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AMPLATZER PFO Occluder Post Approval Study (PFO PAS)

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ClinicalTrials.gov Identifier: NCT03309332
Recruitment Status : Recruiting
First Posted : October 13, 2017
Last Update Posted : October 4, 2019
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Tracking Information
First Submitted Date  ICMJE October 10, 2017
First Posted Date  ICMJE October 13, 2017
Last Update Posted Date October 4, 2019
Actual Study Start Date  ICMJE January 4, 2018
Estimated Primary Completion Date December 2027   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 12, 2017)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03309332 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE AMPLATZER PFO Occluder Post Approval Study
Official Title  ICMJE OSB Lead-AMPLATZER PFO Occluder New Enrollment PAS
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Stroke
  • Patent Foramen Ovale
Intervention  ICMJE Device: AMPLATZER™ PFO Occluder
Implantation of the AMPLATZER™ PFO Occluder in the PFO
Study Arms  ICMJE Experimental: Device
Subjects implanted with the AMPLATZER™ PFO Occluder.
Intervention: Device: AMPLATZER™ PFO Occluder
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 12, 2017)
1214
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2027
Estimated Primary Completion Date December 2027   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Maren Wagner 651 756 5585 mwagner2@sjm.com
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03309332
Other Study ID Numbers  ICMJE SJM-CIP-10187
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Abbott Medical Devices
Study Sponsor  ICMJE Abbott Medical Devices
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Barathi Sethuraman, PhD Abbott
PRS Account Abbott Medical Devices
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP