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Patent Foramen Ovale Closure or Medical Therapy After Stroke - RESPECT Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00465270
Recruitment Status : Completed
First Posted : April 24, 2007
Results First Posted : September 3, 2018
Last Update Posted : September 3, 2018
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Cryptogenic Stroke
Interventions Device: AMPLATZER PFO Occluder
Other: Standard of Care - Medical Management
Enrollment 980
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Device Medical Management
Hide Arm/Group Description AMPLATZER PFO Occluder: patent foramen ovale closure device Aspirin alone, Coumadin alone, Clopidogrel alone, or Aspirin combined with dipyridamole.
Period Title: Overall Study
Started 499 481
Completed 395 321
Not Completed 104 160
Reason Not Completed
Death             7             11
Withdrawal by Subject             34             78
Lost to Follow-up             60             67
Investigator request             3             4
Arm/Group Title Device Medical Management Total
Hide Arm/Group Description AMPLATZER PFO Occluder: patent foramen ovale closure device Aspirin alone, Coumadin alone, Clopidogrel alone, or Aspirin combined with dipyridamole Total of all reporting groups
Overall Number of Baseline Participants 499 481 980
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 499 participants 481 participants 980 participants
45.7  (9.7) 46.2  (10.0) 45.9  (9.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 499 participants 481 participants 980 participants
Female
231
  46.3%
213
  44.3%
444
  45.3%
Male
268
  53.7%
268
  55.7%
536
  54.7%
1.Primary Outcome
Title Composite of Recurrent Nonfatal Ischemic Stroke, Fatal Ischemic Stroke, or Early Death After Randomization
Hide Description

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.

Time Frame 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All primary endpoints that occurred in the trial were recurrent non-fatal ischemic strokes.
Arm/Group Title Device Medical Management
Hide Arm/Group Description:
AMPLATZER PFO Occluder: patent foramen ovale closure device
Aspirin alone, Coumadin alone, Clopidogrel alone, or Aspirin combined with dipyridamole
Overall Number of Participants Analyzed 499 481
Measure Type: Count of Participants
Unit of Measure: Participants
9
   1.8%
16
   3.3%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Device, Medical Management
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.08
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.49
Confidence Interval (2-Sided) 95%
0.22 to 1.11
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Rate of Complete PFO Closure (Assessed by TEE Bubble Study) at the 6-month Follow-up in the Device Group
Hide Description [Not Specified]
