Study: NCT02184442

Adverse event: Abnormal lab value
Serious: yes
Organ System: Investigations
Frequency: 11 affected / 280 at risk

Adverse event: Access site infection
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 280 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 280 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 12 affected / 280 at risk

Adverse event: Aortic root rupture
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 280 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 33 affected / 280 at risk

Adverse event: Aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 280 at risk

Adverse event: Bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 280 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 5 affected / 280 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 10 affected / 280 at risk

Adverse event: Cardiac Tamponade/Pericardial Effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 280 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 280 at risk

Adverse event: Change in level of consciousness
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 280 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 280 at risk

Adverse event: Coronary Flow Obstruction/Transvalvular flow disturbance
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 280 at risk

Adverse event: Dementia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 280 at risk

Adverse event: Device embolisation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 280 at risk

Adverse event: Device dislocation
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 280 at risk

Adverse event: Dissection
Serious: yes
Organ System: Vascular disorders
Frequency: 10 affected / 280 at risk

Adverse event: Distal embolization from vascular source
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 280 at risk

Adverse event: Aphasia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 280 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 280 at risk

Adverse event: Oedema
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 280 at risk

Adverse event: Embolization including air/calcific valve material or Thrombus
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 280 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 280 at risk

Adverse event: Endocarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 280 at risk

Adverse event: Exercise intolerance or weakness
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 280 at risk

Adverse event: Failure of percutaneous access site closure resulting in intervention
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 280 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 280 at risk

Adverse event: Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 280 at risk

Adverse event: Gastro Intestinal Event
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 280 at risk

Adverse event: Gastro Intestinal Event Nonhemorrhagic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 280 at risk

Adverse event: Genito Urinary Event
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 280 at risk

Adverse event: Heart Failure / CHF / Low output Failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 46 affected / 280 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 280 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 37 affected / 280 at risk

Adverse event: Haemorrhagic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 280 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 280 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 280 at risk

Adverse event: Ischaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 280 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 11 affected / 280 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 280 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Vascular disorders
Frequency: 6 affected / 280 at risk

Adverse event: Non Structural Dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 280 at risk

Adverse event: Other
Serious: yes
Organ System: General disorders
Frequency: 45 affected / 280 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 280 at risk

Adverse event: Perforation
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 280 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 280 at risk

Adverse event: Vascular pseudoaneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 280 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 280 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 280 at risk

Adverse event: Renal Insufficiency or Renal Failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 16 affected / 280 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 280 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 22 affected / 280 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 14 affected / 280 at risk

Adverse event: Stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 280 at risk

Adverse event: Structural Dysfunction
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 280 at risk

Adverse event: Syncope
Serious: yes
Organ System: Vascular disorders
Frequency: 7 affected / 280 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 280 at risk

Adverse event: Thoracic aortic dissection
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 280 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 280 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 8 affected / 280 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 12 affected / 280 at risk

Adverse event: Ventricular rupture (Apical rupture)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 280 at risk

Adverse event: Abnormal Lab Value
Serious: no
Organ System: Investigations
Frequency: 49 affected / 280 at risk

Adverse event: Anemia/Hemolytic Anemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 35 affected / 280 at risk

Adverse event: Arrhythmia/Conduction System Injury (Defect)
Serious: no
Organ System: Cardiac disorders
Frequency: 46 affected / 280 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 8 affected / 280 at risk

Adverse event: Oedema
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 11 affected / 280 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 12 affected / 280 at risk

Adverse event: Gastro Intestinal Event
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 280 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Vascular disorders
Frequency: 28 affected / 280 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 12 affected / 280 at risk

Adverse event: Non Structural Dysfunction
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 13 affected / 280 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 25 affected / 280 at risk

Adverse event: Renal Insufficiency or Renal Failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 22 affected / 280 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 280 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 16 affected / 280 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 28 affected / 280 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 79 affected / 280 at risk

