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

Status: Terminated
Location: See all (65) locations...
Intervention Type: Device
Study Type: Observational
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.)

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: No
View:

• 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.)

Locations
United States
Alabama
University of Alabama
Birmingham
Arkansas
University of Arkansas
Little Rock
Arizona
University of Arizona
Tucson
California
Children's Hospital Los Angeles
Los Angeles
Kaiser Permanente Los Angeles Medical Center
Los Angeles
Ronald Reagan UCLA Medical Center
Los Angeles
University of Southern California
Los Angeles
Valley Children's Hospital
Madera
Stanford University Medical Center
Palo Alto
Huntington Memorial Hospital
Pasadena
Rady Children's Hospital
San Diego
Connecticut
Yale New Haven Hospital
New Haven
Washington, D.c.
Children's National Medical Center
Washington
Delaware
Nemours/Alfred I. duPont Hospital for Children
Wilmington
Florida
Clearwater Cardiovascular Consultants
Clearwater
Baptist Medical Center
Jacksonville
Arnold Palmer Hospital for Children
Orlando
Florida Hospital Orlando
Orlando
All Children's Hospital
Saint Petersburg
Tampa General Hospital
Tampa
Georgia
Children's Healthcare of Atlanta
Atlanta
Iowa
Iowa Heart Center / Mercy Medical Center
West Des Moines
Illinois
Advocate Christ Medical Center
Oak Lawn
Indiana
Riley Hospital for Children
Indianapolis
Louisiana
Children's Hospital
New Orleans
Massachusetts
Boston Children's Hospital
Boston
Maryland
University of Maryland
Baltimore
Michigan
Children's Hospital of Michigan
Detroit
Henry Ford Hospital
Detroit
Minnesota
Children's Hospitals and Clinics of Minnesota
Minneapolis
Missouri
St. Louis Children's Hospital
Saint Louis
Mississippi
University of Mississippi Medical Center
Jackson
North Carolina
University of North Carolina
Chapel Hill
Duke University Hospital
Durham
East Carolina University
Greenville
New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon
Nevada
Sunrise Hospital
Las Vegas
New York
Albany Medical College
Albany
Cohen Children's Medical Center
New Hyde Park
Children's Hospital of New York - Presbyterian
New York
Mount Sinai Hospital
New York
New York Presbyterian/Cornell
New York
Ohio
Cleveland Clinic Foundation
Cleveland
Nationwide Children's Hospital
Columbus
The Ohio State University
Columbus
Oklahoma
University of Oklahoma
Oklahoma City
Pennsylvania
Holy Spirit Hospital
Camp Hill
Geisinger Medical Center
Danville
Pinnacle Health
Harrisburg
Children's Hospital of Philadelphia
Philadelphia
University of Pennslyvania
Philadelphia
Children's Hospital of Pittsburgh
Pittsburgh
Texas
North Austin Medical Center
Austin
Driscoll Children's Hospital
Corpus Christi
Houston Methodist DeBakey Heart and Vascular Center
Houston
Texas Children's Hospital / Baylor College of Medicine
Houston
The University of Texas Health Science Center at Houston/Memorial Hermann Hospital
Houston
Utah
Primary Children's Hospital
Salt Lake City
Virginia
University of Virginia
Charlottesville
Inova Fairfax Hospital
Falls Church
Washington
Seattle Children's Hospital
Seattle
University of Washington
Seattle
Providence Medical Research Group
Spokane
Wisconsin
University of Wisconsin
Madison
Aurora St. Luke's Medical Center
Milwaukee
Time Frame
Start Date: January 19, 2015
Completion Date: February 24, 2017
Participants
Target number of participants: 602
Authors
Shabana Shahanavaz, Michael J Angtuaco, John Rhodes, Abraham Rothman, Jamil Aboulhosn, Wolfgang Radtke, Oluseun O. Alli, Frank F Ing, Marko Vezmar, Joseph A Paolillo, John Sullebarger, Joshua Kanter, David Nykanen, Charles Sperrazza, Robert English, John Robb, Jeremy Asnes, Morris M Salem, Daniel Turner, Richard W. Smalling, Mohammad El-Hajjar, Carl Garabedian, Michael Seckeler, Andreas Wali, Lynn Peng, Elman Frantz, C. Randolph Hubbard, Rohit Bhatheja, Jesse Esch, David J. Waight, Mark Hoyer, Makram Ebeid, Konstantinos Boudoulas, Azhil Durairaj, Muhammad Khan, Barry Love, James Thompson, Darren Berman, John W Moore, Robert Gray, Carl Owada, Saihari Sadanandan, Geoffrey Bergman, James Blankenship, Mark Tannenbaum, Michael Slack, Ernest Siwik, Richard Krasuski, Manish Chauhan, Asra Khan, Adam Greenbaum, Gary Stapleton, Jeffrey Delaney, Alexander Javois, Victor Lucas, C. Huie Lin, Kurt Jacobson, Thomas K Jones, Christopher Petit, Vivian Dimas, Patcharapong Suntharos, Jacqueline Kreutzer, Ray Matthews Matthews, Charles J Sang, G. Hamilton Baker, Alejandro Torres, Tanvir Bajwa, Matthew J Gillespie, Scott Lim, Howard Hermann
Sponsors
Leads: Abbott Medical Devices

This content was sourced from clinicaltrials.gov

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