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Active, not recruitingNCT03309332PFO PASUpdated Mar 11, 2026

AMPLATZER PFO Occluder Post Approval Study

An interventional study of AMPLATZER™ PFO Occluder in Stroke and Patent Foramen Ovale, sponsored by Abbott Medical Devices. Active, not recruiting at 88 sites in 7 countries. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-03-11.

Sponsored by Abbott Medical Devices (part of Abbott) · Not applicable, Interventional, and Prevention

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Phase
Not applicable
Study type
Interventional
Enrollment
1,214
Allocation
Not applicable
Ages
18 Years to 60 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 19 studies in Stroke by Abbott — none open to participants now, 3 under way, none of them phase 3. Stroke · Abbott.

Enrollment
5th of 10
1,214 · median 1,209
Started
2018
the only one that year
No phase
7 of 19
none open now
Registered
17th of 19
by date

Among the 19 studies in Stroke by Abbott, this one is the 5th largest by enrollment of the 10 interventional ones that give a count, is the only one that started in 2018, is one of 7 with no phase, and was the 17th registered.

Stroke

8,258 studies on the registry are indexed under Stroke; 2,062 are open to participants now.

Browse Stroke studies →

Open to participants now

None of the 19 studies in Stroke by Abbott is open now. The open studies under Stroke, anywhere →

Who these studies take

Of the 1,418 Stroke studies recruiting now, 696 (49%) set no upper age limit and 282 (20%) stop at 75 or younger; 77 take children under 18; 196 take healthy volunteers.

This study: 18 Years to 60 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Download CSVNarrow it in search →With an account: the 19 studies in Stroke by Abbott as a file.
02

Study 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 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.

03

Conditions studied

  • Stroke
  • Patent Foramen Ovale
04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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 (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 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
  • or other illness where is less than 2 years
  • Subjects who will not be available for follow-up for the duration of the trial
  • Inability to obtain from patient
  • Index stroke of poor outcome (modified Rankin score greater than 3)
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
1,214 participants (actual)

Study arms

  • Experimental
    Device

    Subjects implanted with the AMPLATZER™ PFO Occluder.

    Device: AMPLATZER™ PFO Occluder

Interventions

  • DeviceAMPLATZER™ PFO Occluder

    Implantation of the AMPLATZER™ PFO Occluder in the PFO

06

What researchers measure

Primary outcomes

  1. Primary Effectiveness: 5 year rate of recurrent ischemic stroke

    5 year rate of recurrent ischemic stroke

    Time frame: Through 5 years

  2. Primary Safety: Device or procedure related serious adverse events

    Device or procedure related serious adverse events through 30 days

    Time frame: Through 30 days post implant

07

Study locations

88 sites
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2018 (actual). Primary completion is estimated for Feb 2030, 144 months after the start.

Of 144 industry-sponsored interventional studies with no phase under Stroke, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 43. This study's planned 144 months is above that.

Counting every sponsor, half of 3,261 studies reached it within 23 months; a quarter within 10 and three quarters within 46.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 10, 2017
First posted
Oct 13, 2017
StartActual
Jan 31, 2018
Primary completionEst.
Feb 5, 2030
CompletionEst.
Feb 5, 2030
Last update
Mar 11, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03309332
Lead sponsor
Abbott Medical Devices
Responsible party
Sponsor
First posted
Oct 13, 2017
Start date
Jan 31, 2018
Primary completion
Feb 5, 2030 (estimated)
Completion
Feb 5, 2030 (estimated)
Last update
Mar 11, 2026

Study contacts

Barathi Sethuraman, PhD
study director · Abbott

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

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