ADVANCE ASO AMPLATZER™ Atrial Septal Occluder Post Market Surveillance Study
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 602
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.)
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
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)
Children's Hospital Los Angeles
🇺🇸Los Angeles, California, United States
Ronald Reagan UCLA Medical Center
🇺🇸Los Angeles, California, United States
Nationwide Children's Hospital
🇺🇸Columbus, Ohio, United States
Texas Children's Hospital / Baylor College of Medicine
🇺🇸Houston, Texas, United States
The University of Texas Health Science Center at Houston/Memorial Hermann Hospital
🇺🇸Houston, Texas, United States
University of Washington
🇺🇸Seattle, Washington, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Florida Hospital Orlando
🇺🇸Orlando, Florida, United States
Cohen Children's Medical Center
🇺🇸New Hyde Park, New York, United States
Providence Medical Research Group
🇺🇸Spokane, Washington, United States
Kaiser Permanente Los Angeles Medical Center
🇺🇸Los Angeles, California, United States
Boston Children's Hospital
🇺🇸Boston, Massachusetts, United States
New York Presbyterian/Cornell
🇺🇸New York, New York, United States
Clearwater Cardiovascular Consultants
🇺🇸Clearwater, Florida, United States
Mount Sinai Hospital
🇺🇸New York, New York, United States
North Austin Medical Center
🇺🇸Austin, Texas, United States
Children's Hospital of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Iowa Heart Center / Mercy Medical Center
🇺🇸West Des Moines, Iowa, United States
All Children's Hospital
🇺🇸Saint Petersburg, Florida, United States
Arnold Palmer Hospital for Children
🇺🇸Orlando, Florida, United States
University of Southern California
🇺🇸Los Angeles, California, United States
University of Pennslyvania
🇺🇸Philadelphia, Pennsylvania, United States
Children's Hospital of New York - Presbyterian
🇺🇸New York, New York, United States
University of Alabama
🇺🇸Birmingham, Alabama, United States
Rady Children's Hospital
🇺🇸San Diego, California, United States
Tampa General Hospital
🇺🇸Tampa, Florida, United States
Riley Hospital for Children
🇺🇸Indianapolis, Indiana, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Children's Hospitals and Clinics of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Primary Children's Hospital
🇺🇸Salt Lake City, Utah, United States
Aurora St. Luke's Medical Center
🇺🇸Milwaukee, Wisconsin, United States
Children's Hospital of Michigan
🇺🇸Detroit, Michigan, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Holy Spirit Hospital
🇺🇸Camp Hill, Pennsylvania, United States
Pinnacle Health
🇺🇸Harrisburg, Pennsylvania, United States
Driscoll Children's Hospital
🇺🇸Corpus Christi, Texas, United States
Inova Fairfax Hospital
🇺🇸Falls Church, Virginia, United States
Seattle Children's Hospital
🇺🇸Seattle, Washington, United States
University of Wisconsin
🇺🇸Madison, Wisconsin, United States
Valley Children's Hospital
🇺🇸Madera, California, United States
Huntington Memorial Hospital
🇺🇸Pasadena, California, United States
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States
Baptist Medical Center
🇺🇸Jacksonville, Florida, United States
Advocate Christ Medical Center
🇺🇸Oak Lawn, Illinois, United States
Sunrise Hospital
🇺🇸Las Vegas, Nevada, United States
Dartmouth Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
The Ohio State University
🇺🇸Columbus, Ohio, United States
Geisinger Medical Center
🇺🇸Danville, Pennsylvania, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States
Albany Medical College
🇺🇸Albany, New York, United States
University of Arizona
🇺🇸Tucson, Arizona, United States
Houston Methodist DeBakey Heart and Vascular Center
🇺🇸Houston, Texas, United States
Stanford University Medical Center
🇺🇸Palo Alto, California, United States
University of Arkansas
🇺🇸Little Rock, Arkansas, United States
Children's Healthcare of Atlanta
🇺🇸Atlanta, Georgia, United States
Yale New Haven Hospital
🇺🇸New Haven, Connecticut, United States
Children's Hospital
🇺🇸New Orleans, Louisiana, United States
Nemours/Alfred I. duPont Hospital for Children
🇺🇸Wilmington, Delaware, United States
University of Maryland
🇺🇸Baltimore, Maryland, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
University of North Carolina
🇺🇸Chapel Hill, North Carolina, United States
East Carolina University
🇺🇸Greenville, North Carolina, United States
St. Louis Children's Hospital
🇺🇸Saint Louis, Missouri, United States
Duke University Hospital
🇺🇸Durham, North Carolina, United States
University of Oklahoma
🇺🇸Oklahoma City, Oklahoma, United States