Clinical trial NCT03821129: 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
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
PFO - Patent Foramen Ovale
Keywords: Occluder
Patent Foramen Ovale
PFO
Stroke
Gore Septal Occluder
Lead sponsor: W.L.Gore & Associates
Sponsor class: INDUSTRY
First posted: 2019-01-29
Enrollment: 636
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of subjects with recurrent ischemic stroke post study device implant (Primary Effectiveness Outcome)
timeFrame: 24 months
measure: Proportion of subjects with device- or procedure-related serious adverse events at 30 days (Primary Safety Endpoint)
timeFrame: 30 days
Secondary outcomes:
measure: Effective PFO Closure defined as complete PFO closure or a trivial or small residual shunt by Echocardiographic assessment
timeFrame: 12 months
measure: Clinically Significant New Atrial Arrhythmia
timeFrame: 60 months
measure: Clinically Significant New Atrial Arrhythmia by Age
timeFrame: 60 months
measure: Residual Shunt Characterization via assessment of shunt in patients by Echo
timeFrame: 24 months
measure: Technical Success defined as successful delivery and retention of the GSO device based on physician reporting
timeFrame: Index procedure
measure: Procedural Success defined as successful implantation of the GSO device with no reported in-hospital Serious Adverse Events (SAEs)
timeFrame: Enrollment through discharge, approximately 1 day
Other outcomes:
Locations:
city: Tucson
country: United States
facility: St. Mary's Hospital
state: Arizona
city: La Jolla
country: United States
facility: Scripps Health La Jolla
state: California
city: Loma Linda
country: United States
facility: Loma Linda University Health
state: California
city: San Francisco
country: United States
facility: University of California - San Francisco
state: California
city: Santa Barbara
country: United States
facility: Santa Barbara Cottage Hospital
state: California
city: Littleton
country: United States
facility: South Denver Cardiology Associates
state: Colorado
city: Loveland
country: United States
facility: Medical Center of the Rockies
state: Colorado
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Naples
country: United States
facility: Naples Community Hospital
state: Florida
city: Weston
country: United States
facility: Cleveland Clinic Florida
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Elk Grove Village
country: United States
facility: Alexian Brothers Medical Center
state: Illinois
city: Evanston
country: United States
facility: Northwestern University
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa Hospitals & Clinic
state: Iowa
city: West Des Moines
country: United States
facility: Catholic Health Initiatives- Iowa Corp dba Iowa Heart
state: Iowa
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Saginaw
country: United States
facility: Covenant Medical Center, Inc.
state: Michigan
city: Edina
country: United States
facility: University of Minnesota
state: Minnesota
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute Foundation - Abbott Northwestern Hospital
state: Minnesota
city: Buffalo
country: United States
facility: Research Foundation SUNY Buffalo
state: New York
city: New York
country: United States
facility: Columbia University Medical Center/NYPH
state: New York
city: Charlotte
country: United States
facility: Atrium Health
state: North Carolina
city: Portland
country: United States
facility: Providence Heart & Vascular Institute
state: Oregon
city: Allentown
country: United States
facility: Lehigh Valley Hospital
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Knoxville
country: United States
facility: Tennova Healthcare
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Houston
country: United States
facility: Baylor College of Medicine-Houston
state: Texas
city: Houston
country: United States
facility: The Methodist Hospital - Houston
state: Texas
city: San Antonio
country: United States
facility: Methodist Healthcare Systems of San Antonio d/b/a Methodist Hospital
state: Texas
city: Temple
country: United States
facility: Baylor Scott & White Memorial Hospital
state: Texas
city: Salt Lake City
country: United States
facility: St. Marks Hospital
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Norfolk
country: United States
facility: Sentara Cardiovascular Research Institute
state: Virginia
city: Tacoma
country: United States
facility: Multicare Health Tacoma-Multicare Institute for Research & Innovation
state: Washington
city: Milwaukee
country: United States
facility: Aurora Health Care, Metro Inc.
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical College of Wisconsin, Inc.
state: Wisconsin
Study officials:
References: