AMPLATZER PFO Occluder Post Approval Study

Stroke Clinical Trial

— PFO PAS  

Official title:

OSB Lead-AMPLATZER PFO Occluder New Enrollment PAS

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03309332
• Other study ID #: SJM-CIP-10187
• Status: Recruiting
• Phase: N/A
• Start date: January 31, 2018
• Est. completion date: April 30, 2030

Study information

• Verified date: April 2024
• Source: Abbott Medical Devices
• Contact: Maren Wagner
• Phone: 651 756 5585
• Email: maren.wagner[@]abbott.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1214
• Est. completion date: April 30, 2030
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Foramen Ovale, Patent
• Patent Foramen Ovale
• Stroke

Intervention

Device:
• AMPLATZER™ PFO Occluder
Implantation of the AMPLATZER™ PFO Occluder in the PFO

Locations

Country	Name	City	State
Canada	Foothills Medical Centre	Calgary	Alberta
Canada	Institut de Cardiologie de Montreal (Montreal Heart Inst.)	Montréal	Quebec
Canada	Toronto General Hospital	Toronto	Ontario
Canada	Vancouver General Hospital	Vancouver	British Columbia
Germany	Deutsches Herzzentrum Berlin	Berlin
Germany	Deutsches Herzzentrum München des Freistaates Bayern	München	Bavaria
Italy	Centro Cardiologico Monzino	Milano	Lombard
Portugal	Santa Maria Hospital	Lisboa	Lisbon
Switzerland	Kantonsspital St.Gallen	Saint Gallen	Stgalln
United Kingdom	St. Thomas Hospital	London
United States	Emory University Hospital	Atlanta	Georgia
United States	McLaren Health Care Corporation	Auburn Hills	Michigan
United States	Augusta University	Augusta	Georgia
United States	University of Colorado Hospital	Aurora	Colorado
United States	Seton Medical Center	Austin	Texas
United States	Johns Hopkins University Hospital	Baltimore	Maryland
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Tufts Medical Center	Boston	Massachusetts
United States	Chandler Regional Medical Center	Chandler	Arizona
United States	Novant Health Heart and Vascular Research	Charlotte	North Carolina
United States	Erlanger Medical Center	Chattanooga	Tennessee
United States	Rush University Medical Center	Chicago	Illinois
United States	Jewish Hospital	Cincinnati	Ohio
United States	TriHealth Bethesda North Hospital	Cincinnati	Ohio
United States	Kaiser Sunnyside Medical Center	Clackamas	Oregon
United States	Memorial Hospital of Colorado Springs	Colorado Springs	Colorado
United States	Mt Carmel East	Columbus	Ohio
United States	Ohio Health Research Institute	Columbus	Ohio
United States	Ohio State University	Columbus	Ohio
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	Denver Heart	Denver	Colorado
United States	Children's Hospital of Michigan	Detroit	Michigan
United States	Henry Ford Hospital	Detroit	Michigan
United States	St. Mary's Hospital	Duluth	Minnesota
United States	Charlton Memorial Hospital	Fall River	Massachusetts
United States	Northeast Georgia Medical Center	Gainesville	Georgia
United States	Moses H Cone Memorial Hospital	Greensboro	North Carolina
United States	Penn State Milton S Hershey Medical Center	Hershey	Pennsylvania
United States	Park Plaza Hospital	Houston	Texas
United States	University of Texas Health Science Center at Houston	Houston	Texas
United States	Heart Center Research, LLC	Huntsville	Alabama
United States	St. Vincent Hospital	Indianapolis	Indiana
United States	Baptist Medical Center	Jacksonville	Florida
United States	First Coast Cardiovascular Institute	Jacksonville	Florida
United States	St. Vincent's Medical Center	Jacksonville	Florida
United States	Tennova Healthcare - Turkey Creek Medical Center	Knoxville	Tennessee
United States	Sparrow Clinical Research Institute	Lansing	Michigan
United States	University of Kentucky	Lexington	Kentucky
United States	UAMS Medical Center	Little Rock	Arkansas
United States	South Denver Cardiology Associates PC	Littleton	Colorado
United States	Kaiser Permanente Los Angeles Medical Center	Los Angeles	California
United States	Ronald Reagan UCLA Medical Center	Los Angeles	California
United States	USC University Hospital	Los Angeles	California
United States	Baptist Hospital East	Louisville	Kentucky
United States	University of Wisconsin Hospital	Madison	Wisconsin
United States	WellStar Kennestone Hospital	Marietta	Georgia
United States	Marshfield Clinic	Marshfield	Wisconsin
United States	Baptist Hospital of Miami	Miami	Florida
United States	Aurora Medical Group	Milwaukee	Wisconsin
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Minneapolis Heart Institute	Minneapolis	Minnesota
United States	St. Patrick Hospital	Missoula	Montana
United States	Ochsner Medical Center	New Orleans	Louisiana
United States	Mount Sinai Hospital	New York	New York
United States	New York Presbyterian Hospital/ Cornell University	New York	New York
United States	Newark Beth Israel Medical Center	Newark	New Jersey
United States	Sentara Norfolk General Hospital	Norfolk	Virginia
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	Orlando Health	Orlando	Florida
United States	HCA Midwest Division, Menorah Medical Center	Overland Park	Kansas
United States	St. Joseph's Hospital and Medical Center	Phoenix	Arizona
United States	Allegheny Singer Research Institute	Pittsburgh	Pennsylvania
United States	The Heart Hospital Baylor Plano	Plano	Texas
United States	Legacy Emanuel Hospital and Health Center	Portland	Oregon
United States	Providence Heart and Vascular Institute	Portland	Oregon
United States	Sutter Medical Center	Sacramento	California
United States	St. Cloud Hospital	Saint Cloud	Minnesota
United States	Mercy Hospital South	Saint Louis	Missouri
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	San Diego Cardiac Center	San Diego	California
United States	University of California at San Francisco	San Francisco	California
United States	Scottsdale Healthcare Shea	Scottsdale	Arizona
United States	Swedish Medical Center - Heart & Vascular	Seattle	Washington
United States	University of Washington Medical Center	Seattle	Washington
United States	Sanford USD Medical Center	Sioux Falls	South Dakota
United States	Prairie Education and Research Cooperative	Springfield	Illinois
United States	Stanford University Medical Center	Stanford	California
United States	Stony Brook University Medical Center	Stony Brook	New York
United States	Los Robles Hospital and Medical Center	Thousand Oaks	California
United States	Pima Heart Physicians, PC	Tucson	Arizona
United States	Bayview Physicians Services, PC	Virginia Beach	Virginia
United States	Washington Hospital Center	Washington	District of Columbia
United States	Lexington Medical Center	West Columbia	South Carolina
United States	Cleveland Clinic Florida	Weston	Florida
United States	Cardiovascular Research Institute of Kansas	Wichita	Kansas
United States	Forsyth Medical Center	Winston-Salem	North Carolina
United States	University of Massachusetts Medical Center	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

United States,  Canada,  Germany,  Italy,  Portugal,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Effectiveness: 5 year rate of recurrent ischemic stroke	5 year rate of recurrent ischemic stroke	Through 5 years
Primary	Primary Safety: Device or procedure related serious adverse events	Device or procedure related serious adverse events through 30 days	Through 30 days post implant