OSB Lead-AMPLATZER PFO Occluder New Enrollment PAS

Status: Recruiting
Location: See all (90) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The purpose of this single arm, multi-center study is to confirm the safety and effectiveness of the AMPLATZER™ PFO Occluder in the post Approval Setting.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: No
View:

• • Subjects with a PFO who have had an ischemic stroke within the last 547 days

Locations
United States
Alabama
University of Alabama at Birmingham
Enrolling by invitation
Birmingham
Heart Center Research, LLC
Enrolling by invitation
Huntsville
Arkansas
UAMS Medical Center
Recruiting
Little Rock
Arizona
Chandler Regional Medical Center
Enrolling by invitation
Chandler
St. Joseph's Hospital and Medical Center
Active, not recruiting
Phoenix
Scottsdale Healthcare Shea
Enrolling by invitation
Scottsdale
Pima Heart Physicians, PC
Enrolling by invitation
Tucson
California
Kaiser Permanente Los Angeles Medical Center
Enrolling by invitation
Los Angeles
Ronald Reagan UCLA Medical Center
Enrolling by invitation
Los Angeles
USC University Hospital
Enrolling by invitation
Los Angeles
Sutter Medical Center
Active, not recruiting
Sacramento
San Diego Cardiac Center
Enrolling by invitation
San Diego
University of California at San Francisco
Enrolling by invitation
San Francisco
Stanford University Medical Center
Enrolling by invitation
Stanford
Los Robles Hospital and Medical Center
Enrolling by invitation
Thousand Oaks
Colorado
University of Colorado Hospital
Enrolling by invitation
Aurora
Memorial Hospital of Colorado Springs
Enrolling by invitation
Colorado Springs
Denver Heart
Enrolling by invitation
Denver
South Denver Cardiology Associates PC
Enrolling by invitation
Littleton
Washington, D.c.
Washington Hospital Center
Enrolling by invitation
Washington
Florida
Baptist Medical Center
Enrolling by invitation
Jacksonville
First Coast Cardiovascular Institute
Enrolling by invitation
Jacksonville
St. Vincent's Medical Center
Enrolling by invitation
Jacksonville
Baptist Hospital of Miami
Withdrawn
Miami
Orlando Health
Enrolling by invitation
Orlando
Cleveland Clinic Florida
Enrolling by invitation
Weston
Georgia
Emory University Hospital
Withdrawn
Atlanta
Augusta University
Active, not recruiting
Augusta
Northeast Georgia Medical Center
Enrolling by invitation
Gainesville
WellStar Kennestone Hospital
Enrolling by invitation
Marietta
Illinois
Rush University Medical Center
Enrolling by invitation
Chicago
Prairie Education and Research Cooperative
Active, not recruiting
Springfield
Indiana
St. Vincent Hospital
Withdrawn
Indianapolis
Kansas
HCA Midwest Division, Menorah Medical Center
Enrolling by invitation
Overland Park
Cardiovascular Research Institute of Kansas
Withdrawn
Wichita
Kentucky
University of Kentucky
Enrolling by invitation
Lexington
Baptist Hospital East
Enrolling by invitation
Louisville
Louisiana
Ochsner Medical Center
Active, not recruiting
New Orleans
Massachusetts
Tufts Medical Center
Enrolling by invitation
Boston
Charlton Memorial Hospital
Enrolling by invitation
Fall River
Maryland
Johns Hopkins University Hospital
Enrolling by invitation
Baltimore
Michigan
McLaren Health Care Corporation
Enrolling by invitation
Auburn Hills
Children's Hospital of Michigan
Completed
Detroit
Henry Ford Hospital
Enrolling by invitation
Detroit
Sparrow Clinical Research Institute
Enrolling by invitation
Lansing
Minnesota
St. Mary's Hospital
Enrolling by invitation
Duluth
Minneapolis Heart Institute
Enrolling by invitation
Minneapolis
St. Cloud Hospital
Enrolling by invitation
Saint Cloud
Missouri
Mercy Hospital South
Enrolling by invitation
Saint Louis
Washington University School of Medicine
Enrolling by invitation
Saint Louis
Montana
St. Patrick Hospital
Active, not recruiting
Missoula
North Carolina
Novant Health Heart and Vascular Research
Enrolling by invitation
Charlotte
Moses H Cone Memorial Hospital
Enrolling by invitation
Greensboro
Forsyth Medical Center
Enrolling by invitation
Winston-salem
Nebraska
University of Nebraska Medical Center
Enrolling by invitation
Omaha
New Jersey
Newark Beth Israel Medical Center
Enrolling by invitation
Newark
New York
Mount Sinai Hospital
Enrolling by invitation
New York
New York Presbyterian Hospital/ Cornell University
Enrolling by invitation
New York
Stony Brook University Medical Center
Enrolling by invitation
Stony Brook
Ohio
Jewish Hospital
Completed
Cincinnati
TriHealth Bethesda North Hospital
Not yet recruiting
Cincinnati
Mt Carmel East
Enrolling by invitation
Columbus
Ohio Health Research Institute
Active, not recruiting
Columbus
Ohio State University
Enrolling by invitation
Columbus
Oregon
Kaiser Sunnyside Medical Center
Enrolling by invitation
Clackamas
Legacy Emanuel Hospital and Health Center
Withdrawn
Portland
Providence Heart and Vascular Institute
Enrolling by invitation
Portland
Pennsylvania
Geisinger Medical Center
Active, not recruiting
Danville
Penn State Milton S Hershey Medical Center
Enrolling by invitation
Hershey
Allegheny Singer Research Institute
Enrolling by invitation
Pittsburgh
South Carolina
Lexington Medical Center
Enrolling by invitation
West Columbia
South Dakota
Sanford USD Medical Center
Enrolling by invitation
Sioux Falls
Tennessee
Erlanger Medical Center
Active, not recruiting
Chattanooga
Tennova Healthcare - Turkey Creek Medical Center
Enrolling by invitation
Knoxville
Texas
Seton Medical Center
Enrolling by invitation
Austin
Park Plaza Hospital
Enrolling by invitation
Houston
University of Texas Health Science Center at Houston
Enrolling by invitation
Houston
The Heart Hospital Baylor Plano
Enrolling by invitation
Plano
Virginia
Sentara Norfolk General Hospital
Enrolling by invitation
Norfolk
Bayview Physicians Services, PC
Withdrawn
Virginia Beach
Washington
Swedish Medical Center - Heart & Vascular
Active, not recruiting
Seattle
University of Washington Medical Center
Enrolling by invitation
Seattle
Wisconsin
University of Wisconsin Hospital
Enrolling by invitation
Madison
Marshfield Clinic
Withdrawn
Marshfield
Aurora Medical Group
Enrolling by invitation
Milwaukee
Medical College of Wisconsin
Withdrawn
Milwaukee
Other Locations
Canada
Foothills Medical Centre
Enrolling by invitation
Calgary
Institut de Cardiologie de Montreal (Montreal Heart Inst.)
Enrolling by invitation
Montréal
Toronto General Hospital
Enrolling by invitation
Toronto
Vancouver General Hospital
Enrolling by invitation
Vancouver
Contact Information
Primary
Maren Wagner
maren.wagner@abbott.com
651 756 5585
Time Frame
Start Date: January 31, 2018
Estimated Completion Date: April 30, 2030
Participants
Target number of participants: 1214
Treatments
Experimental: Device
Subjects implanted with the AMPLATZER™ PFO Occluder.
Authors
Sponsors
Leads: Abbott Medical Devices

This content was sourced from clinicaltrials.gov

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