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AMPLATZER PFO Occluder Post Approval Study (PFO PAS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03309332
Recruitment Status : Recruiting
First Posted : October 13, 2017
Last Update Posted : October 4, 2019
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Brief 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.

Condition or disease Intervention/treatment Phase
Stroke Patent Foramen Ovale Device: AMPLATZER™ PFO Occluder Not Applicable

Detailed Description:
A maximum of 1214 adult subjects will be enrolled at up to 100 centers in the U.S. and Canada. Subjects will have follow-up at 1 month, 6 months, 12 months and annually thereafter through 5 years post implant.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1214 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: OSB Lead-AMPLATZER PFO Occluder New Enrollment PAS
Actual Study Start Date : January 4, 2018
Estimated Primary Completion Date : December 2027
Estimated Study Completion Date : December 2027

Arm Intervention/treatment
Experimental: Device
Subjects implanted with the AMPLATZER™ PFO Occluder.
Device: AMPLATZER™ PFO Occluder
Implantation of the AMPLATZER™ PFO Occluder in the PFO




Primary Outcome Measures :
  1. Primary Effectiveness: 5 year rate of recurrent ischemic stroke [ Time Frame: Through 5 years ]
    5 year rate of recurrent ischemic stroke

  2. Primary Safety: Device or procedure related serious adverse events [ Time Frame: Through 30 days post implant ]
    Device or procedure related serious adverse events through 30 days



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Atherosclerosis or other arteriopathy of the intracranial and extracranial vessels associated with a ≥ 50% lumen diameter supplying the involved lesion
  • Intra-cardiac thrombus or tumor
  • Documented evidence of venous thrombus in the vessels through which access to the PFO is gained
  • Acute or recent (within 6 months prior to consent) myocardial infarction or unstable angina
  • Left ventricular aneurysm or akinesis
  • Mitral valve stenosis or severe mitral regurgitation requiring intervention irrespective of etiology
  • Aortic valve stenosis (mean gradient >40 mmHg) or severe aortic valve regurgitation
  • Mitral or aortic valve vegetation or prosthesis
  • Aortic arch plaques protruding greater than 4mm into the aortic lumen
  • Left ventricular dilated cardiomyopathy with depressed left ventricular ejection fraction (LVEF less than 35%)
  • Subjects with other source of right to left shunts, including an atrial septal defect and/or fenestrated septum
  • Chronic, persistent, or paroxysmal atrial fibrillation or atrial flutter
  • Pregnancy at the time of implant
  • Age less than 18 years or greater than 60 years at time of consent
  • Active endocarditis or other untreated infections
  • Organ failure (kidney, liver or lung) Kidney failure: Poor urine output of less than 1 cc/kg/hr with elevated BUN levels (above the normal reference range for the laboratory at the investigational site).

Liver failure: Liver enzymes outside the normal reference range for the laboratory at the investigational site: poor liver function as assessed by elevated PT (above the normal reference range for the laboratory at the investigational site) and low total protein and albumin (below the normal reference range for the laboratory at the investigational site).

Lung failure: Respiratory failure is retention of carbon dioxide more than 60 mmHg, poor oxygenation with oxygen tension less than 40 mmHg in room air or the need for assisted ventilation.

