StrokePFO PASNCT03309332
AMPLATZER PFO Occluder Post Approval Study
A study testing AMPLATZER™ PFO Occluder in people with Stroke and Patent Foramen Ovale, run by Abbott Medical Devices at 88 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Stroke, Patent Foramen Ovale
- What is being tested?
- AMPLATZER™ PFO Occluder
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,214 participants
- Where
- 88 sitesin 7 countries
- Study dates
- 31 Jan 2018to 5 Feb 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects with a PFO who have had an ischemic stroke within the last 547 days
Who cannot join
- 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
Show all 28Show fewer
- 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)
Trial locations and contacts
88 sites in 7 countries.
88 sites in 7 countries
United States78 sites
McLaren Health Care Corporation
Auburn Hills, Michigan, 48326
Augusta University
Augusta, Georgia, 30912
University of Colorado Hospital
Aurora, Colorado, 80045
Ascension Texas Cardiovascular Research
Austin, Texas, 78705
Johns Hopkins University Hospital
Baltimore, Maryland, 21287
University of Alabama at Birmingham
Birmingham, Alabama, 35249
Tufts Medical Center
Boston, Massachusetts, 02111
Chandler Regional Medical Center
Chandler, Arizona, 85224
Novant Health Heart and Vascular Research
Charlotte, North Carolina, 28204
Erlanger Medical Center
Chattanooga, Tennessee, 37922
Rush University Medical Center
Chicago, Illinois, 60612
Jewish Hospital
Cincinnati, Ohio, 45236
TriHealth Bethesda North Hospital
Cincinnati, Ohio, 45242
Kaiser Sunnyside Medical Center
Clackamas, Oregon, 97015
Memorial Hospital of Colorado Springs
Colorado Springs, Colorado, 80909
Ohio Health Research Institute
Columbus, Ohio, 43210
Ohio State University
Columbus, Ohio, 43210
Mt Carmel East
Columbus, Ohio, 43213
Geisinger Medical Center
Danville, Pennsylvania, 17822
Denver Heart
Denver, Colorado, 80031
Henry Ford Hospital
Detroit, Michigan, 48084
Children's Hospital of Michigan
Detroit, Michigan, 48201
St. Mary's Hospital
Duluth, Minnesota, 55805
Charlton Memorial Hospital
Fall River, Massachusetts, 02720
Northeast Georgia Medical Center
Gainesville, Georgia, 30501
Moses H Cone Memorial Hospital
Greensboro, North Carolina, 27358
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033
HCA Houston Healthcare Medical Center
Houston, Texas, 77004
University of Texas Health Science Center at Houston
Houston, Texas, 77074
Heart Center Research, LLC
Huntsville, Alabama, 35801
St. Vincent's Medical Center
Jacksonville, Florida, 32204
Baptist Medical Center
Jacksonville, Florida, 32207
First Coast Cardiovascular Institute
Jacksonville, Florida, 32256
Tennova Healthcare - Turkey Creek Medical Center
Knoxville, Tennessee, 37920
Sparrow Clinical Research Institute
Lansing, Michigan, 48912
University of Kentucky
Lexington, Kentucky, 40536
UAMS Medical Center
Little Rock, Arkansas, 72205
South Denver Cardiology Associates PC
Littleton, Colorado, 80120
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027
USC University Hospital
Los Angeles, California, 90033
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095
Baptist Hospital East
Louisville, Kentucky, 40515
University of Wisconsin Hospital
Madison, Wisconsin, 53792
WellStar Kennestone Hospital
Marietta, Georgia, 98502
Aurora Medical Group
Milwaukee, Wisconsin, 53215
Minneapolis Heart Institute
Minneapolis, Minnesota, 55407
Providence St. Patrick Hospital
Missoula, Montana, 59802
Ochsner Medical Center
New Orleans, Louisiana, 70448
Mount Sinai Hospital
New York, New York, 10019
New York Presbyterian Hospital/ Cornell University
New York, New York, 10021
Newark Beth Israel Medical Center
Newark, New Jersey, 07112
Sentara Norfolk General Hospital
Norfolk, Virginia, 23112
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Orlando Health
Orlando, Florida, 32806
HCA Midwest Division, Menorah Medical Center
Overland Park, Kansas, 66209
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013
Allegheny General Hospital - ASRI
Pittsburgh, Pennsylvania, 15212
Baylor Scott & White - The Heart Hospital Baylor Plano
Plano, Texas, 75093
Providence Heart and Vascular Institute
Portland, Oregon, 97225
Sutter Medical Center
Sacramento, California, 95816
St. Cloud Hospital
Saint Cloud, Minnesota, 56303
San Diego Cardiac Center
San Diego, California, 92123
