Patent Foramen Ovale Closure or Medical Therapy After Str... | NCT00465270

ID	Type	Description	Link
G990318

Label	Type	Description	Intervention Names
Device	Experimental	AMPLATZER PFO Occluder	Device: AMPLATZER PFO Occluder
Standard or Care - Medical Management	Active Comparator	Medical treatment with Aspirin alone, Coumadin alone, Clopidogrel alone, or Aspirin combined with dipyridamole.	Other: Standard of Care - Medical Management

Name	Type	Description	Arm Group Labels	Other Names
AMPLATZER PFO Occluder	Device	patent foramen ovale closure device	Device

Measure	Description	Time Frame
Composite of Recurrent Nonfatal Ischemic Stroke, Fatal Ischemic Stroke, or Early Death After Randomization	Nonfatal stroke is defined as: focal neurological deficit presumed to be due to focal ischemia, and either 1) symptoms persisting 24 hours or greater, or 2) symptoms persisting less than 24 hours but associated with MR or CT imaging findings of a new, neuroanatomically relevent, cergral infarct. Post-randomization death is defined as: in the MM group as all-cause mortality within 45 days after randomization, and in the device group as all-cause mortality 30 days after implant or 45 days after randomizaiton, whichever occurs last.	Trial enrollment was stopped once 25 unique subjects were mutually adjudicated by the CEC and DSMB as having experienced a primary endpoint event. This occurred on December 20, 2011. The mean follow-up time was 2.6 years.

Measure	Description	Time Frame
Rate of Complete PFO Closure (Assessed by TEE Bubble Study) at the 6-month Follow-up in the Device Group		6 months

Name	Affiliation	Role
Jeffrey Saver, MD	UCLA Stroke Center	Principal Investigator
John D Carroll, MD	University of Colorado, Denver	Principal Investigator
Richard Smalling, MD	University of Texas Houston Health Science Center	Principal Investigator
David Thaler, MD	Tufts Medical Center	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama		Birmingham	Alabama	35249	United States
Mayo Clinic

PubMed Identifier	Type	Citation	Retractions
28902590	Background	Saver JL, Carroll JD, Thaler DE, Smalling RW, MacDonald LA, Marks DS, Tirschwell DL; RESPECT Investigators. Long-Term Outcomes of Patent Foramen Ovale Closure or Medical Therapy after Stroke. N Engl J Med. 2017 Sep 14;377(11):1022-1032. doi: 10.1056/NEJMoa1610057.
23514286	Background	Carroll JD, Saver JL, Thaler DE, Smalling RW, Berry S, MacDonald LA, Marks DS, Tirschwell DL; RESPECT Investigators. Closure of patent foramen ovale versus medical therapy after cryptogenic stroke. N Engl J Med. 2013 Mar 21;368(12):1092-100. doi: 10.1056/NEJMoa1301440.

Label	URL
Related Info	View source

ID	Title	Description
FG000	Device	AMPLATZER PFO Occluder: patent foramen ovale closure device
FG001	Medical Management	Aspirin alone, Coumadin alone, Clopidogrel alone, or Aspirin combined with dipyridamole.

Serious Adverse Events

Term	Organ System	Statistical Information
ASD	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Abdominal Pain	General disorders	EG0002 events2 affected499 at risk EG0013 events2 affected481 at risk
Abnormal Lab Value	General disorders	EG0000 events0 affected499 at risk EG0011 events1 affected481 at risk
Acute Bacterial Endocarditis (ABE)	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Acute Bronchitis	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Acute Erosive Gastritis	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Acute Gastroenteritis	General disorders	EG0002 events2 affected499 at risk EG0010 events0 affected481 at risk
Acute Pancreatitis	General disorders	EG0002 events2 affected499 at risk EG0010 events0 affected481 at risk
Acute Peritonitis	General disorders	EG0000 events0 affected499 at risk EG0011 events1 affected481 at risk
Acute Pulmonary Edema	General disorders	EG0000 events0 affected499 at risk EG0011 events1 affected481 at risk
Acute Renal Failure	General disorders	EG0001 events1 affected499 at risk EG0011 events1 affected481 at risk
Acute Subdural Hematoma	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Alcohol Intoxication	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Allergic Device Reaction	General disorders	EG0000 events0 affected499 at risk EG0011 events1 affected481 at risk
Allergic Drug Reaction	General disorders	EG0002 events2 affected499 at risk EG0010 events0 affected481 at risk
Altered Sensorium	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Anemias	General disorders	EG0004 events4 affected499 at risk EG0010 events0 affected481 at risk
Angina Pectoris	General disorders	EG0001 events1 affected499 at risk EG0011 events1 affected481 at risk
Ankle Fracture	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Anterior Meniscus Tear	General disorders	EG0000 events0 affected499 at risk EG0011 events1 affected481 at risk
Anxiety	General disorders	EG0000 events0 affected499 at risk EG0012 events2 affected481 at risk
Aortic Aneurysms	General disorders	EG0002 events2 affected499 at risk EG0010 events0 affected481 at risk
Appendicitis	General disorders	EG0004 events4 affected499 at risk EG0012 events2 affected481 at risk
Arm Fracture	General disorders	EG0002 events2 affected499 at risk EG0011 events1 affected481 at risk
Arterial Hypertension/Hypertension	General disorders	EG0004 events4 affected499 at risk EG0011 events1 affected481 at risk
Arthritis	General disorders	EG0002 events2 affected499 at risk EG0010 events0 affected481 at risk
Asthma	General disorders	EG0002 events2 affected499 at risk EG0011 events1 affected481 at risk
Atrial Fibrillation	General disorders	EG0008 events6 affected499 at risk EG0014 events4 affected481 at risk
Atrial Flutter	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Back Pain	General disorders	EG0001 events1 affected499 at risk EG0012 events2 affected481 at risk
Bacterial Infections	General disorders	EG0000 events0 affected499 at risk EG0013 events3 affected481 at risk
Bacterial Infections of the Skin	General disorders	EG0003 events2 affected499 at risk EG0011 events1 affected481 at risk
Benign Mass	General disorders	EG0000 events0 affected499 at risk EG0011 events1 affected481 at risk
Bipolar Disorder	General disorders	EG0002 events2 affected499 at risk EG0010 events0 affected481 at risk
Birth Defect	General disorders	EG0000 events0 affected499 at risk EG0011 events1 affected481 at risk
Bleeding	General disorders	EG0003 events3 affected499 at risk EG0011 events1 affected481 at risk
Blood Loss	General disorders	EG0000 events0 affected499 at risk EG0011 events1 affected481 at risk
Bowel Obstruction	General disorders	EG0005 events4 affected499 at risk EG0012 events2 affected481 at risk
Brain Abcess	General disorders	EG0000 events0 affected499 at risk EG0011 events1 affected481 at risk
Brain Tumor	General disorders	EG0000 events0 affected499 at risk EG0012 events2 affected481 at risk
Breast Cancer	General disorders	EG0006 events6 affected499 at risk EG0012 events2 affected481 at risk
Bronchiolitis	General disorders	EG0000 events0 affected499 at risk EG0011 events1 affected481 at risk
Bronchitis	General disorders	EG0000 events0 affected499 at risk EG0011 events1 affected481 at risk
Burns	General disorders	EG0001 events1 affected499 at risk EG0011 events1 affected481 at risk
