ADVANCE ASO AMPLATZER™ Atrial Septal Occluder Post Market Surveillance Study (ASO 522)

Closure of Atrial Septal Defects With the AMPLATZER™ Septal Occluder (ASO) Post Market Surveillance Study

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.)

Study Overview

• Status: Terminated
• Conditions: Atrial Septal Defect Secundum
• Intervention / Treatment: Device: atrial septal occluder

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 Type: Observational
• Enrollment (Actual): 602

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama
  • Arizona
    • Tucson, Arizona, United States, 85724
      • University of Arizona
  • Arkansas
    • Little Rock, Arkansas, United States, 72202
      • University of Arkansas
  • California
    • Los Angeles, California, United States, 90033
      • University of Southern California
    • Los Angeles, California, United States, 90027
      • Children's Hospital Los Angeles
    • Los Angeles, California, United States, 90027
      • Kaiser Permanente Los Angeles Medical Center
    • Los Angeles, California, United States, 90095
      • Ronald Reagan UCLA Medical Center
    • Madera, California, United States, 93636
      • Valley Children's Hospital
    • Palo Alto, California, United States, 94304
      • Stanford University Medical Center
    • Pasadena, California, United States, 91105
      • Huntington Memorial Hospital
    • San Diego, California, United States, 92123
      • Rady Children's Hospital
  • Connecticut
    • New Haven, Connecticut, United States, 06504
      • Yale New Haven Hospital
  • Delaware
    • Wilmington, Delaware, United States, 19803
      • Nemours/Alfred I. DuPont Hospital for Children
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Children's National Medical Center
  • Florida
    • Clearwater, Florida, United States, 33756
      • Clearwater Cardiovascular Consultants
    • Jacksonville, Florida, United States, 32207
      • Baptist Medical Center
    • Orlando, Florida, United States, 32803
      • Florida Hospital Orlando
    • Orlando, Florida, United States, 32806
      • Arnold Palmer Hospital for Children
    • Saint Petersburg, Florida, United States, 33701
      • All Children's Hospital
    • Tampa, Florida, United States, 33609
      • Tampa General Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Children's Healthcare of Atlanta
  • Illinois
    • Oak Lawn, Illinois, United States, 60453
      • Advocate Christ Medical Center
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Riley Hospital for Children
  • Iowa
    • West Des Moines, Iowa, United States, 50266
      • Iowa Heart Center / Mercy Medical Center
  • Louisiana
    • New Orleans, Louisiana, United States, 70118
      • Children's Hospital
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Boston Children's Hospital
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
    • Detroit, Michigan, United States, 48201
      • Children's Hospital of Michigan
  • Minnesota
    • Minneapolis, Minnesota, United States, 55404
      • Children's Hospitals and Clinics of Minnesota
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • University of Mississippi Medical Center
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • St. Louis Children's Hospital
  • Nevada
    • Las Vegas, Nevada, United States, 89109
      • Sunrise Hospital
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth Hitchcock Medical Center
  • New York
    • Albany, New York, United States, 12208
      • Albany Medical College
    • New Hyde Park, New York, United States, 11040
      • Cohen Children's Medical Center
    • New York, New York, United States, 10029
      • Mount Sinai Hospital
    • New York, New York, United States, 10021
      • New York Presbyterian/Cornell
    • New York, New York, United States, 10032
      • Children's Hospital of New York - Presbyterian
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Hospital
    • Greenville, North Carolina, United States, 27834
      • East Carolina University
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation
    • Columbus, Ohio, United States, 43205
      • Nationwide Children's Hospital
    • Columbus, Ohio, United States, 43210
      • The Ohio State University
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma
  • Pennsylvania
    • Camp Hill, Pennsylvania, United States, 17011
      • Holy Spirit Hospital
    • Danville, Pennsylvania, United States, 17822
      • Geisinger Medical Center
    • Harrisburg, Pennsylvania, United States, 17101
      • Pinnacle Health
    • Philadelphia, Pennsylvania, United States, 19104
      • Children's Hospital of Philadelphia
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennslyvania
    • Pittsburgh, Pennsylvania, United States, 15224
      • Children's Hospital of Pittsburgh
  • Texas
    • Austin, Texas, United States, 78758
      • North Austin Medical Center
    • Corpus Christi, Texas, United States, 78411
      • Driscoll Children's Hospital
    • Houston, Texas, United States, 77030
      • Texas Children's Hospital / Baylor College of Medicine
    • Houston, Texas, United States, 77030
      • Houston Methodist DeBakey Heart and Vascular Center
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston/Memorial Hermann Hospital
  • Utah
    • Salt Lake City, Utah, United States, 84113
      • Primary Children's Hospital
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia
    • Falls Church, Virginia, United States, 22042
      • Inova Fairfax Hospital
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington
    • Seattle, Washington, United States, 98105
      • Seattle Children's Hospital
    • Spokane, Washington, United States, 99204
      • Providence Medical Research Group
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • Aurora St. Luke's Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative incidence of cardiac erosion	Cumulative incidence of erosion will be reported as: • The number of erosions per 8000 subjects.	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Aortic Rim Measurements (< 5 mm, ≥ 5 mm)	1 year
Atrio-Ventricular (AV) Valve Rim Measurements (< 5 mm, ≥ 5 mm)	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
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 Splaying the Aorta (Yes, No)	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
Gender (Male, Female)	1 year
Device Size Implanted (< 18 mm, ≥ 18 mm)	1 year
Device Size to Defect Size (< 1.5:1, ≥ 1.5:1)	1 year
Body Surface Area (<1.5 m2 and ≥ 1.5m2)	1 year

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Study Director: Ashish Oza, Abbott Medical Devices

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2015
• Primary Completion (Actual): February 24, 2017
• Study Completion (Actual): February 24, 2017

Study Registration Dates

• First Submitted: December 2, 2014
• First Submitted That Met QC Criteria: January 28, 2015
• First Posted (Estimate): February 2, 2015

Study Record Updates

• Last Update Posted (Actual): February 4, 2019
• Last Update Submitted That Met QC Criteria: January 31, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Heart Defects, Congenital; Cardiovascular Abnormalities; Heart Septal Defects; Heart Septal Defects, Atrial
• Other Study ID Numbers: PS130046