  • Uncontrolled hypertension defined as sustained elevated systemic blood pressure to more than 160/90 mmHg with medications
  • Uncontrolled diabetes defined as continued elevated glucose levels in spite of administration of insulin/levels of more than 200 mg with presence of glucose in the urine
  • Diagnosis of lacunar infarct probably due to intrinsic small vessel as qualifying stroke event Definition: Ischemic stroke in the distribution of a single, small deep penetrating vessel in a patient with any of the following: 1) a history of hypertension (except in the first week post stroke); 2) history of diabetes mellitus; 3) Age >/= 50; or 4) MRI or CT shows leukoaraiosis greater than symmetric, well-defined periventricular caps or bands (European Task Force on Age-Related White Matter Changes rating scale score > 0)
  • Arterial dissection as cause of stroke
  • Subjects who test positive with one of the following hypercoagulable states; Anticardiolipin Ab of the IgG or IgM (≥30), Lupus anticoagulant, B2-glycoprotein-1 antibodies (≥30) or persistently elevated homocysteine (>20)
  • Unable to take antiplatelet therapy
  • Anatomy in which the AMPLATZERTM PFO Occluder device size required would interfere with intracardiac or intravascular structures such as valves or pulmonary veins
  • Vasculature, through which access to the PFO is gained, is inadequate to accommodate the appropriate sheath size
  • Malignancy or other illness where life expectancy is less than 2 years
  • Subjects who will not be available for follow-up for the duration of the trial
  • Inability to obtain Informed Consent from patient
  • Index stroke of poor outcome (modified Rankin score greater than 3)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03309332


Contacts
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Contact: Maren Wagner 651 756 5585 mwagner2@sjm.com