Caesarean Section	General disorders	EG0005 events5 affected499 at risk EG0014 events3 affected481 at risk
Cancer	General disorders	EG0006 events5 affected499 at risk EG0017 events7 affected481 at risk
Cardiac Arrest	General disorders	EG0001 events1 affected499 at risk EG0013 events3 affected481 at risk
Cardiac Perforation	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Cardiac Thrombus	General disorders	EG0002 events2 affected499 at risk EG0010 events0 affected481 at risk
Cardiomyopathy	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Cellulitis	General disorders	EG0003 events2 affected499 at risk EG0016 events6 affected481 at risk
Cerebral Aneurysm	General disorders	EG0000 events0 affected499 at risk EG0012 events2 affected481 at risk
Cerebral Infarct - Asymptomatic***	General disorders	EG0000 events0 affected499 at risk EG0012 events2 affected481 at risk
Cerebrospinal Fluid (CSF) Leak	General disorders	EG0000 events0 affected499 at risk EG0011 events1 affected481 at risk
Cervical Spondylosis	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Cervical Stenosis	General disorders	EG0002 events2 affected499 at risk EG0011 events1 affected481 at risk
Chest Pain	General disorders	EG00019 events18 affected499 at risk EG00116 events15 affected481 at risk
Chest Tightness	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Chills/Rigors	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Cholecystitis	General disorders	EG0001 events1 affected499 at risk EG0015 events5 affected481 at risk
Choledochal Cysts	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Choledocholithiaisis	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Cholelithiasis	General disorders	EG0003 events3 affected499 at risk EG0010 events0 affected481 at risk
Chronic Obstructive Airway Disorders	General disorders	EG0000 events0 affected499 at risk EG0011 events1 affected481 at risk
Chronic Obstructive Pulmonary Disease (COPD)	General disorders	EG0000 events0 affected499 at risk EG0011 events1 affected481 at risk
Chronic Pancreatitis	General disorders	EG0002 events1 affected499 at risk EG0010 events0 affected481 at risk
Closed Head Injury	General disorders	EG0001 events1 affected499 at risk EG0011 events1 affected481 at risk
Colitis	General disorders	EG0003 events3 affected499 at risk EG0012 events2 affected481 at risk
Colon Cancer	General disorders	EG0003 events1 affected499 at risk EG0011 events1 affected481 at risk
Common Cold/Upper Respiratory Tract Infection	General disorders	EG0000 events0 affected499 at risk EG0011 events1 affected481 at risk
Compartment Syndrome	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Complex Partial Seizures	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Confusion	General disorders	EG0000 events0 affected499 at risk EG0013 events2 affected481 at risk
Congestive Heart Failure	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Conversion Reaction	General disorders	EG0003 events2 affected499 at risk EG0010 events0 affected481 at risk
Coronary Artery Disease	General disorders	EG0003 events3 affected499 at risk EG0012 events2 affected481 at risk
Cutaneous Abcesses	General disorders	EG0002 events2 affected499 at risk EG0011 events1 affected481 at risk
Deep Vein/Venous Thrombosis	General disorders	EG0005 events5 affected499 at risk EG0011 events1 affected481 at risk
Dehydration	General disorders	EG0000 events0 affected499 at risk EG0012 events2 affected481 at risk
Delirium	General disorders	EG0000 events0 affected499 at risk EG0011 events1 affected481 at risk
Depression	General disorders	EG0003 events2 affected499 at risk EG0015 events4 affected481 at risk
Disc Protrusion	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Diverticulitis	General disorders	EG0003 events3 affected499 at risk EG0011 events1 affected481 at risk
Dizziness	General disorders	EG0003 events2 affected499 at risk EG0012 events2 affected481 at risk
Drug Side Effect	General disorders	EG0000 events0 affected499 at risk EG0011 events1 affected481 at risk
Duodenal Cancer	General disorders	EG0000 events0 affected499 at risk EG0011 events1 affected481 at risk
Dysarthria/Slurred Speech	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Dyspnea	General disorders	EG0003 events3 affected499 at risk EG0011 events1 affected481 at risk
Elective Surgery	General disorders	EG00032 events26 affected499 at risk EG00120 events17 affected481 at risk
Emesis/Vomiting	General disorders	EG0000 events0 affected499 at risk EG0011 events1 affected481 at risk
Encephalopathy	General disorders	EG0000 events0 affected499 at risk EG0012 events2 affected481 at risk
Eye Lacerations	General disorders	EG0000 events0 affected499 at risk EG0011 events1 affected481 at risk
Failure to Thrive	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Fall	General disorders	EG0003 events3 affected499 at risk EG0012 events2 affected481 at risk
Fenestrated Atrial Septum	General disorders	EG0002 events2 affected499 at risk EG0010 events0 affected481 at risk
Fever	General disorders	EG0002 events1 affected499 at risk EG0010 events0 affected481 at risk
Fracture	General disorders	EG0004 events3 affected499 at risk EG0010 events0 affected481 at risk
Gastritis	General disorders	EG0000 events0 affected499 at risk EG0011 events1 affected481 at risk
Gastroenteritis	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Gastroesophageal Reflux Disease	General disorders	EG0000 events0 affected499 at risk EG0012 events2 affected481 at risk
Gastrointestinal Bleeding	General disorders	EG0006 events6 affected499 at risk EG0014 events4 affected481 at risk
Generalized Seizures	General disorders	EG0001 events1 affected499 at risk EG0011 events1 affected481 at risk
Generalized Tonic-Clonic Seizures	General disorders	EG0001 events1 affected499 at risk EG0011 events1 affected481 at risk
Headache	General disorders	EG0004 events4 affected499 at risk EG0011 events1 affected481 at risk
Hematoma	General disorders	EG0002 events1 affected499 at risk EG0012 events2 affected481 at risk
Hemiparesis/Weakness	General disorders	EG0002 events2 affected499 at risk EG0010 events0 affected481 at risk
Hemorrhagic Stroke	General disorders	EG0000 events0 affected499 at risk EG0011 events1 affected481 at risk
Hepatic and Biliary Disorders	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Hernia	General disorders	EG0000 events0 affected499 at risk EG0011 events1 affected481 at risk
Herniated Disc	General disorders	EG0002 events2 affected499 at risk EG0010 events0 affected481 at risk
Hip Dislocation	General disorders	EG0000 events0 affected499 at risk EG0012 events1 affected481 at risk
Hip Fracture	General disorders	EG0001 events1 affected499 at risk EG0013 events3 affected481 at risk
Hip Pain	General disorders	EG0000 events0 affected499 at risk EG0011 events1 affected481 at risk
Homicide	General disorders	EG0000 events0 affected499 at risk EG0011 events1 affected481 at risk
Hydrocephalus	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Hypercarbia	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Hypertensive Encephalopathy	General disorders	EG0002 events2 affected499 at risk EG0011 events1 affected481 at risk
Hypoglycemia	General disorders	EG0002 events1 affected499 at risk EG0010 events0 affected481 at risk
Hyponatremia	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Hysterectomy	General disorders	EG0005 events5 affected499 at risk EG0014 events4 affected481 at risk
Infective/Bacterial Endocarditis	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Inferior Myocardial Infarction	General disorders	EG0001 events1 affected499 at risk EG0011 events1 affected481 at risk
Inguinal Hernia	General disorders	EG0000 events0 affected499 at risk EG0011 events1 affected481 at risk
Intracerebral Haemorrhage	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Intraparenchymal Haemorrhage	General disorders	EG0001 events1 affected499 at risk EG0011 events1 affected481 at risk
Ischemic Eighth Nerve	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Ischemic Stroke	General disorders	EG00019 events18 affected499 at risk EG00131 events28 affected481 at risk
Knee Pain	General disorders	EG0001 events1 affected499 at risk EG0012 events2 affected481 at risk
Lacerations	General disorders	EG0000 events0 affected499 at risk EG0011 events1 affected481 at risk
Leukemias	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Long Q-T	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Low Back Pain	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Lung Cancer	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Melanoma	General disorders	EG0000 events0 affected499 at risk EG0011 events1 affected481 at risk
