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GORE® HELEX® Septal Occluder / GORE® Septal Occluder for Patent Foramen Ovale (PFO) Closure in Stroke Patients - The Gore REDUCE Clinical Study

2015-02-18 21:57:43 | BioPortfolio

Summary

The primary objective is to determine if patent foramen ovale (PFO) closure with the GORE® HELEX® Septal Occluder / GORE® Septal Occluder plus antiplatelet medical management is safe and effective and reduces the risk of recurrent stroke or imaging-confirmed transient ischemic attack (TIA) when compared to antiplatelet medical management alone in patients with a PFO and history of cryptogenic stroke or imaging-confirmed TIA.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Stroke

Intervention

GORE® HELEX® Septal Occluder / GORE® Septal Occluder, Antiplatelet Medical Therapy

Location

University of Pennsylvania Medical Center
Philadelphia
Pennsylvania
United States
19104

Status

Active, not recruiting

Source

W.L.Gore & Associates

Results (where available)

View Results

Links

Published on BioPortfolio: 2015-02-18T21:57:43-0500

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Long-term Safety Study of the GORE HELEX(tm) Septal Occluder

The purpose of this study is to evaluate the long-term safety and efficacy of the GORE HELEX(tm) Septal Occluder in the treatment of ostium secundum atrial septal defects (ASDs).

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

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 transfer...

Nickel Allergy With Septal Closure Devices

This study is for patients who have been diagnosed with either a Patent Foramen Ovale [PFO] or an Atrial Septal Defect [ASD]. These are a type of hole located in the wall that separates t...

Endoscopic Closure of Tracheoesophageal Fistulas With Occluder Device

Endoscopic closure of tracheoesophageal fistulas with a device used for closure of cardiac septal defects.

GORE® CARDIOFORM Septal Occluder Migraine Clinical Study: A Study to Evaluate the Safety and Efficacy of Transcatheter Closure of Patent Foramen Ovale for Relief of Migraine Headaches

Multi-center, prospective, randomized, placebo- and sham-controlled study to evaluate the GORE® CARDIOFORM Septal Occluder for migraine headache relief

PubMed Articles [372 Associated PubMed Articles listed on BioPortfolio]

Two cases of pericardial tamponade due to nitinol wire fracture of a gore septal occluder.

Percutaneous patent foramen ovale (PFO) closure is recommended for secondary prevention of paradoxical embolism through a PFO. In the United States, two Food and Drug Administration-approved PFO closu...

Percutaneous closure of restrictive-type perimembranous ventricular septal defect using the new KONAR multifunctional occluder: Midterm outcomes of the first middle-eastern experience.

To evaluate the safety, efficiency, and midterm outcomes of transcatheter perimembranous ventricular septal defect (pmVSD) closure using the new KONAR-MF™ VSD occluder.

Juvenile Central Retinal Artery Occlusion Associated With Atrial Septal Defect.

A 16-year-old boy presented with acute unilateral painless vision loss associated with a central retinal artery occlusion. Subsequent studies revealed an atrial septal defect of 17 mm, which was close...

Cinematic Rendering of an Atrial Septal Occluder Device.

First-in-Human Experience With a Novel Fully Bioabsorbable Occluder for Ventricular Septal Defect.

Medical and Biotech [MESH] Definitions

A CATHETER-delivered implant used for closing abnormal holes in the cardiovascular system, especially HEART SEPTAL DEFECTS; or passageways intentionally made during cardiovascular surgical procedures.

Gray matter structures of the telencephalon and limbic system in the brain, but containing widely varying definitions among authors. Included here is the cortical septal area, subcortical SEPTAL NUCLEI, and the SEPTUM PELLUCIDUM. Many authorities consider the septal region to be made up of the septal area and the septal nuclei, but excluding the septum pellucidum. (Anthoney, Neuroanatomy and the Neurologic Exam, 1994, pp485-489; NeuroNames, http://rprcsgi.rprc.washington.edu/neuronames/index.html (November 18, 1998)).

Incomplete transposition of the great vessels in which both the AORTA and the PULMONARY ARTERY arise from the RIGHT VENTRICLE. The only outlet of the LEFT VENTRICLE is a large ventricular septal defect (VENTRICULAR SEPTAL DEFECTS or VSD). The various subtypes are classified by the location of the septal defect, such as subaortic, subpulmonary, or noncommitted.

Neural nuclei situated in the septal region. They have afferent and cholinergic efferent connections with a variety of forebrain and brainstem areas including the hippocampus, the lateral hypothalamus, the tegmentum, and the amygdala. Included are the dorsal, lateral, medial, and triangular septal nuclei, septofimbrial nucleus, nucleus of diagonal band, nucleus of anterior commissure, and the nucleus of stria terminalis.

Developmental abnormalities in any portion of the VENTRICULAR SEPTUM resulting in abnormal communications between the two lower chambers of the heart. Classification of ventricular septal defects is based on location of the communication, such as perimembranous, inlet, outlet (infundibular), central muscular, marginal muscular, or apical muscular defect.

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Stroke - Cerebrovascular Disease (CVA)
A stroke is a serious medical condition that occurs when the blood supply to part of the brain is cut off. Strokes are a medical emergency and prompt treatment is essential because the sooner a person receives treatment for a stroke, the less damage is ...


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