mm to the coronary sinus, AV valves or right upper lobe pulmonary vein
Outcomes
Primary Outcomes
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 Outcomes
- 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)
- Body Surface Area (<1.5 m2 and ≥ 1.5m2)(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)
Investigators
Study Sites (65)
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