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Participants enrolled in this study will have been diagnosed with patent foramen ovale (PFO) and have been scheduled to have a cardiovascular implantable electronic device (CIED) such as a pacemaker, implantable cardioverter-defibrillator (ICD), or cardiac resynchronization therapy (CRT) device implanted. A PFO is a condition when there is a hole in the septum (the wall separating the right and left sides) of the heart.
The purpose of this study is to determine whether closing the PFO with the GORE® Cardioform Septal Occluder in people with an endocardial device leads reduces the risk of recurrent stroke or imaging-confirmed transient ischemic attack (TIA) compared to not closing the PFO.
Foramen Ovale, Patent
Aspirin, Cardiovascular Implantable Device (CIED), Gore Cardioform Septal Occluder
Mayo Clinic in Rochester
Not yet recruiting
Published on BioPortfolio: 2017-07-31T12:53:58-0400
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...
Multi-center, prospective, randomized, placebo- and sham-controlled study to evaluate the GORE® CARDIOFORM Septal Occluder for migraine headache relief
Cardiovascular Implantable Electronic device (CIED) is a evolution therapy and number of patients with it are growing rapidly. Electromagnetic interference causing device malfunction is no...
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 an...
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).
Cardiovascular implantable electronic device (CIED) replacement is increasingly common. It has been proposed that capsule removal at the time of CIED replacement may reduce infection rates. In this st...
Cardiac implantable electronic device (CIED) infections are associated with a high mortality. Our aim was to identify key predictors of survival in patients with CIED infections as to be able to detec...
Cardiac implantable electronic device (CIED) infection, a major complication of a CIED implant procedure, can prolong hospitalization and cause mortality.
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...
The interference of a transtricuspid cardiac implantable electronic device (CIED) lead with tricuspid valve function may contribute to the mechanism of tricuspid regurgitation (TR) and poses specific ...
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.
A non-steroidal anti-inflammatory agent that is less effective than equal doses of ASPIRIN in relieving pain and reducing fever. However, individuals who are hypersensitive to ASPIRIN may tolerate sodium salicylate. In general, this salicylate produces the same adverse reactions as ASPIRIN, but there is less occult gastrointestinal bleeding. (From AMA Drug Evaluations Annual, 1992, p120)
Asthmatic adverse reaction (e.g., BRONCHOCONSTRICTION) to conventional NSAIDS including aspirin use.
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)).
A drug combination of aspirin and dipyridamole that functions as a PLATELET AGGREGATION INHIBITOR, used to prevent THROMBOSIS and STROKE in TRANSIENT ISCHEMIC ATTACK patients.
Cardiology is a specialty of internal medicine. Cardiac electrophysiology : Study of the electrical properties and conduction diseases of the heart. Echocardiography : The use of ultrasound to study the mechanical function/physics of the h...
Cardiovascular disease (CVD)
Acute Coronary Syndromes (ACS) Blood Cardiovascular Dialysis Hypertension Stent Stroke Vascular Cardiovascular disease (CVD) includes all the diseases of the heart and circulation including coronary heart disease (angina...