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Locations
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United States, Arizona
Chandler Regional Medical Center Recruiting
Chandler, Arizona, United States, 85224
Principal Investigator: Nabil Dib, MD         
St. Joseph's Hospital and Medical Center Recruiting
Phoenix, Arizona, United States, 85013
Principal Investigator: Hursh Naik, MD         
Scottsdale Healthcare Shea Recruiting
Scottsdale, Arizona, United States, 85260
Principal Investigator: David Rizik, MD         
United States, California
Kaiser Permanente Los Angeles Medical Center Recruiting
Los Angeles, California, United States, 90027
Principal Investigator: Somjot Brar, MD, MPH         
USC University Hospital Recruiting
Los Angeles, California, United States, 90033
Principal Investigator: Ray V Matthews, MD         
Ronald Reagan UCLA Medical Center Recruiting
Los Angeles, California, United States, 90095
Principal Investigator: Jamil Aboulhosn, MD         
Sutter Medical Center Recruiting
Sacramento, California, United States, 95816
Principal Investigator: David Roberts, MD, FACC         
San Diego Cardiac Center Recruiting
San Diego, California, United States, 92123
Principal Investigator: Raghava Gollapudi, MD         
University of California at San Francisco Recruiting
San Francisco, California, United States, 94143
Principal Investigator: Vaikom Mahadevan, MD         
Stanford University Medical Center Recruiting
Stanford, California, United States, 94305
Principal Investigator: David Lee, MD         
Los Robles Hospital and Medical Center Recruiting
Thousand Oaks, California, United States, 91360
Principal Investigator: Vishva Dev, MD         
United States, Colorado
University of Colorado Hospital Recruiting
Aurora, Colorado, United States, 80045
Principal Investigator: Karen Orjuela, MD         
Memorial Hospital of Colorado Springs Recruiting
Colorado Springs, Colorado, United States, 80909
Principal Investigator: Cihan Cevik, MD         
Denver Heart Recruiting
Denver, Colorado, United States, 80031
Principal Investigator: Michael Wahl, MD         
South Denver Cardiology Associates PC Recruiting
Littleton, Colorado, United States, 80120
Principal Investigator: Lee MacDonald, MD         
United States, District of Columbia
Washington Hospital Center Recruiting
Washington, District of Columbia, United States, 20010
Principal Investigator: Lowell Satler, MD         
United States, Florida
St. Vincent's Medical Center Recruiting
Jacksonville, Florida, United States, 32204
Principal Investigator: Samer Garas, MD         
Baptist Medical Center Recruiting
Jacksonville, Florida, United States, 32207
Principal Investigator: Ruby Satpathy, MD         
First Coast Cardiobascular Institute Recruiting
Jacksonville, Florida, United States, 32256
Principal Investigator: Vaqar Ali, MD         
Orlando Health Recruiting
Orlando, Florida, United States, 32806
Principal Investigator: Vijay Kasi, PhD, MD         
Cleveland Clinic Florida Recruiting
Weston, Florida, United States, 33331
Principal Investigator: Roberto Cubbedu, MD         
United States, Georgia
Augusta University Recruiting
Augusta, Georgia, United States, 30912
Principal Investigator: Zahid Amin, MD         
WellStar Kennestone Hospital Recruiting
Marietta, Georgia, United States, 98502
Principal Investigator: Amar Patel, MD         
United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Principal Investigator: Clifford Kawinsky, MD         
Prairie Education and Research Cooperative Recruiting
Springfield, Illinois, United States, 63146
Principal Investigator: Nilesh Goswami, MD         
United States, Kansas
Cardiovascular Research Institute of Kansas Recruiting
Wichita, Kansas, United States, 67214
Principal Investigator: Bassem Chehab, MD         
United States, Kentucky
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40536
Principal Investigator: John Gurley, MD         
Baptist Hospital East Recruiting
Louisville, Kentucky, United States, 40515
Principal Investigator: Christopher Semder, MD         
United States, Louisiana
Ochsner Medical Center Recruiting
New Orleans, Louisiana, United States, 70448
Principal Investigator: James Jenkins, MD         
United States, Massachusetts
Tufts Medical Center Recruiting
Boston, Massachusetts, United States, 02111
Principal Investigator: David Thaler, MD         
Charlton Memorial Hospital Recruiting
Fall River, Massachusetts, United States, 02720
Principal Investigator: Adam Saltzman, MD         
United States, Michigan
McLaren Health Care Corporation Recruiting
Auburn Hills, Michigan, United States, 48326
Principal Investigator: Ahmad Munir, MD         
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48084
Principal Investigator: William O'Neill, MD         
Children's Hospital of Michigan Recruiting
Detroit, Michigan, United States, 48201
Principal Investigator: Thomas Forbes, MD         
Sparrow Clinical Research Institute Recruiting
Lansing, Michigan, United States, 48912
Contact: Nixon         
Principal Investigator: Gaurav Dhar, MD         
United States, Minnesota
St. Mary's Hospital Recruiting
Duluth, Minnesota, United States, 55805
Principal Investigator: Wilson Ginete, MD         
St. Cloud Hospital Recruiting
Saint Cloud, Minnesota, United States, 56303
Principal Investigator: Jacob Dutcher, MD         
United States, Missouri
HCA Midwest Division Recruiting
Lee's Summit, Missouri, United States, 64018
Principal Investigator: Bangalore Deepak, MD         
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Principal Investigator: Jin-Moo Lee, MD         