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only subjects with complete PFO closure data at 6-months were analyzed.
Arm/Group Title Device
Hide Arm/Group Description:
AMPLATZER PFO Occluder: patent foramen ovale closure device
Overall Number of Participants Analyzed 349
Measure Type: Count of Participants
Unit of Measure: Participants
249
  71.3%
3.Post-Hoc Outcome
Title Rate of Recurrent Nonfatal Stroke, Post-randomization Death, and Fatal Ischemic Stroke Through Long Term Follow-up
Hide Description [Not Specified]
Time Frame Long Term Follow-up, median of 5.9 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Device Medical Management
Hide Arm/Group Description:
AMPLATZER PFO Occluder: patent foramen ovale closure device
Aspirin alone, Coumadin alone, Clopidogrel alone, or Aspirin combined with dipyridamole
Overall Number of Participants Analyzed 499 481
Measure Type: Count of Participants
Unit of Measure: Participants
18
   3.6%
28
   5.8%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Device, Medical Management
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.046
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.55
Confidence Interval (2-Sided) 95%
0.31 to 0.999
Estimation Comments [Not Specified]
Time Frame The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Device Medical Management
Hide Arm/Group Description AMPLATZER PFO Occluder: patent foramen ovale closure device Aspirin alone, Coumadin alone, Clopidogrel alone, or Aspirin combined with dipyridamole
All-Cause Mortality
Device Medical Management
Affected / at Risk (%) Affected / at Risk (%)
Total   7/499 (1.40%)      11/481 (2.29%)    
Show Serious Adverse Events Hide Serious Adverse Events
Device Medical Management
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   201/499 (40.28%)      173/481 (35.97%)    
General disorders     
ASD  1/499 (0.20%)  1 0/481 (0.00%)  0
Abdominal Pain  2/499 (0.40%)  2 2/481 (0.42%)  3
Abnormal Lab Value  0/499 (0.00%)  0 1/481 (0.21%)  1
Acute Bacterial Endocarditis (ABE)  1/499 (0.20%)  1 0/481 (0.00%)  0
Acute Bronchitis  1/499 (0.20%)  1 0/481 (0.00%)  0
Acute Erosive Gastritis  1/499 (0.20%)  1 0/481 (0.00%)  0
Acute Gastroenteritis  2/499 (0.40%)  2 0/481 (0.00%)  0
Acute Pancreatitis  2/499 (0.40%)  2 0/481 (0.00%)  0
Acute Peritonitis  0/499 (0.00%)  0 1/481 (0.21%)  1
Acute Pulmonary Edema  0/499 (0.00%)  0 1/481 (0.21%)  1
Acute Renal Failure  1/499 (0.20%)  1 1/481 (0.21%)  1
Acute Subdural Hematoma  1/499 (0.20%)  1 0/481 (0.00%)  0
Alcohol Intoxication  1/499 (0.20%)  1 0/481 (0.00%)  0
Allergic Device Reaction  0/499 (0.00%)  0 1/481 (0.21%)  1
Allergic Drug Reaction  2/499 (0.40%)  2 0/481 (0.00%)  0
Altered Sensorium  1/499 (0.20%)  1 0/481 (0.00%)  0
Anemias  4/499 (0.80%)  4 0/481 (0.00%)  0
Angina Pectoris  1/499 (0.20%)  1 1/481 (0.21%)  1
Ankle Fracture  1/499 (0.20%)  1 0/481 (0.00%)  0