Adverse event: Abnormal lab value
Serious: yes
Organ System: Investigations
Frequency: 7 affected / 263 at risk

Adverse event: Access site infection
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 263 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 263 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 30 affected / 263 at risk

Adverse event: Aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 263 at risk

Adverse event: Bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 263 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 263 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 17 affected / 263 at risk

Adverse event: Cardiac Tamponade/Pericardial Effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 263 at risk

Adverse event: Change in level of consciousness
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 263 at risk

Adverse event: Cognitive disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 263 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 5 affected / 263 at risk

Adverse event: Coronary Flow Obstruction/Transvalvular flow disturbance
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 263 at risk

Adverse event: Delirium
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 263 at risk

Adverse event: Device embolisation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 263 at risk

Adverse event: Device dislocation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 263 at risk

Adverse event: Dissection
Serious: yes
Organ System: Vascular disorders
Frequency: 14 affected / 263 at risk

Adverse event: Distal embolization from vascular source
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 263 at risk

Adverse event: Aphasia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 263 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 263 at risk

Adverse event: Oedema
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 263 at risk

Adverse event: Embolization including air/calcific valve material or Thrombus
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 263 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 263 at risk

Adverse event: Endocarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 263 at risk

Adverse event: Exercise intolerance or weakness
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 263 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 10 affected / 263 at risk

Adverse event: Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 263 at risk

Adverse event: Gastro Intestinal Event
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 263 at risk

Adverse event: Gastro Intestinal Event Nonhemorrhagic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 263 at risk

Adverse event: Genito Urinary Event Nonhemorrhagic
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 263 at risk

Adverse event: Heart Failure / CHF / Low output Failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 39 affected / 263 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 263 at risk

Adverse event: Hemiparesis (One sided body weakness)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 263 at risk

Adverse event: Hemiplegia (One side limb weakness)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 263 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 30 affected / 263 at risk

Adverse event: Haemorrhagic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 263 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 263 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 7 affected / 263 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 8 affected / 263 at risk

Adverse event: Mitral Valve Injury or Insufficiency
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 263 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 263 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 263 at risk

Adverse event: Non Structural Dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 263 at risk

Adverse event: Other
Serious: yes
Organ System: General disorders
Frequency: 42 affected / 263 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 263 at risk

Adverse event: Perforation
Serious: yes
Organ System: Vascular disorders
Frequency: 9 affected / 263 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 263 at risk

Adverse event: Vascular pseudoaneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 8 affected / 263 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 263 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 263 at risk

Adverse event: Renal Insufficiency or Renal Failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 13 affected / 263 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 263 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 17 affected / 263 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 10 affected / 263 at risk

Adverse event: Stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 263 at risk

Adverse event: Syncope
Serious: yes
Organ System: Vascular disorders
Frequency: 8 affected / 263 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 263 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 263 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 263 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 263 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 10 affected / 263 at risk

Adverse event: Hemiplegia (One side limb weakness)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 263 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 263 at risk

Adverse event: Abnormal Lab Value
Serious: no
Organ System: Investigations
Frequency: 52 affected / 263 at risk

Adverse event: Anemia/Hemolytic Anemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 36 affected / 263 at risk

Adverse event: Arrhythmia/Conduction System Injury (Defect)
Serious: no
Organ System: Cardiac disorders
Frequency: 41 affected / 263 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 16 affected / 263 at risk

Adverse event: Oedema
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 18 affected / 263 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 19 affected / 263 at risk

Adverse event: Gastro Intestinal Event
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 263 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Vascular disorders
Frequency: 30 affected / 263 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 17 affected / 263 at risk

Adverse event: Non Structural Dysfunction
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 15 affected / 263 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 18 affected / 263 at risk

Adverse event: Renal Insufficiency or Renal Failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 14 affected / 263 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 263 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 18 affected / 263 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 35 affected / 263 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 87 affected / 263 at risk