AMPLATZER PFO Occluder Post Approval Study (PFO PAS)

• ClinicalTrials.gov Identifier: NCT03309332
• Recruitment Status: Recruiting
• First Posted: October 13, 2017
• Last Update Posted: January 13, 2021
• Sponsor: Abbott Medical Devices
• Information provided by (Responsible Party): Abbott Medical Devices

Tracking Information

• First Submitted Date: October 10, 2017
• First Posted Date: October 13, 2017
• Last Update Posted Date: January 13, 2021
• Actual Study Start Date: January 4, 2018
• Estimated Primary Completion Date: December 2027 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: AMPLATZER PFO Occluder Post Approval Study
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Prevention

Condition

• Stroke
• Patent Foramen Ovale

Intervention

Device: AMPLATZER™ PFO Occluder

Implantation of the AMPLATZER™ PFO Occluder in the PFO

Study Arms

Experimental: Device

Subjects implanted with the AMPLATZER™ PFO Occluder.

Intervention: Device: AMPLATZER™ PFO Occluder

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: October 12, 2017): 1214
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2027
• Estimated Primary Completion Date: December 2027 (Final data collection date for primary outcome measure)

Eligibility 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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Maren Wagner; 651 756 5585; mwagner2@sjm.com

• Listed Location Countries: Canada, United States

Administrative Information

• NCT Number: NCT03309332
• Other Study ID Numbers: 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
• Product Manufactured in and Exported from the U.S.: No

• IPD Sharing Statement: Not Provided
• Responsible Party: Abbott Medical Devices
• Study Sponsor: Abbott Medical Devices
• Collaborators: Not Provided

Investigators

• Study Director: Barathi Sethuraman, PhD; Abbott

• PRS Account: Abbott Medical Devices
• Verification Date: January 2021