Anterior Meniscus Tear  0/499 (0.00%)  0 1/481 (0.21%)  1
Anxiety  0/499 (0.00%)  0 2/481 (0.42%)  2
Aortic Aneurysms  2/499 (0.40%)  2 0/481 (0.00%)  0
Appendicitis  4/499 (0.80%)  4 2/481 (0.42%)  2
Arm Fracture  2/499 (0.40%)  2 1/481 (0.21%)  1
Arterial Hypertension/Hypertension  4/499 (0.80%)  4 1/481 (0.21%)  1
Arthritis  2/499 (0.40%)  2 0/481 (0.00%)  0
Asthma  2/499 (0.40%)  2 1/481 (0.21%)  1
Atrial Fibrillation  6/499 (1.20%)  8 4/481 (0.83%)  4
Atrial Flutter  1/499 (0.20%)  1 0/481 (0.00%)  0
Back Pain  1/499 (0.20%)  1 2/481 (0.42%)  2
Bacterial Infections  0/499 (0.00%)  0 3/481 (0.62%)  3
Bacterial Infections of the Skin  2/499 (0.40%)  3 1/481 (0.21%)  1
Benign Mass  0/499 (0.00%)  0 1/481 (0.21%)  1
Bipolar Disorder  2/499 (0.40%)  2 0/481 (0.00%)  0
Birth Defect  0/499 (0.00%)  0 1/481 (0.21%)  1
Bleeding  3/499 (0.60%)  3 1/481 (0.21%)  1
Blood Loss  0/499 (0.00%)  0 1/481 (0.21%)  1
Bowel Obstruction  4/499 (0.80%)  5 2/481 (0.42%)  2
Brain Abcess  0/499 (0.00%)  0 1/481 (0.21%)  1
Brain Tumor  0/499 (0.00%)  0 2/481 (0.42%)  2
Breast Cancer  6/499 (1.20%)  6 2/481 (0.42%)  2
Bronchiolitis  0/499 (0.00%)  0 1/481 (0.21%)  1
Bronchitis  0/499 (0.00%)  0 1/481 (0.21%)  1
Burns  1/499 (0.20%)  1 1/481 (0.21%)  1
Caesarean Section  5/499 (1.00%)  5 3/481 (0.62%)  4
Cancer  5/499 (1.00%)  6 7/481 (1.46%)  7
Cardiac Arrest  1/499 (0.20%)  1 3/481 (0.62%)  3
Cardiac Perforation  1/499 (0.20%)  1 0/481 (0.00%)  0
Cardiac Thrombus  2/499 (0.40%)  2 0/481 (0.00%)  0
Cardiomyopathy  1/499 (0.20%)  1 0/481 (0.00%)  0
Cellulitis  2/499 (0.40%)  3 6/481 (1.25%)  6
Cerebral Aneurysm  0/499 (0.00%)  0 2/481 (0.42%)  2
Cerebral Infarct – Asymptomatic***  0/499 (0.00%)  0 2/481 (0.42%)  2
Cerebrospinal Fluid (CSF) Leak  0/499 (0.00%)  0 1/481 (0.21%)  1
Cervical Spondylosis  1/499 (0.20%)  1 0/481 (0.00%)  0
Cervical Stenosis  2/499 (0.40%)  2 1/481 (0.21%)  1
Chest Pain  18/499 (3.61%)  19 15/481 (3.12%)  16
Chest Tightness  1/499 (0.20%)  1 0/481 (0.00%)  0
Chills/Rigors  1/499 (0.20%)  1 0/481 (0.00%)  0
Cholecystitis  1/499 (0.20%)  1 5/481 (1.04%)  5
Choledochal Cysts  1/499 (0.20%)  1 0/481 (0.00%)  0
Choledocholithiaisis  1/499 (0.20%)  1 0/481 (0.00%)  0
Cholelithiasis  3/499 (0.60%)  3 0/481 (0.00%)  0
Chronic Obstructive Airway Disorders  0/499 (0.00%)  0 1/481 (0.21%)  1
Chronic Obstructive Pulmonary Disease (COPD)  0/499 (0.00%)  0 1/481 (0.21%)  1
Chronic Pancreatitis  1/499 (0.20%)  2 0/481 (0.00%)  0
Closed Head Injury  1/499 (0.20%)  1 1/481 (0.21%)  1
Colitis  3/499 (0.60%)  3 2/481 (0.42%)  2
Colon Cancer  1/499 (0.20%)  3 1/481 (0.21%)  1
Common Cold/Upper Respiratory Tract Infection  0/499 (0.00%)  0 1/481 (0.21%)  1
Compartment Syndrome  1/499 (0.20%)  1 0/481 (0.00%)  0
Complex Partial Seizures  1/499 (0.20%)  1 0/481 (0.00%)  0
Confusion  0/499 (0.00%)  0 2/481 (0.42%)  3
Congestive Heart Failure  1/499 (0.20%)  1 0/481 (0.00%)  0
Conversion Reaction  2/499 (0.40%)  3 0/481 (0.00%)  0
Coronary Artery Disease  3/499 (0.60%)  3 2/481 (0.42%)  2
Cutaneous Abcesses  2/499 (0.40%)  2 1/481 (0.21%)  1
Deep Vein/Venous Thrombosis  5/499 (1.00%)  5 1/481 (0.21%)  1
Dehydration  0/499 (0.00%)  0 2/481 (0.42%)  2
Delirium  0/499 (0.00%)  0 1/481 (0.21%)  1
Depression  2/499 (0.40%)  3 4/481 (0.83%)  5
Disc Protrusion  1/499 (0.20%)  1 0/481 (0.00%)  0
Diverticulitis  3/499 (0.60%)  3 1/481 (0.21%)  1
Dizziness  2/499 (0.40%)  3 2/481 (0.42%)  2
Drug Side Effect  0/499 (0.00%)  0 1/481 (0.21%)  1
Duodenal Cancer  0/499 (0.00%)  0 1/481 (0.21%)  1
Dysarthria/Slurred Speech  1/499 (0.20%)  1 0/481 (0.00%)  0
Dyspnea  3/499 (0.60%)  3 1/481 (0.21%)  1
Elective Surgery  26/499 (5.21%)  32 17/481 (3.53%)  20
Emesis/Vomiting  0/499 (0.00%)  0 1/481 (0.21%)  1
Encephalopathy  0/499 (0.00%)  0 2/481 (0.42%)  2
Eye Lacerations  0/499 (0.00%)  0 1/481 (0.21%)  1
Failure to Thrive  1/499 (0.20%)  1 0/481 (0.00%)  0
Fall  3/499 (0.60%)  3 2/481 (0.42%)  2
Fenestrated Atrial Septum  2/499 (0.40%)  2 0/481 (0.00%)  0
Fever  1/499 (0.20%)  2 0/481 (0.00%)  0
Fracture  3/499 (0.60%)  4 0/481 (0.00%)  0
Gastritis  0/499 (0.00%)  0 1/481 (0.21%)  1
Gastroenteritis  1/499 (0.20%)  1 0/481 (0.00%)  0
Gastroesophageal Reflux Disease  0/499 (0.00%)  0 2/481 (0.42%)  2
Gastrointestinal Bleeding  6/499 (1.20%)  6 4/481 (0.83%)  4
Generalized Seizures  1/499 (0.20%)  1 1/481 (0.21%)  1
Generalized Tonic-Clonic Seizures  1/499 (0.20%)  1 1/481 (0.21%)  1
Headache  4/499 (0.80%)  4 1/481 (0.21%)  1
Hematoma  1/499 (0.20%)  2 2/481 (0.42%)  2
Hemiparesis/Weakness  2/499 (0.40%)  2 0/481 (0.00%)  0
Hemorrhagic Stroke  0/499 (0.00%)  0 1/481 (0.21%)  1
Hepatic and Biliary Disorders  1/499 (0.20%)  1 0/481 (0.00%)  0
Hernia  0/499 (0.00%)  0 1/481 (0.21%)  1
Herniated Disc  2/499 (0.40%)  2 0/481 (0.00%)  0
Hip Dislocation  0/499 (0.00%)  0 1/481 (0.21%)  2
Hip Fracture  1/499 (0.20%)  1 3/481 (0.62%)  3
Hip Pain  0/499 (0.00%)  0 1/481 (0.21%)  1
Homicide  0/499 (0.00%)  0 1/481 (0.21%)  1
Hydrocephalus  1/499 (0.20%)  1 0/481 (0.00%)  0
Hypercarbia  1/499 (0.20%)  1 0/481 (0.00%)  0
Hypertensive Encephalopathy  2/499 (0.40%)  2 1/481 (0.21%)  1
Hypoglycemia  1/499 (0.20%)  2 0/481 (0.00%)  0
Hyponatremia  1/499 (0.20%)  1 0/481 (0.00%)  0
Hysterectomy  5/499 (1.00%)  5 4/481 (0.83%)  4
Infective/Bacterial Endocarditis  1/499 (0.20%)  1 0/481 (0.00%)  0
Inferior Myocardial Infarction  1/499 (0.20%)  1 1/481 (0.21%)  1
Inguinal Hernia  0/499 (0.00%)  0 1/481 (0.21%)  1
Intracerebral Haemorrhage  1/499 (0.20%)  1 0/481 (0.00%)  0
Intraparenchymal Haemorrhage  1/499 (0.20%)  1 1/481 (0.21%)  1
Ischemic Eighth Nerve  1/499 (0.20%)  1 0/481 (0.00%)  0
Ischemic Stroke  18/499 (3.61%)  19 28/481 (5.82%)  31
Knee Pain  1/499 (0.20%)  1 2/481 (0.42%)  2
