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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 : February 24, 2023
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Study Description
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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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1214 participants
Allocation: N/A
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 31, 2018
Estimated Primary Completion Date : October 31, 2024
Estimated Study Completion Date : April 30, 2030
Arms and Interventions
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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


Outcome Measures
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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


Eligibility Criteria
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Information from the National Library of Medicine

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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)
Contacts and Locations
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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 maren.wagner@abbott.com

Locations
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Sponsors and Collaborators
Abbott Medical Devices
Investigators
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Study Director: Barathi Sethuraman, PhD Abbott
More Information
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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT03309332    
Other Study ID Numbers: SJM-CIP-10187
First Posted: October 13, 2017    Key Record Dates
Last Update Posted: February 24, 2023
Last Verified: February 2023

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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
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