AMPLATZER PFO Occluder Post Approval Study (PFO PAS)

OSB Lead-AMPLATZER PFO Occluder New Enrollment PAS

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Patent Foramen Ovale
• Intervention / Treatment: Device: AMPLATZER™ PFO Occluder

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.

• Study Type: Interventional
• Enrollment (Estimated): 1214
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maren Wagner; Phone Number: 651 756 5585; Email: maren.wagner@abbott.com

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 2T9
      • Active, not recruiting
      • Foothills Medical Centre
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • Enrolling by invitation
      • Vancouver General Hospital
  • Ontario
    • Toronto, Ontario, Canada, M5G 2C4
      • Enrolling by invitation
      • Toronto General Hospital
  • Quebec
    • Montréal, Quebec, Canada, H1T 1C8
      • Enrolling by invitation
      • Institut de Cardiologie de Montreal (Montreal Heart Inst.)
• Germany
  • Berlin, Germany, 13353
    • Enrolling by invitation
    • Deutsches Herzzentrum Berlin
  • Bavaria
    • München, Bavaria, Germany, 80636
      • Recruiting
      • Deutsches Herzzentrum München des Freistaates Bayern
      • Principal Investigator: Stanimir Georgiev, MD
• Italy
  • Lombard
    • Milano, Lombard, Italy
      • Enrolling by invitation
      • Centro Cardiologico Monzino
• Portugal
  • Lisbon
    • Lisboa, Lisbon, Portugal, 1649-035
      • Enrolling by invitation
      • Santa Maria Hospital
• Switzerland
  • Stgalln
    • Saint Gallen, Stgalln, Switzerland, 9007
      • Enrolling by invitation
      • Kantonsspital St.Gallen
• United Kingdom
  • London, United Kingdom, SE1 7EH
    • Enrolling by invitation
    • St. Thomas Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35249
      • Enrolling by invitation
      • University of Alabama at Birmingham
    • Huntsville, Alabama, United States, 35801
      • Enrolling by invitation
      • Heart Center Research, LLC
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Enrolling by invitation
      • Chandler Regional Medical Center
    • Phoenix, Arizona, United States, 85013
      • Active, not recruiting
      • St. Joseph's Hospital and Medical Center
    • Scottsdale, Arizona, United States, 85260
      • Active, not recruiting
      • Scottsdale Healthcare Shea
    • Tucson, Arizona, United States, 85712
      • Enrolling by invitation
      • Pima Heart Physicians, PC
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Completed
      • UAMS Medical Center
  • California
    • Los Angeles, California, United States, 90027
      • Enrolling by invitation
      • Kaiser Permanente Los Angeles Medical Center
    • Los Angeles, California, United States, 90033
      • Enrolling by invitation
      • USC University Hospital
    • Los Angeles, California, United States, 90095
      • Active, not recruiting
      • Ronald Reagan UCLA Medical Center
    • Sacramento, California, United States, 95816
      • Active, not recruiting
      • Sutter Medical Center
    • San Diego, California, United States, 92123
      • Enrolling by invitation
      • San Diego Cardiac Center
    • San Francisco, California, United States, 94143
      • Enrolling by invitation
      • University of California at San Francisco
    • Stanford, California, United States, 94305
      • Enrolling by invitation
      • Stanford University Medical Center
    • Thousand Oaks, California, United States, 91360
      • Active, not recruiting
      • Los Robles Hospital and Medical Center
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Enrolling by invitation
      • University of Colorado Hospital
    • Colorado Springs, Colorado, United States, 80909
      • Active, not recruiting
      • Memorial Hospital of Colorado Springs
    • Denver, Colorado, United States, 80031
      • Completed
      • Denver Heart
    • Littleton, Colorado, United States, 80120
      • Enrolling by invitation
      • South Denver Cardiology Associates PC
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Enrolling by invitation
      • Washington Hospital Center
  • Florida
    • Jacksonville, Florida, United States, 32204
      • Active, not recruiting
      • St. Vincent's Medical Center
    • Jacksonville, Florida, United States, 32207
      • Enrolling by invitation
      • Baptist Medical Center
