Clinical trial NCT02353351: ADVANCE ASO AMPLATZER™ Atrial Septal Occluder Post Market Surveillance Study
Official title: Closure of Atrial Septal Defects With the AMPLATZER™ Septal Occluder (ASO) Post Market Surveillance Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Atrial Septal Defect Secundum
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2015-02-02
Enrollment: 602
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients indicated for ASD closure have 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).

The subject population includes vulnerable patients.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cumulative incidence of cardiac erosion
timeFrame: 1 year
Secondary outcomes:
measure: Aortic Rim Measurements (< 5 mm, ≥ 5 mm)
timeFrame: 1 year
measure: Atrio-Ventricular (AV) Valve Rim Measurements (< 5 mm, ≥ 5 mm)
timeFrame: 1 year
measure: Superior Vena Cava (SVC) Rim Measurements (< 5 mm, ≥ 5 mm)
timeFrame: 1 year
measure: Inferior Vena Cava (IVC) Rim Measurements (< 5 mm, ≥ 5 mm)
timeFrame: 1 year
measure: Other Evaluable Rim Measurements (< 5 mm, ≥ 5 mm)
timeFrame: 1 year
measure: Ratio of Defect Size (Diameter) to Septal Length (< 0.5:1, ≥ 0.5:1)
timeFrame: 1 year
measure: Ratio of Defect Size (Diameter) to Septal Width (< 0.5:1, ≥ 0.5:1)
timeFrame: 1 year
measure: Device Splaying the Aorta (Yes, No)
timeFrame: 1 year
measure: Device Impingement of the Aorta (Yes, No)
timeFrame: 1 year
measure: Device Abutting the Aorta (Yes, No)
timeFrame: 1 year
measure: Age (< 14, ≥ 14 years)
timeFrame: 1 year
measure: Gender (Male, Female)
timeFrame: 1 year
measure: Device Size Implanted (< 18 mm, ≥ 18 mm)
timeFrame: 1 year
measure: Device Size to Defect Size (< 1.5:1, ≥ 1.5:1)
timeFrame: 1 year
measure: Body Surface Area (<1.5 m2 and ≥ 1.5m2)
timeFrame: 1 year
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: Little Rock
country: United States
facility: University of Arkansas
state: Arkansas
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
city: Los Angeles
country: United States
facility: Kaiser Permanente Los Angeles Medical Center
state: California
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Los Angeles
country: United States
facility: Ronald Reagan UCLA Medical Center
state: California
city: Madera
country: United States
facility: Valley Children's Hospital
state: California
city: Palo Alto
country: United States
facility: Stanford University Medical Center
state: California
city: Pasadena
country: United States
facility: Huntington Memorial Hospital
state: California
city: San Diego
country: United States
facility: Rady Children's Hospital
state: California
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: Wilmington
country: United States
facility: Nemours/Alfred I. duPont Hospital for Children
state: Delaware
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Clearwater
country: United States
facility: Clearwater Cardiovascular Consultants
state: Florida
city: Jacksonville
country: United States
facility: Baptist Medical Center
state: Florida
city: Orlando
country: United States
facility: Florida Hospital Orlando
state: Florida
city: Orlando
country: United States
facility: Arnold Palmer Hospital for Children
state: Florida
city: Saint Petersburg
country: United States
facility: All Children's Hospital
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
city: Oak Lawn
country: United States
facility: Advocate Christ Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: Riley Hospital for Children
state: Indiana
city: West Des Moines
country: United States
facility: Iowa Heart Center / Mercy Medical Center
state: Iowa
city: New Orleans
country: United States
facility: Children's Hospital
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Detroit
country: United States
facility: Children's Hospital of Michigan
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Minneapolis
country: United States
facility: Children's Hospitals and Clinics of Minnesota
state: Minnesota
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Saint Louis
country: United States
facility: St. Louis Children's Hospital
state: Missouri
city: Las Vegas
country: United States
facility: Sunrise Hospital
state: Nevada
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: Albany
country: United States
facility: Albany Medical College
state: New York
city: New Hyde Park
country: United States
facility: Cohen Children's Medical Center
state: New York
city: New York
country: United States
facility: New York Presbyterian/Cornell
state: New York
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: New York
country: United States
facility: Children's Hospital of New York - Presbyterian
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Durham
country: United States
facility: Duke University Hospital
state: North Carolina
city: Greenville
country: United States
facility: East Carolina University
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma
state: Oklahoma
city: Camp Hill
country: United States
facility: Holy Spirit Hospital
state: Pennsylvania
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Harrisburg
country: United States
facility: Pinnacle Health
state: Pennsylvania
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennslyvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh
state: Pennsylvania
city: Austin
country: United States
facility: North Austin Medical Center
state: Texas
city: Corpus Christi
country: United States
facility: Driscoll Children's Hospital
state: Texas
city: Houston
country: United States
facility: Houston Methodist DeBakey Heart and Vascular Center
state: Texas
city: Houston
country: United States
facility: Texas Children's Hospital / Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston/Memorial Hermann Hospital
state: Texas
city: Salt Lake City
country: United States
facility: Primary Children's Hospital
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Falls Church
country: United States
facility: Inova Fairfax Hospital
state: Virginia
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Spokane
country: United States
facility: Providence Medical Research Group
state: Washington
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
city: Milwaukee
country: United States
facility: Aurora St. Luke's Medical Center
state: Wisconsin
Study officials:
affiliation: Abbott Medical Devices
name: Ashish Oza
role: STUDY_DIRECTOR
References: