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PFO PAS: AMPLATZER PFO Occluder Post Approval Study

Sponsor
Abbott Medical Devices (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03309332
Collaborator
(none)
1,214
Enrollment
90
Locations
1
Arm
146.9
Anticipated Duration (Months)
13.5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: AMPLATZER™ PFO Occluder
 N/A

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

Study Type:
Interventional
Anticipated 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 :
Jan 31, 2018
Anticipated Primary Completion Date :
Oct 31, 2024
Anticipated Study Completion Date :
Apr 30, 2030

Arms and Interventions

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

Primary Outcome Measures

  1. Primary Effectiveness: 5 year rate of recurrent ischemic stroke [Through 5 years]

    5 year rate of recurrent ischemic stroke

  2. Primary Safety: Device or procedure related serious adverse events [Through 30 days post implant]

    Device or procedure related serious adverse events through 30 days

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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;

  1. 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

Locations

Site City State Country Postal Code
1 University of Alabama at Birmingham Birmingham Alabama United States 35249
2 Heart Center Research, LLC Huntsville Alabama United States 35801
3 Chandler Regional Medical Center Chandler Arizona United States 85224
4 St. Joseph's Hospital and Medical Center Phoenix Arizona United States 85013
5 Scottsdale Healthcare Shea Scottsdale Arizona United States 85260
6 Pima Heart Physicians, PC Tucson Arizona United States 85712
7 UAMS Medical Center Little Rock Arkansas United States 72205
8 Kaiser Permanente Los Angeles Medical Center Los Angeles California United States 90027
9 USC University Hospital Los Angeles California United States 90033
10 Ronald Reagan UCLA Medical Center Los Angeles California United States 90095
11 Sutter Medical Center Sacramento California United States 95816
12 San Diego Cardiac Center San Diego California United States 92123
13 University of California at San Francisco San Francisco California United States 94143
14 Stanford University Medical Center Stanford California United States 94305
15 Los Robles Hospital and Medical Center Thousand Oaks California United States 91360
16 University of Colorado Hospital Aurora Colorado United States 80045
17 Memorial Hospital of Colorado Springs Colorado Springs Colorado United States 80909
18 Denver Heart Denver Colorado United States 80031
19 South Denver Cardiology Associates PC Littleton Colorado United States 80120
20 Washington Hospital Center Washington District of Columbia United States 20010
21 St. Vincent's Medical Center Jacksonville Florida United States 32204
22 Baptist Medical Center Jacksonville Florida United States 32207
23 First Coast Cardiovascular Institute Jacksonville Florida United States 32256
24 Baptist Hospital of Miami Miami Florida United States 33176
25 Orlando Health Orlando Florida United States 32806
26 Cleveland Clinic Florida Weston Florida United States 33331
27 Emory University Hospital Atlanta Georgia United States 30322
28 Augusta University Augusta Georgia United States 30912
29 Northeast Georgia Medical Center Gainesville Georgia United States 30501
30 WellStar Kennestone Hospital Marietta Georgia United States 98502
31 Rush University Medical Center Chicago Illinois United States 60612
32 Prairie Education and Research Cooperative Springfield Illinois United States 63146
33 St. Vincent Hospital Indianapolis Indiana United States 46240
34 HCA Midwest Division, Menorah Medical Center Overland Park Kansas United States 66209
35 Cardiovascular Research Institute of Kansas Wichita Kansas United States 67214
36 University of Kentucky Lexington Kentucky United States 40536
37 Baptist Hospital East Louisville Kentucky United States 40515
38 Ochsner Medical Center New Orleans Louisiana United States 70448
39 Johns Hopkins University Hospital Baltimore Maryland United States 21287
40 Tufts Medical Center Boston Massachusetts United States 02111
