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 (REDUCE PAS)

W.L. Gore & Associates

Status

Enrolling

Conditions

PFO - Patent Foramen Ovale

Stroke

Treatments

Device: PFO closure with GORE® CARDIOFORM Septal Occluder

Study type

Interventional

Funder types

Industry

Identifiers

NCT03821129

GSO 18-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

636 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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