Melena	General disorders	EG0000 events0 affected499 at risk EG0011 events1 affected481 at risk
Menorrhagia	General disorders	EG0001 events1 affected499 at risk EG0012 events2 affected481 at risk
Microcytic Anemia	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Migraine	General disorders	EG00015 events12 affected499 at risk EG0019 events7 affected481 at risk
Missed Abortion	General disorders	EG0000 events0 affected499 at risk EG0012 events2 affected481 at risk
Multiple Sclerosis	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Musculoskeletal Pain	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Myocardial Infarction	General disorders	EG0006 events6 affected499 at risk EG0011 events1 affected481 at risk
Nausea	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Neck Pain	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Non-Endpoint Transient Ischemic Attack (TIA)	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Numbness	General disorders	EG0003 events3 affected499 at risk EG0014 events4 affected481 at risk
Obesity	General disorders	EG0001 events1 affected499 at risk EG0011 events1 affected481 at risk
Orthostatic Hypotension	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Osler Weber Rendu Syndrome	General disorders	EG0000 events0 affected499 at risk EG0011 events1 affected481 at risk
Osteoarthritis/Degenerative Joint Disease	General disorders	EG0004 events3 affected499 at risk EG0017 events6 affected481 at risk
Other - Preterm labor	General disorders	EG0000 events0 affected499 at risk EG0011 events1 affected481 at risk
Other - SIRS	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Other - Splenic infarcts	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Overdose	General disorders	EG0007 events4 affected499 at risk EG0015 events3 affected481 at risk
Pain	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Palpitations	General disorders	EG0001 events1 affected499 at risk EG0011 events1 affected481 at risk
Pancreatic Cancer	General disorders	EG0000 events0 affected499 at risk EG0013 events2 affected481 at risk
Panic Attack	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Paresthesia/Paraesthesia	General disorders	EG0000 events0 affected499 at risk EG0011 events1 affected481 at risk
Pericardial Effusion	General disorders	EG0001 events1 affected499 at risk EG0011 events1 affected481 at risk
Pericardial Tamponade	General disorders	EG0002 events2 affected499 at risk EG0010 events0 affected481 at risk
Pericarditis	General disorders	EG0000 events0 affected499 at risk EG0011 events1 affected481 at risk
Peripheral Arterial Occlusion	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Peripheral Venous Thrombus	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Pleurisy	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Pneumonia	General disorders	EG0009 events5 affected499 at risk EG0016 events6 affected481 at risk
Pneumonia Caused By Haemophilus Influenzae	General disorders	EG0000 events0 affected499 at risk EG0011 events1 affected481 at risk
Pneumothorax	General disorders	EG0000 events0 affected499 at risk EG0011 events1 affected481 at risk
Possible Seizure	General disorders	EG0002 events2 affected499 at risk EG0012 events2 affected481 at risk
Pre-eclampsia	General disorders	EG0000 events0 affected499 at risk EG0011 events1 affected481 at risk
Pregnancy	General disorders	EG0002 events2 affected499 at risk EG0010 events0 affected481 at risk
Pregnancy Related Symptoms	General disorders	EG0000 events0 affected499 at risk EG0011 events1 affected481 at risk
Premature Ventricular Contraction	General disorders	EG0000 events0 affected499 at risk EG0011 events1 affected481 at risk
Presyncope	General disorders	EG0000 events0 affected499 at risk EG0011 events1 affected481 at risk
Prostate Discomfort	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Pulmonary AVM	General disorders	EG0002 events2 affected499 at risk EG0010 events0 affected481 at risk
Pulmonary Congestion	General disorders	EG0002 events1 affected499 at risk EG0010 events0 affected481 at risk
Pulmonary Embolism	General disorders	EG00013 events12 affected499 at risk EG0013 events3 affected481 at risk
Radiculopathy	General disorders	EG0000 events0 affected499 at risk EG0011 events1 affected481 at risk
Residual Shunt Requiring Closure	General disorders	EG0002 events2 affected499 at risk EG0010 events0 affected481 at risk