41 Charlton Memorial Hospital Fall River Massachusetts United States 02720
42 McLaren Health Care Corporation Auburn Hills Michigan United States 48326
43 Henry Ford Hospital Detroit Michigan United States 48084
44 Children's Hospital of Michigan Detroit Michigan United States 48201
45 Sparrow Clinical Research Institute Lansing Michigan United States 48912
46 St. Mary's Hospital Duluth Minnesota United States 55805
47 Minneapolis Heart Institute Minneapolis Minnesota United States 55407
48 St. Cloud Hospital Saint Cloud Minnesota United States 56303
49 Washington University School of Medicine Saint Louis Missouri United States 63110
50 Mercy Hospital South Saint Louis Missouri United States 63128
51 St. Patrick Hospital Missoula Montana United States 59802
52 University of Nebraska Medical Center Omaha Nebraska United States 68198
53 Newark Beth Israel Medical Center Newark New Jersey United States 07112
54 Mount Sinai Hospital New York New York United States 10019
55 New York Presbyterian Hospital/ Cornell University New York New York United States 10021
56 Stony Brook University Medical Center Stony Brook New York United States 11790
57 Novant Health Heart and Vascular Research Charlotte North Carolina United States 28204
58 Moses H Cone Memorial Hospital Greensboro North Carolina United States 27358
59 Forsyth Medical Center Winston-Salem North Carolina United States 27358
60 Jewish Hospital Cincinnati Ohio United States 45236
61 TriHealth Bethesda North Hospital Cincinnati Ohio United States 45242
62 Ohio Health Research Institute Columbus Ohio United States 43210
63 Ohio State University Columbus Ohio United States 43210
64 Mt Carmel East Columbus Ohio United States 43213
65 Kaiser Sunnyside Medical Center Clackamas Oregon United States 97015
66 Providence Heart and Vascular Institute Portland Oregon United States 97225
67 Legacy Emanuel Hospital and Health Center Portland Oregon United States 97227
68 Geisinger Medical Center Danville Pennsylvania United States 17822
69 Penn State Milton S Hershey Medical Center Hershey Pennsylvania United States 17033
70 Allegheny Singer Research Institute Pittsburgh Pennsylvania United States 15212
71 Lexington Medical Center West Columbia South Carolina United States 29169
72 Sanford USD Medical Center Sioux Falls South Dakota United States 57117
73 Erlanger Medical Center Chattanooga Tennessee United States 37922
74 Tennova Healthcare - Turkey Creek Medical Center Knoxville Tennessee United States 37920
75 Seton Medical Center Austin Texas United States 78705
76 Park Plaza Hospital Houston Texas United States 77004
77 University of Texas Health Science Center at Houston Houston Texas United States 77074
78 The Heart Hospital Baylor Plano Plano Texas United States 75093
79 Sentara Norfolk General Hospital Norfolk Virginia United States 23112
80 Bayview Physicians Services, PC Virginia Beach Virginia United States 23454
81 Swedish Medical Center - Heart & Vascular Seattle Washington United States 98122
82 University of Washington Medical Center Seattle Washington United States 98195
83 University of Wisconsin Hospital Madison Wisconsin United States 53792
84 Marshfield Clinic Marshfield Wisconsin United States 54449
85 Aurora Medical Group Milwaukee Wisconsin United States 53215
86 Medical College of Wisconsin Milwaukee Wisconsin United States 53226
87 Foothills Medical Centre Calgary Alberta Canada T2N 2T9
88 Vancouver General Hospital Vancouver British Columbia Canada V5Z 1M9
89 Toronto General Hospital Toronto Ontario Canada M5G 2C4
90 Institut de Cardiologie de Montreal (Montreal Heart Inst.) Montréal Quebec Canada H1T 1C8

Sponsors and Collaborators

  • Abbott Medical Devices

Investigators

  • Study Director: Barathi Sethuraman, PhD, Abbott

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Abbott Medical Devices
ClinicalTrials.gov Identifier:
NCT03309332
Other Study ID Numbers:
  • SJM-CIP-10187
First Posted:
Oct 13, 2017
Last Update Posted:
Aug 11, 2022
Last Verified:
Aug 1, 2022
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:
Foramen Ovale, Patent

Study Results

No Results Posted as of Aug 11, 2022