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
Purpose
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.
Conditions
- Stroke
- PFO - Patent Foramen Ovale
Eligibility
- Eligible Ages
- Between 18 Years and 70 Years
- Eligible Sex
- 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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Prevention
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Other GORE® CARDIOFORM Septal Occluder |
Single Arm Commercially available GORE® CARDIOFORM Septal Occluder |
|
Recruiting Locations
Scripps Health La Jolla
La Jolla, California 92037
La Jolla, California 92037
Loma Linda University Health
Loma Linda, California 92354
Loma Linda, California 92354
University of California - San Francisco
San Francisco, California 94143
San Francisco, California 94143
Contact:
Kaye Reambonanza
415-514-6147
Kaye Reambonanza
415-514-6147
Santa Barbara Cottage Hospital
Santa Barbara, California 93105
Santa Barbara, California 93105
South Denver Cardiology Associates
Littleton, Colorado 80120
Littleton, Colorado 80120
Medical Center of the Rockies
Loveland, Colorado 80538
Loveland, Colorado 80538
Yale University School of Medicine
New Haven, Connecticut 06510
New Haven, Connecticut 06510
Baptist Health Jacksonville
Jacksonville, Florida 32207
Jacksonville, Florida 32207
Contact:
Siddharth Wayanganker, MD
Siddharth Wayanganker, MD
Naples Community Hospital
Naples, Florida 34102
Naples, Florida 34102
Rush University Medical Center
Chicago, Illinois 60612
Chicago, Illinois 60612
Northwestern University
Evanston, Illinois 60208
Evanston, Illinois 60208
University of Iowa Hospitals & Clinic
Iowa City, Iowa 52242
Iowa City, Iowa 52242
Catholic Health Initiatives- Iowa Corp dba Iowa Heart
West Des Moines, Iowa 50266
West Des Moines, Iowa 50266
Massachusetts General Hospital
Boston, Massachusetts 02114
Boston, Massachusetts 02114
University of Michigan
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
Minneapolis Heart Institute Foundation - Abbott Northwestern Hospital
Minneapolis, Minnesota 55407
Minneapolis, Minnesota 55407
Jersey Shore University / Hackensack UMC
Freehold, New Jersey 07728
Freehold, New Jersey 07728
Contact:
Matthew Saybolt, MD
Matthew Saybolt, MD
Research Foundation SUNY Buffalo
Buffalo, New York 14203
Buffalo, New York 14203
Atrium Health
Charlotte, North Carolina 28203
Charlotte, North Carolina 28203
Providence Heart & Vascular Institute
Portland, Oregon 97225
Portland, Oregon 97225
Lehigh Valley Hospital
Allentown, Pennsylvania 18103
Allentown, Pennsylvania 18103
Baylor College of Medicine-Houston
Houston, Texas 77030
Houston, Texas 77030
The Methodist Hospital - Houston
Houston, Texas 77030
Houston, Texas 77030
Baylor Scott & White Memorial Hospital
Temple, Texas 76508
Temple, Texas 76508
St. Marks Hospital
Salt Lake City, Utah 84124
Salt Lake City, Utah 84124
University of Utah
Salt Lake City, Utah 84132
Salt Lake City, Utah 84132
University of Virginia
Charlottesville, Virginia 22908
Charlottesville, Virginia 22908
Multicare Health Tacoma-Multicare Institute for Research & Innovation
Tacoma, Washington 98405
Tacoma, Washington 98405
Charleston Area Medical Center (CAMC)
Charleston, West Virginia 25302
Charleston, West Virginia 25302
Contact:
Richard Han, MD
Richard Han, MD
Aurora Health Care, Metro Inc.
Milwaukee, Wisconsin 53215
Milwaukee, Wisconsin 53215
Medical College of Wisconsin, Inc.
Milwaukee, Wisconsin 53226
Milwaukee, Wisconsin 53226
Contact:
Michael Cinquegrani
Michael Cinquegrani
More Details
- NCT ID
- NCT03821129
- Status
- Recruiting
- Sponsor
- W.L.Gore & Associates
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.