230
Participants
Start Date
January 31, 2006
Primary Completion Date
February 28, 2015
Study Completion Date
December 31, 2015
Sham Procedure
Will not receive the closure device, and will be treated with the current standard of care medical treatment. Will undergo Intracardiac Echo (ICE) in cardiac catheterization lab and simulate PFO closure procedure (sham procedure). Participants completing 1 year follow-up are eligible for PFO closure with the AMPLATZER PFO Occluder.
AMPLATZER PFO Occluder
Patients in this arm will receive the AMPLATZER PFO Occluder device
Mercy Hospital of Buffalo, Buffalo
Pinnacle Health Hospitals, Harrisburg
Thomas Jefferson University, Philadelphia
Washington Hospital Center, Washington D.C.
Inova Healthcare Services, Falls Church
University of Kentucky, Lexington
William Beaumont Hospital, Royal Oak
University of Iowa, Iowa City
St. Luke's Medical Center, Milwaukee
Medical College of Wisconsin, Milwaukee
Abbott Northwestern Hospital, Minneapolis
Mayo Clinic, Rochester
St. Cloud Hospital, Saint Cloud
Washington University School of Medicine, St Louis
St. Johns's Mercy Medical Center, St Louis
Alegent Health Bergan Mercy Medical Center, Omaha
Ochsner Clinic Foundation, New Orleans
The Methodist Hospital, Houston
Swedish Medical Center, Englewood
Medical Center of the Rockies, Fort Collins
Memorial Hospital, Colorado Springs
St. Mark's Hospital, Salt Lake City
Intermountain Medical Center, Salt Lake City
St. Joseph's Hospital & Medical Center, Phoenix
Children's Heart Center Las Vegas, Las Vegas
UCLA School of Medicine, Los Angeles
University of Washington Medical Center, Seattle
Tufts Medical Center, Boston
Massachusetts General Hospital, Boston
University of Rochester Medical School, Rochester
Lead Sponsor
Abbott Medical Devices
INDUSTRY