University of California at San Francisco
San Francisco, California, 94143
Scottsdale Healthcare Shea
Scottsdale, Arizona, 85260
Swedish Medical Center - Heart & Vascular
Seattle, Washington, 98122
University of Washington Medical Center
Seattle, Washington, 98195
Sanford USD Medical Center
Sioux Falls, South Dakota, 57117
Prairie Education and Research Cooperative
Springfield, Illinois, 63146
Washington University School of Medicine
St Louis, Missouri, 63110
Mercy Hospital South
St Louis, Missouri, 63128
Stanford University Medical Center
Stanford, California, 94305
Stony Brook University Medical Center
Stony Brook, New York, 11790
Los Robles Hospital and Medical Center
Thousand Oaks, California, 91360
Pima Heart Physicians, PC
Tucson, Arizona, 85712
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
Lexington Medical Center
West Columbia, South Carolina, 29169
Cleveland Clinic Florida
Weston, Florida, 33331
Forsyth Medical Center
Winston-Salem, North Carolina, 27358
Canada4 sites
Foothills Medical Centre
Calgary, Alberta, T2N 2T9
Institut de Cardiologie de Montreal (Montreal Heart Inst.)
Montreal, Quebec, H1T 1C8
Toronto General Hospital
Toronto, Ontario, M5G 2C4
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9
Germany2 sites
Deutsches Herzzentrum Berlin
Berlin, State of Berlin, 13353
TUM Klinikum - Deutsches Herzzentrum München
München, Bavaria, 80636
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke, Patent Foramen Ovale
- Being tested
- AMPLATZER™ PFO Occluder
- Medical subject headings
- Stroke, Foramen Ovale, Patent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMPLATZER™ PFO OccluderDevice
Implantation of the AMPLATZER™ PFO Occluder in the PFO
| Study group | Role | What they receive |
|---|---|---|
| Device | Experimental | Subjects implanted with the AMPLATZER™ PFO Occluder. Receives: Device: AMPLATZER™ PFO Occluder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Effectiveness: 5 year rate of recurrent ischemic stroke
5 year rate of recurrent ischemic stroke
Measured: Through 5 years
Primary Safety: Device or procedure related serious adverse events
Device or procedure related serious adverse events through 30 days
Measured: Through 30 days post implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2017
- Study start31 Jan 2018
- Primary completion5 Feb 2030 (estimated)
- Study completion5 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,214 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Barathi Sethuraman, PhD, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03309332
- Sponsor's protocol ID
- SJM-CIP-10187
- Acronym
- PFO PAS
- Status last verified
- Jan 2026
- First submitted
- 10 Oct 2017
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OSB Lead-AMPLATZER PFO Occluder New Enrollment PAS
- ClinicalTrials.gov ID
- NCT03309332
- Acronym / sponsor ID
- PFO PAS / SJM-CIP-10187
- Conditions
- Stroke, Patent Foramen Ovale
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,214 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 31 Jan 2018 (actual)
- Primary completion
- 5 Feb 2030 (estimated)
- Study completion
- 5 Feb 2030 (estimated)
- First posted
- 13 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device | Experimental | Device: AMPLATZER™ PFO OccluderSubjects implanted with the AMPLATZER™ PFO Occluder. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Subjects with a PFO who have had an ischemic stroke within the last 547 days
Key exclusion criteria (28 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AMPLATZER™ PFO OccluderImplantation of the AMPLATZER™ PFO Occluder in the PFO | Device | Device |
Primary outcome
Primary Effectiveness: 5 year rate of recurrent ischemic stroke
Time frame: Through 5 years
5 year rate of recurrent ischemic stroke
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barathi Sethuraman, PhD study director
Abbott
88 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AMPLATZER™ PFO Occluder in people with Stroke and Patent Foramen Ovale, run by Abbott Medical Devices at 88 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 88 sites in United States, Canada, Germany, Italy, Portugal and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Effectiveness: 5 year rate of recurrent ischemic stroke (time frame: Through 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.