Lacerations  0/499 (0.00%)  0 1/481 (0.21%)  1
Leukemias  1/499 (0.20%)  1 0/481 (0.00%)  0
Long Q-T  1/499 (0.20%)  1 0/481 (0.00%)  0
Low Back Pain  1/499 (0.20%)  1 0/481 (0.00%)  0
Lung Cancer  1/499 (0.20%)  1 0/481 (0.00%)  0
Melanoma  0/499 (0.00%)  0 1/481 (0.21%)  1
Melena  0/499 (0.00%)  0 1/481 (0.21%)  1
Menorrhagia  1/499 (0.20%)  1 2/481 (0.42%)  2
Microcytic Anemia  1/499 (0.20%)  1 0/481 (0.00%)  0
Migraine  12/499 (2.40%)  15 7/481 (1.46%)  9
Missed Abortion  0/499 (0.00%)  0 2/481 (0.42%)  2
Multiple Sclerosis  1/499 (0.20%)  1 0/481 (0.00%)  0
Musculoskeletal Pain  1/499 (0.20%)  1 0/481 (0.00%)  0
Myocardial Infarction  6/499 (1.20%)  6 1/481 (0.21%)  1
Nausea  1/499 (0.20%)  1 0/481 (0.00%)  0
Neck Pain  1/499 (0.20%)  1 0/481 (0.00%)  0
Non-Endpoint Transient Ischemic Attack (TIA)  1/499 (0.20%)  1 0/481 (0.00%)  0
Numbness  3/499 (0.60%)  3 4/481 (0.83%)  4
Obesity  1/499 (0.20%)  1 1/481 (0.21%)  1
Orthostatic Hypotension  1/499 (0.20%)  1 0/481 (0.00%)  0
Osler Weber Rendu Syndrome  0/499 (0.00%)  0 1/481 (0.21%)  1
Osteoarthritis/Degenerative Joint Disease  3/499 (0.60%)  4 6/481 (1.25%)  7
Other - Preterm labor  0/499 (0.00%)  0 1/481 (0.21%)  1
Other - SIRS  1/499 (0.20%)  1 0/481 (0.00%)  0
Other - Splenic infarcts  1/499 (0.20%)  1 0/481 (0.00%)  0
Overdose  4/499 (0.80%)  7 3/481 (0.62%)  5
Pain  1/499 (0.20%)  1 0/481 (0.00%)  0
Palpitations  1/499 (0.20%)  1 1/481 (0.21%)  1
Pancreatic Cancer  0/499 (0.00%)  0 2/481 (0.42%)  3
Panic Attack  1/499 (0.20%)  1 0/481 (0.00%)  0
Paresthesia/Paraesthesia  0/499 (0.00%)  0 1/481 (0.21%)  1
Pericardial Effusion  1/499 (0.20%)  1 1/481 (0.21%)  1
Pericardial Tamponade  2/499 (0.40%)  2 0/481 (0.00%)  0
Pericarditis  0/499 (0.00%)  0 1/481 (0.21%)  1
Peripheral Arterial Occlusion  1/499 (0.20%)  1 0/481 (0.00%)  0
Peripheral Venous Thrombus  1/499 (0.20%)  1 0/481 (0.00%)  0
Pleurisy  1/499 (0.20%)  1 0/481 (0.00%)  0
Pneumonia  5/499 (1.00%)  9 6/481 (1.25%)  6
Pneumonia Caused By Haemophilus Influenzae  0/499 (0.00%)  0 1/481 (0.21%)  1
Pneumothorax  0/499 (0.00%)  0 1/481 (0.21%)  1
Possible Seizure  2/499 (0.40%)  2 2/481 (0.42%)  2
Pre-eclampsia  0/499 (0.00%)  0 1/481 (0.21%)  1
Pregnancy  2/499 (0.40%)  2 0/481 (0.00%)  0
Pregnancy Related Symptoms  0/499 (0.00%)  0 1/481 (0.21%)  1
Premature Ventricular Contraction  0/499 (0.00%)  0 1/481 (0.21%)  1
Presyncope  0/499 (0.00%)  0 1/481 (0.21%)  1
Prostate Discomfort  1/499 (0.20%)  1 0/481 (0.00%)  0
Pulmonary AVM  2/499 (0.40%)  2 0/481 (0.00%)  0
Pulmonary Congestion  1/499 (0.20%)  2 0/481 (0.00%)  0
Pulmonary Embolism  12/499 (2.40%)  13 3/481 (0.62%)  3
Radiculopathy  0/499 (0.00%)  0 1/481 (0.21%)  1
Residual Shunt Requiring Closure  2/499 (0.40%)  2 0/481 (0.00%)  0
Respiratory Illness  1/499 (0.20%)  1 0/481 (0.00%)  0
Rhabdomyolysis  0/499 (0.00%)  0 1/481 (0.21%)  1
