Study: NCT02338154

Adverse event: Anaphylactic reaction
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 516 at risk

Adverse event: Anemia - Bleeding related - Major
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 516 at risk

Adverse event: Anemia - Bleeding related - Minor
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 516 at risk

Adverse event: Anemia - Non-bleeding related
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 516 at risk

Adverse event: Angina, Stable
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 516 at risk

Adverse event: Angina, Unstable
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 516 at risk

Adverse event: Arrhythmia - AV Block - 1st degree
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 516 at risk

Adverse event: Arrhythmia - AV Block - 2nd degree
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 516 at risk

Adverse event: Arrhythmia - AV Block - 3rd degree
Serious: yes
Organ System: Cardiac disorders
Frequency: 25 affected / 516 at risk

Adverse event: Arrhythmia - Atrial Flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 516 at risk

Adverse event: Arrhythmia - Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 516 at risk

Adverse event: Arrhythmia - Bundle Branch Block - Left
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 516 at risk

Adverse event: Arrhythmia - Other
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 516 at risk

Adverse event: Arrhythmia - Paroxysmal Atrial Fibrillation (PAF)
Serious: yes
Organ System: Cardiac disorders
Frequency: 34 affected / 516 at risk

Adverse event: Arrhythmia - Permanent Atrial Fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 516 at risk

Adverse event: Arrhythmia - Persistant Atrial Fibrillaiton
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 516 at risk

Adverse event: Arrhythmia - Tachycardia - Ventricular
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 516 at risk

Adverse event: Arrhythmia - Ventricular Fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 516 at risk

Adverse event: Atelectasis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 516 at risk

Adverse event: Biliary (Gallbladder)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 516 at risk

Adverse event: Bleeding - Cardiovascular - Major
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 16 affected / 516 at risk

Adverse event: Bleeding - Cardiovascular - Minor
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 516 at risk

Adverse event: Bleeding - Gastrointestinal upper -Major
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 516 at risk

Adverse event: Bleeding - Gastrointestinal upper -Minor
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 516 at risk

Adverse event: Bleeding - Neurological - Major (e.g. CVA)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 516 at risk

Adverse event: Bleeding - Pulmonary/Respiratory - Major (e.g. hemothorax)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 516 at risk

Adverse event: Blood Sepsis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 516 at risk

Adverse event: Blood/ Lymphatic - Other
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 516 at risk

Adverse event: Bone Fracture/Break
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 516 at risk

Adverse event: Cancer - Newly diagnosed
Serious: yes
Organ System: General disorders
Frequency: 9 affected / 516 at risk

Adverse event: Cancer - Progression of underlying disease
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 516 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 516 at risk

Adverse event: Cardiac Decompensation
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 516 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 516 at risk

Adverse event: Cardiovascular - Other
Serious: yes
Organ System: Cardiac disorders
Frequency: 14 affected / 516 at risk

Adverse event: Endocarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 516 at risk

Adverse event: Gastrointestinal - Infection
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 516 at risk

Adverse event: Gastrointestinal - Other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 516 at risk

Adverse event: Genitourinary - Other
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 7 affected / 516 at risk

Adverse event: Heart Failure - Acute
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 516 at risk

Adverse event: Heart Failure - Chronic (CHF)
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 516 at risk

Adverse event: Hepatic complication - Other
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 516 at risk

Adverse event: Hypertension - Systemic
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 516 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 516 at risk

Adverse event: Infection /Inflammation - Other
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 516 at risk

Adverse event: Liver Failure - Acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 516 at risk

Adverse event: Multi-System organ failure
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 516 at risk

Adverse event: Muscular Skeletal / Dermatologic - Other
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 17 affected / 516 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 516 at risk

Adverse event: NSD - Paravalvular Leak - +2
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 516 at risk

Adverse event: NSD - Paravalvular Leak - +3
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 516 at risk

Adverse event: NSD - Paravalvular Leak - +4
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 516 at risk

Adverse event: Nonspecific, Unknown, or Other Body System - Other complication
Serious: yes
Organ System: General disorders
Frequency: 17 affected / 516 at risk

