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REDUCE PAS: GORE® CARDIOFORM Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke in Patients With Patent Foramen Ovale (PFO): the REDUCE Post Approval Study

Sponsor
W.L.Gore & Associates (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03821129
Collaborator
(none)
636
Enrollment
39
Locations
1
Arm
124.3
Anticipated Duration (Months)
16.3
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will assess the safety and effectiveness of GORE® CARDIOFORM Septal Occluder in a post approval setting and evaluate the quality of operator education and training and transferability of trial experience to a post-market setting.

Condition or Disease Intervention/Treatment Phase
  • Device: PFO closure with GORE® CARDIOFORM Septal Occluder
 N/A

Detailed Description

A maximum of 636 adult subjects will be enrolled at up to 40 U.S. centers. 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 :
636 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
GORE® CARDIOFORM Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke in Patients With Patent Foramen Ovale (PFO): the REDUCE Post Approval Study
Actual Study Start Date :
Jul 25, 2019
Anticipated Primary Completion Date :
Dec 1, 2026
Anticipated Study Completion Date :
Dec 1, 2029

Arms and Interventions

Arm Intervention/Treatment
Other: GORE® CARDIOFORM Septal Occluder

Single Arm Commercially available GORE® CARDIOFORM Septal Occluder

Device: PFO closure with GORE® CARDIOFORM Septal Occluder
PFO closure with GORE® CARDIOFORM Septal Occluder in patients with ischemic stroke

Outcome Measures

Primary Outcome Measures

  1. Proportion of subjects with recurrent ischemic stroke post study device implant (Primary Effectiveness Outcome) [24 months]

    Proportion of subjects with recurrent ischemic stroke post study device implant

  2. Proportion of subjects with device- or procedure-related serious adverse events at 30 days (Primary Safety Endpoint) [30 days]

    Device- or procedure- related serious adverse events post study device implant

Secondary Outcome Measures

  1. Effective PFO Closure defined as complete PFO closure or a trivial or small residual shunt by Echocardiographic assessment [12 months]

    Complete PFO closure or a trivial or small residual shunt Proportion of subjects with complete PFO closure or a trivial or small residual shunt

  2. Clinically Significant New Atrial Arrhythmia [60 months]

    Any new atrial fibrillation or flutter

  3. Clinically Significant New Atrial Arrhythmia by Age [60 months]

    Any new atrial fibrillation or flutter in patients greater and less than 60 years of age

  4. Residual Shunt Characterization via assessment of shunt in patients by Echo [24 months]

    Assessment of shunt in patients by Echo

  5. Technical Success defined as successful delivery and retention of the GSO device based on physician reporting [Index procedure]

    Successful delivery and retention of the GSO device

  6. Procedural Success defined as successful implantation of the GSO device with no reported in-hospital Serious Adverse Events (SAEs) [Enrollment through discharge, approximately 1 day]

    Successful implantation of the GSO device with no reported in-hospital SAEs

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Diagnosed with an ischemic stroke presumed to be an embolic stroke of undetermined source (ESUS) verified by a neurologist within the last 365 days prior to enrollment.

  • Presence of Patent Foramen Ovale (PFO), as determined initially by positive bubble study utilizing transesophageal echocardiography (TEE) and/or transcranial Doppler (TCD), demonstrating spontaneous right-to-left shunting or right-to-left shunting during Valsalva maneuver.

  • Patient is able to tolerate antiplatelet therapy

  • Note: Additional Inclusion Criteria may apply

Exclusion Criteria:

  • History of or ongoing atrial fibrillation/flutter

  • Other co-morbidities including, but not limited to, mural thrombus, dilated cardiomyopathy, cardiac prosthetics (valves), severe native valve disease (including mitral valve stenosis), severe ventricular wall motion abnormalities, aortic dissection, significant atherosclerosis, vasculitis, pre-existing non-vascular neurologic disorders, pulmonary arteriovenous malformations, prior intracranial hemorrhage, severe disability related to prior stroke, autoimmune disorders that would increase the risk of stroke or thromboembolism, or associated with increased risk of infection or procedural complications, in the opinion of the investigator, left ventricular ejection fraction of <40%, coexistent cause or intra-cardiac shunting (e.g. VSD or ASD)

  • Previous Myocardial Infarction

  • Rankin Scale sore greater than or equal to 3 at the time of procedure

  • Active infection that cannot be treated successfully prior to enrollment

  • Neurological deficits not due to stroke that may affect the patient's neurologic assessments

  • Evidence of hypercoagulable state, Uncontrolled diabetes mellitus, uncontrolled systemic hypertension or pulmonary hypertension at the time of screening or procedure

  • Sensitivity or contraindication to all proposed medical treatments or any device components

  • Pregnant, lactating, or intent on becoming pregnant through 24 months after enrollment.