Right Hepatic Trocar Injury  1/499 (0.20%)  1 0/481 (0.00%)  0
Rotator Cuff Tear  0/499 (0.00%)  0 1/481 (0.21%)  1
Seizure Disorder  1/499 (0.20%)  1 1/481 (0.21%)  1
Seizure/Convulsions/Epilepsy  1/499 (0.20%)  1 2/481 (0.42%)  2
Sepsis  4/499 (0.80%)  8 3/481 (0.62%)  5
Simple Partial Seizures  0/499 (0.00%)  0 1/481 (0.21%)  2
Sinus Bradycardia/Sinus Bradycardia (Cardiac Arrhythmia)  1/499 (0.20%)  1 1/481 (0.21%)  1
Spells  2/499 (0.40%)  2 3/481 (0.62%)  3
Spinal Stenosis  1/499 (0.20%)  1 0/481 (0.00%)  0
Spontaneous Abortion  3/499 (0.60%)  4 1/481 (0.21%)  1
Subarachnoid Haemorrhage  0/499 (0.00%)  0 1/481 (0.21%)  1
Subdural Haemorrhage  0/499 (0.00%)  0 2/481 (0.42%)  2
Suicide Attempt  4/499 (0.80%)  4 1/481 (0.21%)  1
Swelling  0/499 (0.00%)  0 1/481 (0.21%)  1
Syncope  3/499 (0.60%)  3 5/481 (1.04%)  5
TEE-Related Event  1/499 (0.20%)  1 0/481 (0.00%)  0
Thyroid Cancer  1/499 (0.20%)  1 1/481 (0.21%)  1
Thyroid Disorders  0/499 (0.00%)  0 1/481 (0.21%)  1
Thyrotoxicosis  0/499 (0.00%)  0 1/481 (0.21%)  1
Tingling  1/499 (0.20%)  1 0/481 (0.00%)  0
Transient Global Amnesia  1/499 (0.20%)  1 0/481 (0.00%)  0
Transient Ischemic Attack (TIA)  8/499 (1.60%)  8 11/481 (2.29%)  14
Trauma  4/499 (0.80%)  4 3/481 (0.62%)  3
Tubal Ligation  1/499 (0.20%)  1 1/481 (0.21%)  1
Uncontrolled Blood Sugar  0/499 (0.00%)  0 1/481 (0.21%)  1
Unmasking Old Stroke Symptoms  3/499 (0.60%)  3 2/481 (0.42%)  2
Unstable Angina  1/499 (0.20%)  1 0/481 (0.00%)  0
Unsustained/Nonsustained Ventricular Tachycardia/Cardiac Arrhythmia  1/499 (0.20%)  1 0/481 (0.00%)  0
Urinary Calculi  2/499 (0.40%)  2 2/481 (0.42%)  2
Urinary Incontinence  1/499 (0.20%)  1 0/481 (0.00%)  0
Urinary Tract Infections  3/499 (0.60%)  3 1/481 (0.21%)  1
Uterine Fibroid  1/499 (0.20%)  1 0/481 (0.00%)  0
Uterine Prolapse  1/499 (0.20%)  1 1/481 (0.21%)  1
VASC Bleeding  2/499 (0.40%)  2 0/481 (0.00%)  0
VASC Hematoma  1/499 (0.20%)  1 0/481 (0.00%)  0
Vaginal Child Birth  10/499 (2.00%)  10 5/481 (1.04%)  7
Vaso Vagal Response  1/499 (0.20%)  1 1/481 (0.21%)  1
Vertigo  5/499 (1.00%)  5 2/481 (0.42%)  2
Viral Gastroenteritis  1/499 (0.20%)  1 0/481 (0.00%)  0
Weakness  1/499 (0.20%)  2 0/481 (0.00%)  0
Worsening Vision  0/499 (0.00%)  0 1/481 (0.21%)  1
Wound Infection  1/499 (0.20%)  1 0/481 (0.00%)  0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Device Medical Management
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   285/499 (57.11%)      70/481 (14.55%)    
General disorders     
Abdominal Pain  3/499 (0.60%)  3 1/481 (0.21%)  1
Abnormal Coagulation Parameter  0/499 (0.00%)  0 1/481 (0.21%)  1
Abnormal Lab Value  1/499 (0.20%)  1 0/481 (0.00%)  0
Acute Erosive Gastritis  0/499 (0.00%)  0 1/481 (0.21%)  1
Acute Pulmonary Edema  1/499 (0.20%)  1 0/481 (0.00%)  0
Allergic Drug Reaction  7/499 (1.40%)  7 1/481 (0.21%)  1
Allergic Dye Reaction  1/499 (0.20%)  1 0/481 (0.00%)  0
Anxiety  2/499 (0.40%)  2 1/481 (0.21%)  1
Asthma  1/499 (0.20%)  1 0/481 (0.00%)  0
Atelectasis  3/499 (0.60%)  3 0/481 (0.00%)  0
Atrial Ectopic Beats/Premature Atrial Beats/Premature Atrial Contractions/Ectopic Atrial Rhythm  10/499 (2.00%)  10 0/481 (0.00%)  0
Atrial Fibrillation  7/499 (1.40%)  7 0/481 (0.00%)  0
Atrial Flutter  1/499 (0.20%)  1 0/481 (0.00%)  0
Atrial Tachycardia  1/499 (0.20%)  1 0/481 (0.00%)  0
Back Pain  5/499 (1.00%)  5 0/481 (0.00%)  0
Bleeding  4/499 (0.80%)  5 8/481 (1.66%)  8
Borderline Prolongation of QT Interval  1/499 (0.20%)  1 0/481 (0.00%)  0
Bruise/Purpura Simplex  46/499 (9.22%)  49 26/481 (5.41%)  28
Buzzing In Chest  1/499 (0.20%)  1 0/481 (0.00%)  0
Calf Pain  1/499 (0.20%)  1 0/481 (0.00%)  0
Cardiac Thrombus  1/499 (0.20%)  1 0/481 (0.00%)  0
Cellulitis  2/499 (0.40%)  2 0/481 (0.00%)  0
Chest Pain  47/499 (9.42%)  48 1/481 (0.21%)  1
Chest Tightness  3/499 (0.60%)  3 0/481 (0.00%)  0
Chronic Obstructive Pulmonary Disease (COPD)  1/499 (0.20%)  1 0/481 (0.00%)  0
Contact Dermatitis  0/499 (0.00%)  0 1/481 (0.21%)  1
Cough  1/499 (0.20%)  1 0/481 (0.00%)  0
Couplet  1/499 (0.20%)  1 0/481 (0.00%)  0
Deep Vein/Venous Thrombosis  1/499 (0.20%)  1 0/481 (0.00%)  0
Dental Trauma  1/499 (0.20%)  1 0/481 (0.00%)  0
Device Malposition or Malfunction  1/499 (0.20%)  1 0/481 (0.00%)  0
Diarrhea  1/499 (0.20%)  1 3/481 (0.62%)  3
Difficulty Catching Breath  1/499 (0.20%)  1 0/481 (0.00%)  0
Dizziness  4/499 (0.80%)  4 0/481 (0.00%)  0
Drug Rash  2/499 (0.40%)  2 0/481 (0.00%)  0
Drug Side Effect  4/499 (0.80%)  4 5/481 (1.04%)  5
Dyspepsia  1/499 (0.20%)  1 0/481 (0.00%)  0
Dyspnea  7/499 (1.40%)  7 0/481 (0.00%)  0
Emesis/Vomiting  3/499 (0.60%)  3 0/481 (0.00%)  0
Epistaxis  7/499 (1.40%)  7 6/481 (1.25%)  6
Esophagitis  0/499 (0.00%)  0 1/481 (0.21%)  1
Fainting/Blackout  1/499 (0.20%)  1 0/481 (0.00%)  0
First Degree Heart/AV Block/Cardiac Arrhythmia - 1st degree AV Block  3/499 (0.60%)  3 0/481 (0.00%)  0
Flushing  1/499 (0.20%)  1 0/481 (0.00%)  0
Gastritis  3/499 (0.60%)  3 2/481 (0.42%)  2
Gastroenteritis  1/499 (0.20%)  1 0/481 (0.00%)  0
Gastroesophageal Reflux Disease  1/499 (0.20%)  1 2/481 (0.42%)  2
Gastrointestinal Bleeding  1/499 (0.20%)  1 2/481 (0.42%)  2
Gastrointestinal Illness  1/499 (0.20%)  1 0/481 (0.00%)  0
Gingival Bleeding  1/499 (0.20%)  1 1/481 (0.21%)  1
Headache  8/499 (1.60%)  8 8/481 (1.66%)  8
Heartburn  2/499 (0.40%)  2 0/481 (0.00%)  0
Heaviness of Legs  1/499 (0.20%)  1 0/481 (0.00%)  0
Hematochezia  0/499 (0.00%)  0 2/481 (0.42%)  2
Hematoma  4/499 (0.80%)  4 2/481 (0.42%)  2
Hematuria  0/499 (0.00%)  0 2/481 (0.42%)  2
Hemoptysis  0/499 (0.00%)  0 1/481 (0.21%)  1
Hypotension  5/499 (1.00%)  5 0/481 (0.00%)  0
Hypoxemia  1/499 (0.20%)  1 0/481 (0.00%)  0
Incomplete Right Bundle Branch Block  3/499 (0.60%)  3 0/481 (0.00%)  0
Increased Shunt  3/499 (0.60%)  3 0/481 (0.00%)  0
Instillation Site Foreign Body Sensation  1/499 (0.20%)  1 0/481 (0.00%)  0
Leg Cramps  1/499 (0.20%)  1 0/481 (0.00%)  0
Low Back Pain  5/499 (1.00%)  5 0/481 (0.00%)  0
Low Hematocrit  1/499 (0.20%)  1 0/481 (0.00%)  0
Menorrhagia  2/499 (0.40%)  2 5/481 (1.04%)  5
Meralgia Paraesthetica  1/499 (0.20%)  1 0/481 (0.00%)  0
Mid-Sternal Chest Pressure  3/499 (0.60%)  3 0/481 (0.00%)  0
Migraine  2/499 (0.40%)  2 0/481 (0.00%)  0
Musculoskeletal Pain  3/499 (0.60%)  3 0/481 (0.00%)  0
Nausea  11/499 (2.20%)  11 0/481 (0.00%)  0
Non-Specific EKG Change  3/499 (0.60%)  3 0/481 (0.00%)  0
Pain  5/499 (1.00%)  5 0/481 (0.00%)  0
Pain Due to a Catheter Drainage Tube  2/499 (0.40%)  2 0/481 (0.00%)  0
Palpitations  42/499 (8.42%)  44 0/481 (0.00%)  0
Paresthesia/Paraesthesia  1/499 (0.20%)  1 0/481 (0.00%)  0
Paroxysmal Atrial Fibrillation  1/499 (0.20%)  1 0/481 (0.00%)  0
Paroxysmal Supraventricular Tachycardia  4/499 (0.80%)  4 0/481 (0.00%)  0
Peptic Ulcer Disease  0/499 (0.00%)  0 1/481 (0.21%)  1
Pinching Sensation in Chest  2/499 (0.40%)  2 0/481 (0.00%)  0
Pleural Effusion  1/499 (0.20%)  1 0/481 (0.00%)  0
Post-Menopausal Bleeding  0/499 (0.00%)  0 1/481 (0.21%)  1
Presyncope  1/499 (0.20%)  1 0/481 (0.00%)  0
Pruritus/Itching  3/499 (0.60%)  3 1/481 (0.21%)  1
Pulmonary Congestion  1/499 (0.20%)  1 0/481 (0.00%)  0
Right Axis Deviation  1/499 (0.20%)  1 0/481 (0.00%)  0
Right Bundle Branch Block/Complete Right Bundle Branch Block  2/499 (0.40%)  2 0/481 (0.00%)  0
ST Segment Changes  1/499 (0.20%)  1 0/481 (0.00%)  0
ST-T Wave Abnormality  3/499 (0.60%)  3 0/481 (0.00%)  0
Sick Sinus Syndrome  1/499 (0.20%)  1 0/481 (0.00%)  0
Sinus Bradycardia/Sinus Bradycardia (Cardiac Arrhythmia)  19/499 (3.81%)  20 0/481 (0.00%)  0
Sinus Tachycardia  1/499 (0.20%)  1 0/481 (0.00%)  0
Sore Throat  3/499 (0.60%)  3 0/481 (0.00%)  0
T-Wave Abnormalities  1/499 (0.20%)  1 0/481 (0.00%)  0
TEE-Related Event  10/499 (2.00%)  10 1/481 (0.21%)  1
Trigeminy  1/499 (0.20%)  1 0/481 (0.00%)  0
Unsustained/Nonsustained Ventricular Tachycardia/Cardiac Arrhythmia  4/499 (0.80%)  4 0/481 (0.00%)  0
VASC Bleeding  16/499 (3.21%)  16 0/481 (0.00%)  0
VASC Bruise  1/499 (0.20%)  1 0/481 (0.00%)  0
VASC Hematoma  36/499 (7.21%)  36 1/481 (0.21%)  1
VASC Pain  32/499 (6.41%)  32 0/481 (0.00%)  0
Vaso Vagal Response  6/499 (1.20%)  6 1/481 (0.21%)  1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Laura O'Brien
Organization: Abbott
Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT00465270     History of Changes
Other Study ID Numbers: AGA-006
G990318
First Submitted: April 23, 2007
First Posted: April 24, 2007
Results First Submitted: May 25, 2018
Results First Posted: September 3, 2018
Last Update Posted: September 3, 2018