Study: NCT01445171

Adverse event: Other
Serious: yes
Organ System: General disorders
Frequency: 137 affected / 287 at risk

Adverse event: Pulmonary - Pleural Effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 57 affected / 287 at risk

Adverse event: Infection - Other
Serious: yes
Organ System: Infections and infestations
Frequency: 37 affected / 287 at risk

Adverse event: Cardiac - Other
Serious: yes
Organ System: Cardiac disorders
Frequency: 32 affected / 287 at risk

Adverse event: Gastrointestinal - Other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 287 at risk

Adverse event: Cardiac - Atrial Fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 32 affected / 287 at risk

Adverse event: Other - Anemia
Serious: yes
Organ System: General disorders
Frequency: 25 affected / 287 at risk

Adverse event: Cardiac - Heart Failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 20 affected / 287 at risk

Adverse event: Cardiac - Other Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 18 affected / 287 at risk

Adverse event: Cardiac - AV Block III
Serious: yes
Organ System: Cardiac disorders
Frequency: 17 affected / 287 at risk

Adverse event: Embolic Event - Stroke
Serious: yes
Organ System: Cardiac disorders
Frequency: 16 affected / 287 at risk

Adverse event: Infection - Local
Serious: yes
Organ System: Infections and infestations
Frequency: 16 affected / 287 at risk

Adverse event: Infection - Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 16 affected / 287 at risk

Adverse event: Renal - Renal Failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 13 affected / 287 at risk

Adverse event: Vascular - Other
Serious: yes
Organ System: Vascular disorders
Frequency: 12 affected / 287 at risk

Adverse event: Bleeding - Gastrointestinal
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 287 at risk

Adverse event: Pulmonary - Other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 287 at risk

Adverse event: Bleeding - Post-Procedural
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 287 at risk

Adverse event: Bleeding - Other
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 287 at risk

Adverse event: Cardiac - Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 11 affected / 287 at risk

Adverse event: Pulmonary - Respiratory Dysfunction/Insufficiency
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 287 at risk

Adverse event: Renal - Renal Dysfunction
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 9 affected / 287 at risk

Adverse event: Cardiac - Atrial Flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 287 at risk

Adverse event: Cardiac - Pericardial Effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 287 at risk

Adverse event: Embolic Event - TIA
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 287 at risk

Adverse event: Infection - Sternal Wound Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 287 at risk

Adverse event: Cardiac - Cardiac Arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 287 at risk

Adverse event: Cardiac - Myocardial Infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 287 at risk

Adverse event: Infection - Sepsis/Septicemia
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 287 at risk

Adverse event: Cardiac - Angina, Stable
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 287 at risk

Adverse event: Pulmonary - Respiratory Failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 287 at risk

Adverse event: Infection - Bacteremia
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 287 at risk

Adverse event: Pulmonary - Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 287 at risk

Adverse event: Renal - Other
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 5 affected / 287 at risk

Adverse event: Cardiac - Angina, Unstable
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 287 at risk

Adverse event: Bleeding - Anticoagulant Related
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 287 at risk

Adverse event: Bleeding - Hematoma
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 287 at risk

Adverse event: Bleeding - Pericardial Tamponade
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 287 at risk

Adverse event: Cardiac - Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 287 at risk

Adverse event: Other - Allergic Reaction
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 287 at risk

Adverse event: Vascular - Deep Vein Thrombosis (DVT)
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 287 at risk

Adverse event: Infection - Endocarditis (Aortic Valve)
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 287 at risk

Adverse event: Bleeding - Hemolysis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 287 at risk

Adverse event: Bleeding - Procedural
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 287 at risk

Adverse event: Cardiac - Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 287 at risk

Adverse event: Cardiac - Supraventricular Tachycardia (SVT)
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 287 at risk

Adverse event: Embolic Event - Other
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 287 at risk

Adverse event: Embolic Event - Pulmonary Embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 287 at risk

Adverse event: Hepatic - Other
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 287 at risk

Adverse event: Multisystem Organ Failure
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 287 at risk

Adverse event: Valvular - Paravalvular Leak - Moderate
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 287 at risk

Adverse event: Bleeding - Intracranial
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 287 at risk

Adverse event: Cardiac - Aortic Dissection - Type A
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 287 at risk

Adverse event: Cardiac - Aortic Dissection - Type B
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 287 at risk

Adverse event: Cardiac - AV Block II
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 287 at risk

Adverse event: Cardiac - Cardiogenic Shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 287 at risk

Adverse event: Cardiac - Pericardial Tamponade
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 287 at risk

Adverse event: Cardiac - Ventricular Fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 287 at risk

Adverse event: Embolic Event - Peripheral Embolic Event
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 287 at risk

Adverse event: Hepatic - Liver Failure
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 287 at risk

Adverse event: Infection - Endocarditis (Mitral Valve)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 287 at risk

Adverse event: Infection - Systemic
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 287 at risk

Adverse event: Pulmonary - Atelectasis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 287 at risk

Adverse event: Pulmonary - Pulmonary Edema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 287 at risk

Adverse event: Pulmonary - Pulmonary Hypertension
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 287 at risk

Adverse event: Valvular - Aortic Regurgitation - Moderate-Severe
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 287 at risk

Adverse event: Valvular - Mitral Regurgitation - Mild-Moderate
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 287 at risk

Adverse event: Valvular - Mitral Regurgitation - Moderate-Severe
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 287 at risk

Adverse event: Valvular - Other Mitral Valve
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 287 at risk

Adverse event: Valvular - Paravalvular Leak - Mild
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 287 at risk

Adverse event: Vascular - Vascular Access Site Complication
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 287 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 85 affected / 287 at risk

Adverse event: Infection - Other
Serious: no
Organ System: Infections and infestations
Frequency: 45 affected / 287 at risk

Adverse event: Cardiac - Atrial Fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 43 affected / 287 at risk

Adverse event: Gastrointestinal - Other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 287 at risk

Adverse event: Pulmonary - Pleural Effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 16 affected / 287 at risk

Adverse event: Infection - Local
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 287 at risk

Adverse event: Other - Anemia
Serious: no
Organ System: General disorders
Frequency: 11 affected / 287 at risk

Adverse event: Cardiac - BBB - Left Complete
Serious: no
Organ System: Cardiac disorders
Frequency: 9 affected / 287 at risk

Adverse event: Renal - Renal Dysfunction
Serious: no
Organ System: Renal and urinary disorders
Frequency: 9 affected / 287 at risk

Adverse event: Valvular - Mitral Regurgitation - Mild
Serious: no
Organ System: Cardiac disorders
Frequency: 9 affected / 287 at risk

Adverse event: Cardiac - Other
Serious: no
Organ System: Cardiac disorders
Frequency: 8 affected / 287 at risk

Adverse event: Cardiac - BBB - Left Partial
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 287 at risk

Adverse event: Cardiac - Other Arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 287 at risk

Adverse event: Infection - Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 287 at risk

Adverse event: Pulmonary - Other
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 287 at risk

Adverse event: Cardiac - Atrial Flutter
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 287 at risk

Adverse event: Infection - Sternal Wound Infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 287 at risk

Adverse event: Renal - Other
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 287 at risk

Adverse event: Valvular - Aortic Regurgitation - Mild
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 287 at risk

Adverse event: Bleeding - Hematoma
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 287 at risk

Adverse event: Bleeding - Other
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 287 at risk

Adverse event: Cardiac - BBB - Right Complete
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 287 at risk

Adverse event: Infection - Bacteremia
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 287 at risk

Adverse event: Vascular - Deep Vein Thrombosis (DVT)
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 287 at risk

Adverse event: Other - Allergic Reaction
Serious: no
Organ System: General disorders
Frequency: 3 affected / 287 at risk

Adverse event: Bleeding - Anticoagulant Related
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 287 at risk

Adverse event: Cardiac - AV Block I
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 287 at risk

Adverse event: Cardiac - Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 287 at risk

Adverse event: Cardiac - Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 287 at risk

Adverse event: Cardiac - Ventricular Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 287 at risk

Adverse event: Hepatic - Other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 287 at risk

Adverse event: Valvular - Aortic Stenosis - Moderate
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 287 at risk

Adverse event: Bleeding - Gastrointestinal
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 287 at risk

Adverse event: Cardiac - AV Block III
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 287 at risk

Adverse event: Cardiac - Pericardial Effusion
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 287 at risk

Adverse event: Embolic Event - Other
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 287 at risk

Adverse event: Embolic Event - Stroke
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 287 at risk

Adverse event: Embolic Event - TIA
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 287 at risk

Adverse event: Bleeding - Hemolysis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 287 at risk

Adverse event: Bleeding - Heparin Induced Thrombocytopenia (HITS)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 287 at risk

Adverse event: Cardiac - Angina, Stable
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 287 at risk

Adverse event: Cardiac - Heart Failure
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 287 at risk

Adverse event: Cardiac - Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 287 at risk

Adverse event: Cardiac - Supraventricular Tachycardia (SVT)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 287 at risk

Adverse event: Embolic Event - Peripheral Embolic Event
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 287 at risk

Adverse event: Infection - Systemic
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 287 at risk

Adverse event: Pulmonary - Pneumothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 287 at risk

Adverse event: Pulmonary - Pulmonary Hypertension
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 287 at risk

Adverse event: Pulmonary - Respiratory Dysfunction/Insufficiency
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 287 at risk

Adverse event: Pulmonary - Respiratory Failure
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 287 at risk

Adverse event: Valvular - Aortic Regurgitation - Mild-Moderate
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 287 at risk

Adverse event: Valvular - Aortic Stenosis - Mild
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 287 at risk

Adverse event: Valvular - Aortic Stenosis - Severe
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 287 at risk

Adverse event: Valvular - Mitral Regurgitation - Moderate-Severe
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 287 at risk

Adverse event: Valvular - Other Mitral Valve
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 287 at risk

Adverse event: Valvular - Other Tricuspid Valve
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 287 at risk

Adverse event: Valvular - Paravalvular Leak - Mild/Moderate
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 287 at risk

Adverse event: Valvular - Paravalvular Leak - Moderate
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 287 at risk

Adverse event: Valvular - Paravalvular Leak - Trace/Trivial
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 287 at risk

Adverse event: Valvular - Structural Deterioration
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 287 at risk

Adverse event: Valvular - Tricuspid Regurgitation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 287 at risk

Adverse event: Vascular - Other
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 287 at risk