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

Overview

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.

Interventions

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

Primary outcome measures

• Proportion of subjects with recurrent ischemic stroke post study device implant (Primary Effectiveness Outcome) [Time frame: 24 months]
• Proportion of subjects with device- or procedure-related serious adverse events at 30 days (Primary Safety Endpoint) [Time frame: 30 days]

Secondary outcome measures (6)

• Effective PFO Closure defined as complete PFO closure or a trivial or small residual shunt by Echocardiographic assessment [Time frame: 12 months]
• Clinically Significant New Atrial Arrhythmia [Time frame: 60 months]
• Clinically Significant New Atrial Arrhythmia by Age [Time frame: 60 months]
• Residual Shunt Characterization via assessment of shunt in patients by Echo [Time frame: 24 months]
• Technical Success defined as successful delivery and retention of the GSO device based on physician reporting [Time frame: Index procedure]
• Procedural Success defined as successful implantation of the GSO device with no reported in-hospital Serious Adverse Events (SAEs) [Time frame: Enrollment through discharge, approximately 1 day]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Prevention

Study locations

United States · 45 centers

• St. Mary's Hospital — Tucson
• Scripps Health La Jolla — La Jolla
• Loma Linda University Health — Loma Linda
• University of California - San Francisco — San Francisco
• Santa Barbara Cottage Hospital — Santa Barbara
• South Denver Cardiology Associates — Littleton
• Medical Center of the Rockies — Loveland
• Yale University School of Medicine — New Haven
• … and 37 more centers

Identifiers

NCT: NCT03821129 · GSO 18-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