  • Indications outside the parameters accepted for placement of GSO, including extensive congenital cardiac anomalies and defect diameters considered too large for closure with the device.

  • Atrial septal anatomy that is expected to necessitate placement of more than one GORE® CARDIOFORM Septal Occluder

  • Need for concomitant procedure(s) that may confound detection of adverse events related to device placement

  • Note: Additional Exclusion Criteria may apply

Contacts and Locations

Locations

Site City State Country Postal Code
1 Scripps Health La Jolla La Jolla California United States 92037
2 Loma Linda University Health Loma Linda California United States 92354
3 University of California - San Francisco San Francisco California United States 94143
4 Santa Barbara Cottage Hospital Santa Barbara California United States 93105
5 South Denver Cardiology Associates Littleton Colorado United States 80120
6 Medical Center of the Rockies Loveland Colorado United States 80538
7 Yale University School of Medicine New Haven Connecticut United States 06510
8 Naples Community Hospital Naples Florida United States 34102
9 Cleveland Clinic Florida Weston Florida United States 33331
10 Emory University Atlanta Georgia United States 30322
11 Rush University Medical Center Chicago Illinois United States 60612
12 Alexian Brothers Medical Center Elk Grove Village Illinois United States 60007
13 Northwestern University Evanston Illinois United States 60208
14 University of Iowa Hospitals & Clinic Iowa City Iowa United States 52242
15 Catholic Health Initiatives- Iowa Corp dba Iowa Heart West Des Moines Iowa United States 50266
16 Massachusetts General Hospital Boston Massachusetts United States 02114
17 University of Michigan Ann Arbor Michigan United States 48109
18 William Beaumont Hospital Royal Oak Michigan United States 48073
19 Covenant Medical Center, Inc. Saginaw Michigan United States 48602
20 Fairview Health Services (Univ of MN) Edina Minnesota United States 55109
21 University of Minnesota Edina Minnesota United States 55435
22 Minneapolis Heart Institute Foundation - Abbott Northwestern Hospital Minneapolis Minnesota United States 55407
23 Research Foundation SUNY Buffalo Buffalo New York United States 14203
24 Columbia University Medical Center/NYPH New York New York United States 10032
25 Atrium Health Charlotte North Carolina United States 28203
26 Providence Heart & Vascular Institute Portland Oregon United States 97225
27 Lehigh Valley Hospital Allentown Pennsylvania United States 18103
28 Medical University of South Carolina Charleston South Carolina United States 29425
29 Tennova Healthcare Knoxville Tennessee United States 37934
30 Vanderbilt University Medical Center Nashville Tennessee United States 37232
31 Baylor College of Medicine-Houston Houston Texas United States 77030
32 The Methodist Hospital - Houston Houston Texas United States 77030
33 Methodist Healthcare Systems of San Antonio d/b/a Methodist Hospital San Antonio Texas United States 78229
34 University of Utah Salt Lake City Utah United States 84132
35 University of Virginia Charlottesville Virginia United States 22908
36 Sentara Cardiovascular Research Institute Norfolk Virginia United States 23455
37 University of Washington Seattle Washington United States 98195
38 Aurora Health Care, Metro Inc. Milwaukee Wisconsin United States 53215
39 Medical College of Wisconsin, Inc. Milwaukee Wisconsin United States 53226

Sponsors and Collaborators

  • W.L.Gore & Associates

Investigators

  • Principal Investigator: Ignacio Inglessis, MD, Interventional Cardiology Associates
  • Principal Investigator: John Volpi, MD, The Methodist Hospital Research Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
W.L.Gore & Associates
ClinicalTrials.gov Identifier:
NCT03821129
Other Study ID Numbers:
  • GSO 18-01
First Posted:
Jan 29, 2019
Last Update Posted:
Jun 7, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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.:
Yes
Keywords provided by W.L.Gore & Associates
Occluder
Patent Foramen Ovale
PFO
Stroke
Gore Septal Occluder
Additional relevant MeSH terms:
Stroke
Foramen Ovale, Patent

Study Results

No Results Posted as of Jun 7, 2022