Respiratory Illness	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Rhabdomyolysis	General disorders	EG0000 events0 affected499 at risk EG0011 events1 affected481 at risk
Right Hepatic Trocar Injury	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Rotator Cuff Tear	General disorders	EG0000 events0 affected499 at risk EG0011 events1 affected481 at risk
Seizure Disorder	General disorders	EG0001 events1 affected499 at risk EG0011 events1 affected481 at risk
Seizure/Convulsions/Epilepsy	General disorders	EG0001 events1 affected499 at risk EG0012 events2 affected481 at risk
Sepsis	General disorders	EG0008 events4 affected499 at risk EG0015 events3 affected481 at risk
Simple Partial Seizures	General disorders	EG0000 events0 affected499 at risk EG0012 events1 affected481 at risk
Sinus Bradycardia/Sinus Bradycardia (Cardiac Arrhythmia)	General disorders	EG0001 events1 affected499 at risk EG0011 events1 affected481 at risk
Spells	General disorders	EG0002 events2 affected499 at risk EG0013 events3 affected481 at risk
Spinal Stenosis	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Spontaneous Abortion	General disorders	EG0004 events3 affected499 at risk EG0011 events1 affected481 at risk
Subarachnoid Haemorrhage	General disorders	EG0000 events0 affected499 at risk EG0011 events1 affected481 at risk
Subdural Haemorrhage	General disorders	EG0000 events0 affected499 at risk EG0012 events2 affected481 at risk
Suicide Attempt	General disorders	EG0004 events4 affected499 at risk EG0011 events1 affected481 at risk
Swelling	General disorders	EG0000 events0 affected499 at risk EG0011 events1 affected481 at risk
Syncope	General disorders	EG0003 events3 affected499 at risk EG0015 events5 affected481 at risk
TEE-Related Event	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Thyroid Cancer	General disorders	EG0001 events1 affected499 at risk EG0011 events1 affected481 at risk
Thyroid Disorders	General disorders	EG0000 events0 affected499 at risk EG0011 events1 affected481 at risk
Thyrotoxicosis	General disorders	EG0000 events0 affected499 at risk EG0011 events1 affected481 at risk
Tingling	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Transient Global Amnesia	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Transient Ischemic Attack (TIA)	General disorders	EG0008 events8 affected499 at risk EG00114 events11 affected481 at risk
Trauma	General disorders	EG0004 events4 affected499 at risk EG0013 events3 affected481 at risk
Tubal Ligation	General disorders	EG0001 events1 affected499 at risk EG0011 events1 affected481 at risk
Uncontrolled Blood Sugar	General disorders	EG0000 events0 affected499 at risk EG0011 events1 affected481 at risk
Unmasking Old Stroke Symptoms	General disorders	EG0003 events3 affected499 at risk EG0012 events2 affected481 at risk
Unstable Angina	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Unsustained/Nonsustained Ventricular Tachycardia/Cardiac Arrhythmia	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Urinary Calculi	General disorders	EG0002 events2 affected499 at risk EG0012 events2 affected481 at risk
Urinary Incontinence	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Urinary Tract Infections	General disorders	EG0003 events3 affected499 at risk EG0011 events1 affected481 at risk
Uterine Fibroid	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Uterine Prolapse	General disorders	EG0001 events1 affected499 at risk EG0011 events1 affected481 at risk
VASC Bleeding	General disorders	EG0002 events2 affected499 at risk EG0010 events0 affected481 at risk
VASC Hematoma	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Vaginal Child Birth	General disorders	EG00010 events10 affected499 at risk EG0017 events5 affected481 at risk
Vaso Vagal Response	General disorders	EG0001 events1 affected499 at risk EG0011 events1 affected481 at risk
Vertigo	General disorders	EG0005 events5 affected499 at risk EG0012 events2 affected481 at risk
Viral Gastroenteritis	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Weakness	General disorders	EG0002 events1 affected499 at risk EG0010 events0 affected481 at risk
Worsening Vision	General disorders	EG0000 events0 affected499 at risk EG0011 events1 affected481 at risk
Wound Infection	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk

Other Adverse Events

Term	Organ System	Statistical Information
Abdominal Pain	General disorders	EG0003 events3 affected499 at risk EG0011 events1 affected481 at risk
Abnormal Coagulation Parameter	General disorders	EG0000 events0 affected499 at risk EG0011 events1 affected481 at risk
Abnormal Lab Value	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Acute Erosive Gastritis	General disorders	EG0000 events0 affected499 at risk EG0011 events1 affected481 at risk
Acute Pulmonary Edema	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Allergic Drug Reaction	General disorders	EG0007 events7 affected499 at risk EG0011 events1 affected481 at risk
Allergic Dye Reaction	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Anxiety	General disorders	EG0002 events2 affected499 at risk EG0011 events1 affected481 at risk
Asthma	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Atelectasis	General disorders	EG0003 events3 affected499 at risk EG0010 events0 affected481 at risk
Atrial Ectopic Beats/Premature Atrial Beats/Premature Atrial Contractions/Ectopic Atrial Rhythm	General disorders	EG00010 events10 affected499 at risk EG0010 events0 affected481 at risk
Atrial Fibrillation	General disorders	EG0007 events7 affected499 at risk EG0010 events0 affected481 at risk
Atrial Flutter	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Atrial Tachycardia	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Back Pain	General disorders	EG0005 events5 affected499 at risk EG0010 events0 affected481 at risk
Bleeding	General disorders	EG0005 events4 affected499 at risk EG0018 events8 affected481 at risk
Borderline Prolongation of QT Interval	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Bruise/Purpura Simplex	General disorders	EG00049 events46 affected499 at risk EG00128 events26 affected481 at risk
Buzzing In Chest	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Calf Pain	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Cardiac Thrombus	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Cellulitis	General disorders	EG0002 events2 affected499 at risk EG0010 events0 affected481 at risk
Chest Pain	General disorders	EG00048 events47 affected499 at risk EG0011 events1 affected481 at risk
Chest Tightness	General disorders	EG0003 events3 affected499 at risk EG0010 events0 affected481 at risk
Chronic Obstructive Pulmonary Disease (COPD)	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Contact Dermatitis	General disorders	EG0000 events0 affected499 at risk EG0011 events1 affected481 at risk
Cough	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Couplet	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Deep Vein/Venous Thrombosis	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Dental Trauma	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Device Malposition or Malfunction	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Diarrhea	General disorders	EG0001 events1 affected499 at risk EG0013 events3 affected481 at risk
Difficulty Catching Breath	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Dizziness	General disorders	EG0004 events4 affected499 at risk EG0010 events0 affected481 at risk
Drug Rash	General disorders	EG0002 events2 affected499 at risk EG0010 events0 affected481 at risk
Drug Side Effect	General disorders	EG0004 events4 affected499 at risk EG0015 events5 affected481 at risk
Dyspepsia	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Dyspnea	General disorders	EG0007 events7 affected499 at risk EG0010 events0 affected481 at risk
Emesis/Vomiting	General disorders	EG0003 events3 affected499 at risk EG0010 events0 affected481 at risk
Epistaxis	General disorders	EG0007 events7 affected499 at risk EG0016 events6 affected481 at risk
Esophagitis	General disorders	EG0000 events0 affected499 at risk EG0011 events1 affected481 at risk
Fainting/Blackout	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
First Degree Heart/AV Block/Cardiac Arrhythmia - 1st degree AV Block	General disorders	EG0003 events3 affected499 at risk EG0010 events0 affected481 at risk
Flushing	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Gastritis	General disorders	EG0003 events3 affected499 at risk EG0012 events2 affected481 at risk
Gastroenteritis	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Gastroesophageal Reflux Disease	General disorders	EG0001 events1 affected499 at risk EG0012 events2 affected481 at risk
Gastrointestinal Bleeding	General disorders	EG0001 events1 affected499 at risk EG0012 events2 affected481 at risk
Gastrointestinal Illness	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Gingival Bleeding	General disorders	EG0001 events1 affected499 at risk EG0011 events1 affected481 at risk
Headache	General disorders	EG0008 events8 affected499 at risk EG0018 events8 affected481 at risk
Heartburn	General disorders	EG0002 events2 affected499 at risk EG0010 events0 affected481 at risk
Heaviness of Legs	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Hematochezia	General disorders	EG0000 events0 affected499 at risk EG0012 events2 affected481 at risk
Hematoma	General disorders	EG0004 events4 affected499 at risk EG0012 events2 affected481 at risk
Hematuria	General disorders	EG0000 events0 affected499 at risk EG0012 events2 affected481 at risk
Hemoptysis	General disorders	EG0000 events0 affected499 at risk EG0011 events1 affected481 at risk