    • Jacksonville, Florida, United States, 32256
      • Enrolling by invitation
      • First Coast Cardiovascular Institute
    • Miami, Florida, United States, 33176
      • Withdrawn
      • Baptist Hospital of Miami
    • Orlando, Florida, United States, 32806
      • Enrolling by invitation
      • Orlando Health
    • Weston, Florida, United States, 33331
      • Enrolling by invitation
      • Cleveland Clinic Florida
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Withdrawn
      • Emory University Hospital
    • Augusta, Georgia, United States, 30912
      • Active, not recruiting
      • Augusta University
    • Gainesville, Georgia, United States, 30501
      • Enrolling by invitation
      • Northeast Georgia Medical Center
    • Marietta, Georgia, United States, 98502
      • Enrolling by invitation
      • Wellstar Kennestone Hospital
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Enrolling by invitation
      • Rush University Medical Center
    • Springfield, Illinois, United States, 63146
      • Active, not recruiting
      • Prairie Education and Research Cooperative
  • Indiana
    • Indianapolis, Indiana, United States, 46240
      • Withdrawn
      • St. Vincent Hospital
  • Kansas
    • Overland Park, Kansas, United States, 66209
      • Enrolling by invitation
      • HCA Midwest Division, Menorah Medical Center
    • Wichita, Kansas, United States, 67214
      • Withdrawn
      • Cardiovascular Research Institute of Kansas
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • Active, not recruiting
      • University of Kentucky
    • Louisville, Kentucky, United States, 40515
      • Enrolling by invitation
      • Baptist Hospital East
  • Louisiana
    • New Orleans, Louisiana, United States, 70448
      • Active, not recruiting
      • Ochsner Medical Center
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Enrolling by invitation
      • Johns Hopkins University Hospital
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Enrolling by invitation
      • Tufts Medical Center
    • Fall River, Massachusetts, United States, 02720
      • Enrolling by invitation
      • Charlton Memorial Hospital
    • Worcester, Massachusetts, United States, 01655
      • Not yet recruiting
      • University of Massachusetts Medical Center
      • Principal Investigator: Vaikom Mahadevan, MD
  • Michigan
    • Auburn Hills, Michigan, United States, 48326
      • Enrolling by invitation
      • McLaren Health Care Corporation
    • Detroit, Michigan, United States, 48201
      • Completed
      • Children's Hospital of Michigan
    • Detroit, Michigan, United States, 48084
      • Enrolling by invitation
      • Henry Ford Hospital
    • Lansing, Michigan, United States, 48912
      • Enrolling by invitation
      • Sparrow Clinical Research Institute
  • Minnesota
    • Duluth, Minnesota, United States, 55805
      • Active, not recruiting
      • St. Mary's Hospital
    • Minneapolis, Minnesota, United States, 55407
      • Active, not recruiting
      • Minneapolis Heart Institute
    • Saint Cloud, Minnesota, United States, 56303
      • Enrolling by invitation
      • St. Cloud Hospital
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Enrolling by invitation
      • Washington University School of Medicine
    • Saint Louis, Missouri, United States, 63128
      • Enrolling by invitation
      • Mercy Hospital South
  • Montana
    • Missoula, Montana, United States, 59802
      • Active, not recruiting
      • St. Patrick Hospital
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • Enrolling by invitation
      • University of Nebraska Medical Center
  • New Jersey
    • Newark, New Jersey, United States, 07112
      • Enrolling by invitation
      • Newark Beth Israel Medical Center
  • New York
    • New York, New York, United States, 10019
      • Enrolling by invitation
      • Mount Sinai Hospital
    • New York, New York, United States, 10021
      • Enrolling by invitation
      • New York Presbyterian Hospital/ Cornell University
    • Stony Brook, New York, United States, 11790
      • Enrolling by invitation
      • Stony Brook University Medical Center
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Active, not recruiting
      • Novant Health Heart and Vascular Research
    • Greensboro, North Carolina, United States, 27358
      • Enrolling by invitation
