Atrial Septal Defect Secundum Clinical Trial
— ASO 522Official title:
Closure of Atrial Septal Defects With the AMPLATZER™ Septal Occluder (ASO) Post Market Surveillance Study
| Verified date | January 2019 |
| Source | Abbott Medical Devices |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.)
| Status | Terminated |
| Enrollment | 602 |
| Est. completion date | February 24, 2017 |
| Est. primary completion date | February 24, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Albany Medical College | Albany | New York |
| United States | Children's Healthcare of Atlanta | Atlanta | Georgia |
| United States | North Austin Medical Center | Austin | Texas |
| United States | University of Maryland | Baltimore | Maryland |
| United States | University of Alabama | Birmingham | Alabama |
| United States | Boston Children's Hospital | Boston | Massachusetts |
| United States | Holy Spirit Hospital | Camp Hill | Pennsylvania |
| United States | University of North Carolina | Chapel Hill | North Carolina |
| United States | University of Virginia | Charlottesville | Virginia |
| United States | Clearwater Cardiovascular Consultants | Clearwater | Florida |
| United States | Cleveland Clinic Foundation | Cleveland | Ohio |
| United States | Nationwide Children's Hospital | Columbus | Ohio |
| United States | The Ohio State University | Columbus | Ohio |
| United States | Driscoll Children's Hospital | Corpus Christi | Texas |
| United States | Geisinger Medical Center | Danville | Pennsylvania |
| United States | Children's Hospital of Michigan | Detroit | Michigan |
| United States | Henry Ford Hospital | Detroit | Michigan |
| United States | Duke University Hospital | Durham | North Carolina |
| United States | Inova Fairfax Hospital | Falls Church | Virginia |
| United States | East Carolina University | Greenville | North Carolina |
| United States | Pinnacle Health | Harrisburg | Pennsylvania |
| United States | Houston Methodist DeBakey Heart and Vascular Center | Houston | Texas |
| 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 | Riley Hospital for Children | Indianapolis | Indiana |
| United States | University of Mississippi Medical Center | Jackson | Mississippi |
| United States | Baptist Medical Center | Jacksonville | Florida |
| United States | Sunrise Hospital | Las Vegas | Nevada |
| United States | Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire |
| 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 | Ronald Reagan UCLA Medical Center | Los Angeles | California |
| United States | University of Southern California | Los Angeles | California |
| United States | Valley Children's Hospital | Madera | California |
| United States | University of Wisconsin | Madison | Wisconsin |
| United States | Aurora St. Luke's Medical Center | Milwaukee | Wisconsin |
| United States | Children's Hospitals and Clinics of Minnesota | Minneapolis | Minnesota |
| United States | Yale New Haven Hospital | New Haven | Connecticut |
| United States | Cohen Children's Medical Center | New Hyde Park | New York |
| United States | Children's Hospital | New Orleans | Louisiana |
| United States | Children's Hospital of New York - Presbyterian | New York | New York |
| United States | Mount Sinai Hospital | New York | New York |
| United States | New York Presbyterian/Cornell | New York | New York |
| United States | Advocate Christ Medical Center | Oak Lawn | Illinois |
| United States | University of Oklahoma | Oklahoma City | Oklahoma |
| United States | Arnold Palmer Hospital for Children | Orlando | Florida |
| United States | Florida Hospital Orlando | Orlando | Florida |
| United States | Stanford University Medical Center | Palo Alto | California |
| United States | Huntington Memorial Hospital | Pasadena | California |
| United States | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania |
| United States | University of Pennslyvania | Philadelphia | Pennsylvania |
| United States | Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania |
| United States | St. Louis Children's Hospital | Saint Louis | Missouri |
| United States | All Children's Hospital | Saint Petersburg | Florida |
| United States | Primary Children's Hospital | Salt Lake City | Utah |
| United States | Rady Children's Hospital | San Diego | California |
| United States | Seattle Children's Hospital | Seattle | Washington |
| United States | University of Washington | Seattle | Washington |
| United States | Providence Medical Research Group | Spokane | Washington |
| United States | Tampa General Hospital | Tampa | Florida |
| United States | University of Arizona | Tucson | Arizona |
| United States | Children's National Medical Center | Washington | District of Columbia |
| United States | Iowa Heart Center / Mercy Medical Center | West Des Moines | Iowa |
| United States | Nemours/Alfred I. duPont Hospital for Children | Wilmington | Delaware |
| Lead Sponsor | Collaborator |
|---|---|
| Abbott Medical Devices |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Cumulative incidence of cardiac erosion | Cumulative incidence of erosion will be reported as: • The number of erosions per 8000 subjects. |
1 year | |
| Secondary | Aortic Rim Measurements (< 5 mm, = 5 mm) | 1 year | ||
| Secondary | Atrio-Ventricular (AV) Valve Rim Measurements (< 5 mm, = 5 mm) | 1 year | ||
| Secondary | Superior Vena Cava (SVC) Rim Measurements (< 5 mm, = 5 mm) | 1 year | ||
| Secondary | Inferior Vena Cava (IVC) Rim Measurements (< 5 mm, = 5 mm) | 1 year | ||
| Secondary | Other Evaluable Rim Measurements (< 5 mm, = 5 mm) | 1 year | ||
| Secondary | Ratio of Defect Size (Diameter) to Septal Length (< 0.5:1, = 0.5:1) | 1 year | ||
| Secondary | Ratio of Defect Size (Diameter) to Septal Width (< 0.5:1, = 0.5:1) | 1 year | ||
| Secondary | Device Splaying the Aorta (Yes, No) | 1 year | ||
| Secondary | Device Impingement of the Aorta (Yes, No) | 1 year | ||
| Secondary | Device Abutting the Aorta (Yes, No) | 1 year | ||
| Secondary | Age (< 14, = 14 years) | 1 year | ||
| Secondary | Gender (Male, Female) | 1 year | ||
| Secondary | Device Size Implanted (< 18 mm, = 18 mm) | 1 year | ||
| Secondary | Device Size to Defect Size (< 1.5:1, = 1.5:1) | 1 year | ||
| Secondary | Body Surface Area (<1.5 m2 and = 1.5m2) | 1 year |