Adverse event: Pancreatic complication
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 516 at risk

Adverse event: Perforation - Atrial
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 516 at risk

Adverse event: Perforation - Other
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 516 at risk

Adverse event: Pericardial Effusion - Major
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 516 at risk

Adverse event: Pericardial Effusion - Minor
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 516 at risk

Adverse event: Pericardial Tamponade - Major
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 516 at risk

Adverse event: Pleural Effusion - Bilateral
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 516 at risk

Adverse event: Pleural Effusion - Left
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 516 at risk

Adverse event: Pleural Effusion - Right
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 516 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 516 at risk

Adverse event: Psychiatric - Other
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 516 at risk

Adverse event: Psychiatric Disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 516 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 516 at risk

Adverse event: Pulmonary Embolism - Bilateral
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 516 at risk

Adverse event: Pulmonary Embolism - Right
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 516 at risk

Adverse event: Pulmonary/Respiratory - Other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 516 at risk

Adverse event: Regurgitation - Aortic-Central/Transvalvular-+3
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 516 at risk

Adverse event: Regurgitation - Aortic-Central/Transvalvular-+4
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 516 at risk

Adverse event: Regurgitation - Aortic-Indeterminate-+2
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 516 at risk

Adverse event: Regurgitation - Aortic-Indeterminate-+4
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 516 at risk

Adverse event: Renal Dysfunction
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 9 affected / 516 at risk

Adverse event: Renal Failure - Acute
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 12 affected / 516 at risk

Adverse event: Renal Failure - Chronic
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 516 at risk

Adverse event: Respiratory Dysfunction/Insufficiency
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 516 at risk

Adverse event: Respiratory Failure -COPD
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 516 at risk

Adverse event: Respiratory Failure -Other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 516 at risk

Adverse event: Respiratory Failure -Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 516 at risk

Adverse event: Respiratory Failure -Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 516 at risk

Adverse event: Respiratory Infection - Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 516 at risk

Adverse event: Respiratory Infection - Upper (URI)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 516 at risk

Adverse event: SVD - Stent frame separation
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 516 at risk

Adverse event: Speech disorder
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 516 at risk

Adverse event: Sternal Wound/Thoracic Infection
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 516 at risk

Adverse event: Completed suicide
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 516 at risk

Adverse event: Thromboembolic Event - Other - Central - Hemiparesis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 516 at risk

Adverse event: Thromboembolic Event - Other - Peripheral - No paresis
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 516 at risk

Adverse event: Thromboembolic Event - Stroke
Serious: yes
Organ System: Cardiac disorders
Frequency: 10 affected / 516 at risk

Adverse event: Thromboembolic Event - Transient Ischemic Attack (TIA)
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 516 at risk

Adverse event: Urinary Tract Infection (UTI)
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 516 at risk

Adverse event: Valve Thrombosis - Aortic
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 516 at risk

Adverse event: Vascular - Other
Serious: yes
Organ System: Vascular disorders
Frequency: 8 affected / 516 at risk

Adverse event: NSD - Paravalvular leak with Hemolysis
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 516 at risk

Adverse event: Respiratory Failure -Acute Respiratory Distress Syndrome (ARDS)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 516 at risk

Adverse event: Allergic Reaction - Medication related
Serious: no
Organ System: General disorders
Frequency: 1 affected / 516 at risk

Adverse event: Anemia - Bleeding related - Major
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 516 at risk

Adverse event: Anemia - Bleeding related - Minor
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 516 at risk

Adverse event: Anemia - Non-bleeding related
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 516 at risk

Adverse event: Angina, Stable
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 516 at risk

Adverse event: Arrhythmia - AV Block - 1st degree
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 516 at risk

Adverse event: Arrhythmia - AV Block - 3rd degree
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 516 at risk

Adverse event: Arrhythmia - Bundle Branch Block - Left
Serious: no
Organ System: Cardiac disorders
Frequency: 12 affected / 516 at risk

Adverse event: Arrhythmia - Bundle Branch Block - Right
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 516 at risk

Adverse event: Arrhythmia - Paroxysmal Atrial Fibrillation (PAF)
Serious: no
Organ System: Cardiac disorders
Frequency: 46 affected / 516 at risk

Adverse event: Arrhythmia - Permanent Atrial Fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 516 at risk

Adverse event: Arrhythmia - Persistant Atrial Fibrillaiton
Serious: no
Organ System: Cardiac disorders
Frequency: 15 affected / 516 at risk

Adverse event: Arrhythmia - Tachycardia - Ventricular
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 516 at risk

Adverse event: Biliary (Gallbladder)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 516 at risk

Adverse event: Bleeding - Cardiovascular - Minor
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 516 at risk

Adverse event: Bleeding - Gastrointestinal lower -Minor
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 516 at risk

Adverse event: Bleeding - Gastrointestinal upper -Minor
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 516 at risk

Adverse event: Bleeding - Genitourinary - Minor
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 516 at risk

Adverse event: Bleeding - Peripheral vascular - Minor (e.g. nosebleeds; hematomas)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 516 at risk

Adverse event: Blood/ Lymphatic - Other
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 516 at risk

Adverse event: Bone Fracture/Break
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 516 at risk

Adverse event: Cancer - Newly diagnosed
Serious: no
Organ System: General disorders
Frequency: 2 affected / 516 at risk

Adverse event: Cardiovascular - Other
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 516 at risk

Adverse event: Endocrine complications
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 516 at risk

Adverse event: Gastrointestinal - Other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 516 at risk

Adverse event: Heart Failure - Chronic (CHF)
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 516 at risk

Adverse event: Hepatic complication - Other
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 516 at risk

Adverse event: Hypertension - Systemic
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 516 at risk

Adverse event: Infection /Inflammation - Other
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 516 at risk

Adverse event: Muscular Skeletal / Dermatologic - Other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 14 affected / 516 at risk

Adverse event: NSD - Paravalvular Leak - +2
Serious: no
Organ System: General disorders
Frequency: 2 affected / 516 at risk

Adverse event: NSD - Paravalvular leak with Hemolysis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 516 at risk

Adverse event: Nonspecific, Unknown, or Other Body System - Other complication
Serious: no
Organ System: General disorders
Frequency: 3 affected / 516 at risk

Adverse event: Pericardial Effusion - Minor
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 516 at risk

Adverse event: Pleural Effusion - Bilateral
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 516 at risk

Adverse event: Pleural Effusion - Left
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 516 at risk

Adverse event: Pneumothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 516 at risk

Adverse event: Psychiatric - Other
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 516 at risk

Adverse event: Psychiatric Disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 516 at risk

Adverse event: Pulmonary/Respiratory - Other
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 516 at risk

Adverse event: Renal Dysfunction
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 516 at risk

Adverse event: Renal Failure - Acute
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 516 at risk

Adverse event: Respiratory Dysfunction/Insufficiency
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 516 at risk

Adverse event: Respiratory Failure -COPD
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 516 at risk

Adverse event: Respiratory Infection - Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 516 at risk

Adverse event: Respiratory Infection - Upper (URI)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 516 at risk

Adverse event: Sternal Wound/Thoracic Infection
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 516 at risk

Adverse event: Thrombocytopenia - Non-Heparin Induced
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 516 at risk

Adverse event: Thromboembolic Event - Other - Peripheral - Hemiparesis
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 516 at risk

Adverse event: Thromboembolic Event - Stroke
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 516 at risk

Adverse event: Thromboembolic Event - Transient Ischemic Attack (TIA)
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 516 at risk

Adverse event: Transient Psychotic Syndrome
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 516 at risk

Adverse event: Urinary Tract Infection (UTI)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 15 affected / 516 at risk

Adverse event: Vascular - Deep Vein Thrombosis (DVT)
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 516 at risk

Adverse event: Vascular - Other
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 516 at risk

Adverse event: Vision disorder
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 516 at risk

Adverse event: Wound Infection - Other
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 516 at risk