      • Moses H Cone Memorial Hospital
    • Winston-Salem, North Carolina, United States, 27358
      • Enrolling by invitation
      • Forsyth Medical Center
  • Ohio
    • Cincinnati, Ohio, United States, 45236
      • Completed
      • Jewish Hospital
    • Cincinnati, Ohio, United States, 45242
      • Enrolling by invitation
      • TriHealth Bethesda North Hospital
    • Columbus, Ohio, United States, 43210
      • Active, not recruiting
      • Ohio Health Research Institute
    • Columbus, Ohio, United States, 43210
      • Enrolling by invitation
      • Ohio State University
    • Columbus, Ohio, United States, 43213
      • Enrolling by invitation
      • Mt Carmel East
  • Oregon
    • Clackamas, Oregon, United States, 97015
      • Enrolling by invitation
      • Kaiser Sunnyside Medical Center
    • Portland, Oregon, United States, 97225
      • Enrolling by invitation
      • Providence Heart and Vascular Institute
    • Portland, Oregon, United States, 97227
      • Withdrawn
      • Legacy Emanuel Hospital and Health Center
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822
      • Active, not recruiting
      • Geisinger Medical Center
    • Hershey, Pennsylvania, United States, 17033
      • Enrolling by invitation
      • Penn State Milton S Hershey Medical Center
    • Pittsburgh, Pennsylvania, United States, 15212
      • Enrolling by invitation
      • Allegheny Singer Research Institute
  • South Carolina
    • West Columbia, South Carolina, United States, 29169
      • Enrolling by invitation
      • Lexington Medical Center
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57117
      • Enrolling by invitation
      • Sanford USD Medical Center
  • Tennessee
    • Chattanooga, Tennessee, United States, 37922
      • Active, not recruiting
      • Erlanger Medical Center
    • Knoxville, Tennessee, United States, 37920
      • Active, not recruiting
      • Tennova Healthcare - Turkey Creek Medical Center
  • Texas
    • Austin, Texas, United States, 78705
      • Enrolling by invitation
      • Seton Medical Center
    • Houston, Texas, United States, 77004
      • Enrolling by invitation
      • Park Plaza Hospital
    • Houston, Texas, United States, 77074
      • Enrolling by invitation
      • University of Texas Health Science Center at Houston
    • Plano, Texas, United States, 75093
      • Enrolling by invitation
      • The Heart Hospital Baylor Plano
  • Virginia
    • Norfolk, Virginia, United States, 23112
      • Enrolling by invitation
      • Sentara Norfolk General Hospital
    • Virginia Beach, Virginia, United States, 23454
      • Withdrawn
      • Bayview Physicians Services, PC
  • Washington
    • Seattle, Washington, United States, 98195
      • Enrolling by invitation
      • University of Washington Medical Center
    • Seattle, Washington, United States, 98122
      • Active, not recruiting
      • Swedish Medical Center - Heart & Vascular
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • Enrolling by invitation
      • University of Wisconsin Hospital
    • Marshfield, Wisconsin, United States, 54449
      • Withdrawn
      • Marshfield Clinic
    • Milwaukee, Wisconsin, United States, 53226
      • Withdrawn
      • Medical College of Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • Enrolling by invitation
      • Aurora Medical Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Effectiveness: 5 year rate of recurrent ischemic stroke	5 year rate of recurrent ischemic stroke	Through 5 years
Primary Safety: Device or procedure related serious adverse events	Device or procedure related serious adverse events through 30 days	Through 30 days post implant

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Study Director: Barathi Sethuraman, PhD, Abbott

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2018
• Primary Completion (Estimated): October 31, 2024
• Study Completion (Estimated): April 30, 2030

Study Registration Dates

• First Submitted: October 10, 2017
• First Submitted That Met QC Criteria: October 12, 2017
• First Posted (Actual): October 13, 2017

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

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, Atrial; Heart Septal Defects; Foramen Ovale, Patent
• Other Study ID Numbers: SJM-CIP-10187

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No