Mercy Hospital South Recruiting
Saint Louis, Missouri, United States, 63128
Principal Investigator: Edward Coverstone, MD         
United States, Montana
St. Patrick Hospital Recruiting
Missoula, Montana, United States, 59802
Principal Investigator: James Maddux, MD         
United States, Nebraska
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198
Principal Investigator: Jeffrey Delaney, MD         
United States, New Jersey
Newark Beth Israel Medical Center Recruiting
Newark, New Jersey, United States, 07112
Principal Investigator: Marc Cohen, MD         
United States, New York
New York Presbyterian Hospital/ Cornell University Recruiting
New York, New York, United States, 10021
Principal Investigator: Geoffrey Bergman, MBBS         
United States, North Carolina
Novant Health Heart and Vascular Research Recruiting
Charlotte, North Carolina, United States, 28204
Principal Investigator: Olseun Alli, MD         
Moses H Cone Memorial Hospital Recruiting
Greensboro, North Carolina, United States, 27358
Principal Investigator: Michael Cooper, MD         
Forsyth Medical Center Recruiting
Winston-Salem, North Carolina, United States, 27358
Principal Investigator: Samuel Turner, MD         
United States, Ohio
Jewish Hospital Recruiting
Cincinnati, Ohio, United States, 45236
Principal Investigator: Jonathan Rapp, MD         
Ohio Health Research Institute Recruiting
Columbus, Ohio, United States, 43210
Principal Investigator: Carlos Sanchez, MD         
Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Principal Investigator: Konstantinos Boudoulas, MD         
Mt Carmel East Recruiting
Columbus, Ohio, United States, 43213
Principal Investigator: Noah Jones, MD         
United States, Oregon
Kaiser Sunnyside Medical Center Recruiting
Clackamas, Oregon, United States, 97015
Principal Investigator: Abhimanyu Uberoi, MD         
Providence Heart and Vascular Institute Recruiting
Portland, Oregon, United States, 97225
Principal Investigator: Ethan Korngold, MD         
Legacy Emanuel Hospital and Health Center Recruiting
Portland, Oregon, United States, 97227
Principal Investigator: Amish Desai, MD         
United States, Pennsylvania
Geisinger Medical Center Recruiting
Danville, Pennsylvania, United States, 17822
Principal Investigator: James Blankenship, MD         
Penn State Milton S Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
Principal Investigator: Mark Kozak, MD         
Allegheny Singer Research Institute Recruiting
Pittsburgh, Pennsylvania, United States, 15212
Principal Investigator: David Lasorda, MD         
United States, South Carolina
Lexington Medical Center Recruiting
West Columbia, South Carolina, United States, 29169
Principal Investigator: Robert Leonardi, MD         
United States, South Dakota
Sanford USD Medical Center Recruiting
Sioux Falls, South Dakota, United States, 57117
Principal Investigator: Tomasz Stys, MD         
United States, Tennessee
Seton Medical Center Recruiting
Austin, Tennessee, United States, 78705
Principal Investigator: Matthew Stahlman, MD         
Erlanger Medical Center Recruiting
Chattanooga, Tennessee, United States, 37922
Principal Investigator: Matthew Wiisanen, MD         
East Tennessee Heart Consultants Recruiting
Knoxville, Tennessee, United States, 37920
Principal Investigator: Malcolm Foster, MD         
United States, Texas
University of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77074
Principal Investigator: Richard Smalling, MD         
The Heart Hospital Baylor Plano Recruiting
Plano, Texas, United States, 75093
Principal Investigator: Srinivasa Potluri, MD         
United States, Virginia
Sentara Norfolk General Hospital Recruiting
Norfolk, Virginia, United States, 23112
Principal Investigator: Paul Mahoney, MD         
Bayview Physicians Services, PC Recruiting
Virginia Beach, Virginia, United States, 23454
Principal Investigator: Deepak Talreja, MD, FACC, FSCAI         
United States, Washington
Swedish Medical Center - Heart & Vascular Recruiting
Seattle, Washington, United States, 98122
Principal Investigator: Sameer Gafoor, MD         
University of Washington Medical Center Recruiting
Seattle, Washington, United States, 98195
Principal Investigator: David L Tirschwell, MD         
United States, Wisconsin
University of Wisconsin Hospital Recruiting
Madison, Wisconsin, United States, 53792
Principal Investigator: Kurt Jacobson, MD         
Aurora Medical Group Recruiting
Milwaukee, Wisconsin, United States, 53215
Principal Investigator: Tanvir Bajwa, MD         
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Principal Investigator: David Marks, MD         
Canada, Alberta
Foothills Medical Centre Recruiting
Calgary, Alberta, Canada, T2N 2T9
Principal Investigator: Anna Bizios         
Canada, British Columbia
Vancouver General Hospital Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Principal Investigator: David Wood, MD         
Sponsors and Collaborators
Abbott Medical Devices
Investigators
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Study Director: Barathi Sethuraman, PhD Abbott

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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT03309332     History of Changes
Other Study ID Numbers: SJM-CIP-10187
First Posted: October 13, 2017    Key Record Dates
Last Update Posted: October 4, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Foramen Ovale, Patent
Heart Septal Defects, Atrial
Heart Septal Defects
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities