Study: NCT00530894

Adverse event: Other
Serious: yes
Organ System: General disorders
Frequency: 91 affected / 348 at risk

Adverse event: Infection (including Endocarditis)
Serious: yes
Organ System: Infections and infestations
Frequency: 70 affected / 348 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 50 affected / 348 at risk

Adverse event: Respiratory Event
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 46 affected / 348 at risk

Adverse event: Bleeding event
Serious: yes
Organ System: Vascular disorders
Frequency: 32 affected / 348 at risk

Adverse event: Neurological event (including TIA stroke and psychomotor deficit)
Serious: yes
Organ System: Nervous system disorders
Frequency: 33 affected / 348 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 32 affected / 348 at risk

Adverse event: Gastro-Intestinal Event
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 348 at risk

Adverse event: Hemorrhagic/Vascular event
Serious: yes
Organ System: Vascular disorders
Frequency: 21 affected / 348 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 20 affected / 348 at risk

Adverse event: Abnormal Lab Values
Serious: yes
Organ System: Investigations
Frequency: 16 affected / 348 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 348 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 11 affected / 348 at risk

Adverse event: Conduction defects
Serious: yes
Organ System: Cardiac disorders
Frequency: 11 affected / 348 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 8 affected / 348 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Vascular disorders
Frequency: 7 affected / 348 at risk

Adverse event: Device embolisation
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 348 at risk

Adverse event: Syncope
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 348 at risk

Adverse event: Aortic insufficiency without paravalvular leak
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 348 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 348 at risk

Adverse event: Ischaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 348 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 348 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 348 at risk

Adverse event: Perforation or damage to myocardium
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 348 at risk

Adverse event: Embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 348 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 348 at risk

Adverse event: Device dislocation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 348 at risk

Adverse event: Electrolyte imbalance
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 348 at risk

Adverse event: Perivalvular leak
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 348 at risk

Adverse event: Valve stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 348 at risk

Adverse event: Mitral valve incompetence
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 348 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 133 affected / 348 at risk

Adverse event: Abnormal Lab Values
Serious: no
Organ System: Investigations
Frequency: 84 affected / 348 at risk

Adverse event: Infection (including Endocarditis)
Serious: no
Organ System: Infections and infestations
Frequency: 60 affected / 348 at risk

Adverse event: Arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 43 affected / 348 at risk

Adverse event: Respiratory Event
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 33 affected / 348 at risk

Adverse event: Bleeding event
Serious: no
Organ System: Vascular disorders
Frequency: 25 affected / 348 at risk

Adverse event: Hemorrhagic/Vascular event
Serious: no
Organ System: Vascular disorders
Frequency: 25 affected / 348 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 24 affected / 348 at risk

Adverse event: Gastro-Intestinal Event
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 348 at risk

Adverse event: Cardiac failure congestive
Serious: no
Organ System: Cardiac disorders
Frequency: 18 affected / 348 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 19 affected / 348 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 18 affected / 348 at risk

Adverse event: Other
Serious: yes
Organ System: General disorders
Frequency: 86 affected / 351 at risk

Adverse event: Infection (including Endocarditis)
Serious: yes
Organ System: Infections and infestations
Frequency: 59 affected / 351 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 51 affected / 351 at risk

Adverse event: Respiratory Event
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 61 affected / 351 at risk

Adverse event: Bleeding event
Serious: yes
Organ System: Vascular disorders
Frequency: 38 affected / 351 at risk

Adverse event: Neurological event (including TIA stroke and psychomotor deficit)
Serious: yes
Organ System: Nervous system disorders
Frequency: 24 affected / 351 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 38 affected / 351 at risk

Adverse event: Gastro-Intestinal Event
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 351 at risk

Adverse event: Hemorrhagic/Vascular event
Serious: yes
Organ System: Vascular disorders
Frequency: 20 affected / 351 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 26 affected / 351 at risk

Adverse event: Abnormal Lab Values
Serious: yes
Organ System: Investigations
Frequency: 15 affected / 351 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 351 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 14 affected / 351 at risk

Adverse event: Conduction defects
Serious: yes
Organ System: Cardiac disorders
Frequency: 12 affected / 351 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 8 affected / 351 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 351 at risk

Adverse event: Syncope
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 351 at risk

Adverse event: Ischaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 351 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 351 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 351 at risk

Adverse event: Perforation or damage to myocardium
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 351 at risk

Adverse event: Embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 351 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 351 at risk

Adverse event: Valve stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 351 at risk

Adverse event: Haemolysis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 351 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 351 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 124 affected / 351 at risk

Adverse event: Abnormal Lab Values
Serious: no
Organ System: Investigations
Frequency: 84 affected / 351 at risk

Adverse event: Infection (including Endocarditis)
Serious: no
Organ System: Infections and infestations
Frequency: 58 affected / 351 at risk

Adverse event: Arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 78 affected / 351 at risk

Adverse event: Respiratory Event
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 32 affected / 351 at risk

Adverse event: Bleeding event
Serious: no
Organ System: Vascular disorders
Frequency: 22 affected / 351 at risk

Adverse event: Hemorrhagic/Vascular event
Serious: no
Organ System: Vascular disorders
Frequency: 7 affected / 351 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 47 affected / 351 at risk

Adverse event: Gastro-Intestinal Event
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 351 at risk

Adverse event: Cardiac failure congestive
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 351 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 16 affected / 351 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 351 at risk

Adverse event: Other
Serious: yes
Organ System: General disorders
Frequency: 60 affected / 179 at risk

Adverse event: Infection (including Endocarditis)
Serious: yes
Organ System: Infections and infestations
Frequency: 35 affected / 179 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 24 affected / 179 at risk

Adverse event: Respiratory Event
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 25 affected / 179 at risk

Adverse event: Bleeding event
Serious: yes
Organ System: Vascular disorders
Frequency: 23 affected / 179 at risk

Adverse event: Neurological event (including TIA stroke and psychomotor deficit)
Serious: yes
Organ System: Nervous system disorders
Frequency: 24 affected / 179 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 22 affected / 179 at risk

Adverse event: Gastro-Intestinal Event
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 179 at risk

Adverse event: Hemorrhagic/Vascular event
Serious: yes
Organ System: Vascular disorders
Frequency: 23 affected / 179 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 11 affected / 179 at risk

Adverse event: Abnormal Lab Values
Serious: yes
Organ System: Investigations
Frequency: 12 affected / 179 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 179 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 9 affected / 179 at risk

Adverse event: Conduction defects
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 179 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 179 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 179 at risk

Adverse event: Syncope
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 179 at risk

Adverse event: Aortic insufficiency without paravalvular leak
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 179 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 179 at risk

Adverse event: Ischaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 179 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 179 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 179 at risk

Adverse event: Perforation or damage to myocardium
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 179 at risk

Adverse event: Embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 179 at risk

Adverse event: Perivalvular leak
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 179 at risk

Adverse event: Valve stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 179 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 179 at risk

Adverse event: Access site nerve injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 179 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 87 affected / 179 at risk

Adverse event: Abnormal Lab Values
Serious: no
Organ System: Investigations
Frequency: 51 affected / 179 at risk

Adverse event: Infection (including Endocarditis)
Serious: no
Organ System: Infections and infestations
Frequency: 44 affected / 179 at risk

Adverse event: Arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 26 affected / 179 at risk

Adverse event: Respiratory Event
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 179 at risk

Adverse event: Bleeding event
Serious: no
Organ System: Vascular disorders
Frequency: 16 affected / 179 at risk

Adverse event: Hemorrhagic/Vascular event
Serious: no
Organ System: Vascular disorders
Frequency: 20 affected / 179 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 179 at risk

Adverse event: Gastro-Intestinal Event
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 179 at risk

Adverse event: Cardiac failure congestive
Serious: no
Organ System: Cardiac disorders
Frequency: 8 affected / 179 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 19 affected / 179 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 24 affected / 179 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 12 affected / 179 at risk

Adverse event: Valve stenosis
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 179 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 10 affected / 179 at risk

Adverse event: Neurological event (including TIA stroke and psychomotor deficit)
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 179 at risk

Adverse event: Other
Serious: yes
Organ System: General disorders
Frequency: 68 affected / 179 at risk

Adverse event: Infection (including Endocarditis)
Serious: yes
Organ System: Infections and infestations
Frequency: 30 affected / 179 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 78 affected / 179 at risk

Adverse event: Respiratory Event
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 21 affected / 179 at risk

Adverse event: Bleeding event
Serious: yes
Organ System: Vascular disorders
Frequency: 13 affected / 179 at risk

Adverse event: Neurological event (including TIA stroke and psychomotor deficit)
Serious: yes
Organ System: Nervous system disorders
Frequency: 7 affected / 179 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 24 affected / 179 at risk

Adverse event: Gastro-Intestinal Event
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 179 at risk

Adverse event: Hemorrhagic/Vascular event
Serious: yes
Organ System: Vascular disorders
Frequency: 9 affected / 179 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 12 affected / 179 at risk

Adverse event: Abnormal Lab Values
Serious: yes
Organ System: Investigations
Frequency: 11 affected / 179 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 179 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 179 at risk

Adverse event: Conduction defects
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 179 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 179 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 179 at risk

Adverse event: Syncope
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 179 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 179 at risk

Adverse event: Ischaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 179 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Vascular disorders
Frequency: 6 affected / 179 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 179 at risk

Adverse event: Valve stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 33 affected / 179 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 44 affected / 179 at risk

Adverse event: Abnormal Lab Values
Serious: no
Organ System: Investigations
Frequency: 28 affected / 179 at risk

Adverse event: Infection (including Endocarditis)
Serious: no
Organ System: Infections and infestations
Frequency: 34 affected / 179 at risk

Adverse event: Arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 16 affected / 179 at risk

Adverse event: Respiratory Event
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 179 at risk

Adverse event: Bleeding event
Serious: no
Organ System: Vascular disorders
Frequency: 7 affected / 179 at risk

Adverse event: Hemorrhagic/Vascular event
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 179 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 179 at risk

Adverse event: Gastro-Intestinal Event
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 179 at risk

Adverse event: Cardiac failure congestive
Serious: no
Organ System: Cardiac disorders
Frequency: 15 affected / 179 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 8 affected / 179 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 8 affected / 179 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 179 at risk

Adverse event: Valve stenosis
Serious: no
Organ System: Cardiac disorders
Frequency: 11 affected / 179 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 179 at risk

Adverse event: Neurological event (including TIA stroke and psychomotor deficit)
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 179 at risk