Hypotension	General disorders	EG0005 events5 affected499 at risk EG0010 events0 affected481 at risk
Hypoxemia	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Incomplete Right Bundle Branch Block	General disorders	EG0003 events3 affected499 at risk EG0010 events0 affected481 at risk
Increased Shunt	General disorders	EG0003 events3 affected499 at risk EG0010 events0 affected481 at risk
Instillation Site Foreign Body Sensation	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Leg Cramps	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Low Back Pain	General disorders	EG0005 events5 affected499 at risk EG0010 events0 affected481 at risk
Low Hematocrit	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Menorrhagia	General disorders	EG0002 events2 affected499 at risk EG0015 events5 affected481 at risk
Meralgia Paraesthetica	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Mid-Sternal Chest Pressure	General disorders	EG0003 events3 affected499 at risk EG0010 events0 affected481 at risk
Migraine	General disorders	EG0002 events2 affected499 at risk EG0010 events0 affected481 at risk
Musculoskeletal Pain	General disorders	EG0003 events3 affected499 at risk EG0010 events0 affected481 at risk
Nausea	General disorders	EG00011 events11 affected499 at risk EG0010 events0 affected481 at risk
Non-Specific EKG Change	General disorders	EG0003 events3 affected499 at risk EG0010 events0 affected481 at risk
Pain	General disorders	EG0005 events5 affected499 at risk EG0010 events0 affected481 at risk
Pain Due to a Catheter Drainage Tube	General disorders	EG0002 events2 affected499 at risk EG0010 events0 affected481 at risk
Palpitations	General disorders	EG00044 events42 affected499 at risk EG0010 events0 affected481 at risk
Paresthesia/Paraesthesia	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Paroxysmal Atrial Fibrillation	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Paroxysmal Supraventricular Tachycardia	General disorders	EG0004 events4 affected499 at risk EG0010 events0 affected481 at risk
Peptic Ulcer Disease	General disorders	EG0000 events0 affected499 at risk EG0011 events1 affected481 at risk
Pinching Sensation in Chest	General disorders	EG0002 events2 affected499 at risk EG0010 events0 affected481 at risk
Pleural Effusion	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Post-Menopausal Bleeding	General disorders	EG0000 events0 affected499 at risk EG0011 events1 affected481 at risk
Presyncope	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Pruritus/Itching	General disorders	EG0003 events3 affected499 at risk EG0011 events1 affected481 at risk
Pulmonary Congestion	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Right Axis Deviation	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Right Bundle Branch Block/Complete Right Bundle Branch Block	General disorders	EG0002 events2 affected499 at risk EG0010 events0 affected481 at risk
ST Segment Changes	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
ST-T Wave Abnormality	General disorders	EG0003 events3 affected499 at risk EG0010 events0 affected481 at risk
Sick Sinus Syndrome	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Sinus Bradycardia/Sinus Bradycardia (Cardiac Arrhythmia)	General disorders	EG00020 events19 affected499 at risk EG0010 events0 affected481 at risk
Sinus Tachycardia	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Sore Throat	General disorders	EG0003 events3 affected499 at risk EG0010 events0 affected481 at risk
T-Wave Abnormalities	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
TEE-Related Event	General disorders	EG00010 events10 affected499 at risk EG0011 events1 affected481 at risk
Trigeminy	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
Unsustained/Nonsustained Ventricular Tachycardia/Cardiac Arrhythmia	General disorders	EG0004 events4 affected499 at risk EG0010 events0 affected481 at risk
VASC Bleeding	General disorders	EG00016 events16 affected499 at risk EG0010 events0 affected481 at risk
VASC Bruise	General disorders	EG0001 events1 affected499 at risk EG0010 events0 affected481 at risk
VASC Hematoma	General disorders	EG00036 events36 affected499 at risk EG0011 events1 affected481 at risk
VASC Pain	General disorders	EG00032 events32 affected499 at risk EG0010 events0 affected481 at risk
Vaso Vagal Response	General disorders	EG0006 events6 affected499 at risk EG0011 events1 affected481 at risk

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D006344	Heart Septal Defects, Atrial
D006343	Heart Septal Defects
D006330	Heart Defects, Congenital
D018376	Cardiovascular Abnormalities
D006331	Heart Diseases
D000013	Congenital Abnormalities
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities

ID	Title	Description
BG000	Device	AMPLATZER PFO Occluder: patent foramen ovale closure device
BG001	Medical Management	Aspirin alone, Coumadin alone, Clopidogrel alone, or Aspirin combined with dipyridamole
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Device	AMPLATZER PFO Occluder: patent foramen ovale closure device	7	499	201	499	285	499
EG001	Medical Management	Aspirin alone, Coumadin alone, Clopidogrel alone, or Aspirin combined with dipyridamole	11	481	173	481	70	481

ID	Term
D000083242	Ischemic Stroke
D020521	Stroke
D054092	Foramen Ovale, Patent