AMPLATZER PFO Occluder Post Approval Study

  • STATUS
    Recruiting
  • End date
    Dec 18, 2027
  • participants needed
    1214
  • sponsor
    Abbott Medical Devices
Updated on 18 November 2021
stroke
ischemic stroke

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.

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.

Details
Condition Patent foramen ovale, Cerebrovascular accident, Stroke, ostium secundum atrial septal defect, cerebrovascular accidents, strokes, cerebral
Treatment AMPLATZER™ PFO Occluder
Clinical Study IdentifierNCT03309332
SponsorAbbott Medical Devices
Last Modified on18 November 2021

Eligibility

Yes No Not Sure

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)
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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