Study: NCT03225001

Adverse event: Abnormal Lab Value
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 195 at risk

Adverse event: Anemia/Hemolytic Anemia
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 195 at risk

Adverse event: Angina/Cardiac Chest Pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 195 at risk

Adverse event: Arrhythmia/Conduction System Injury (Defect)
Serious: yes
Organ System: Cardiac disorders
Frequency: 11 affected / 195 at risk

Adverse event: Bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 195 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 195 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 195 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 195 at risk

Adverse event: Change in level of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 195 at risk

Adverse event: Compartment syndrome
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 195 at risk

Adverse event: Coronary Flow Obstruction/Transvalvular flow disturbance
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 195 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 195 at risk

Adverse event: Embolization including air/calcific valve material or Thrombus
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 195 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 195 at risk

Adverse event: Endocarditis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 195 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 / 195 at risk

Adverse event: Fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 195 at risk

Adverse event: Gastro Intestinal Event
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 195 at risk

Adverse event: Gastro Intestinal Event Nonhemorrhagic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 195 at risk

Adverse event: Genito Urinary Event
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 195 at risk

Adverse event: Genito Urinary Event Nonhemorrhagic
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 195 at risk

Adverse event: Heart Failure / CHF / Low output Failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 26 affected / 195 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 22 affected / 195 at risk

Adverse event: Haemorrhagic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 195 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 195 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 195 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 195 at risk

Adverse event: Mitral Valve Injury or Insufficiency
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 195 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 195 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 195 at risk

Adverse event: Non Structural Dysfunction
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 195 at risk

Adverse event: Pain
Serious: yes
Organ System: Nervous system disorders
Frequency: 7 affected / 195 at risk

Adverse event: Perforation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 195 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 195 at risk

Adverse event: Vascular pseudoaneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 195 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 195 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 195 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 9 affected / 195 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 18 affected / 195 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 195 at risk

Adverse event: Restenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 195 at risk

Adverse event: Rupture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 195 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 195 at risk

Adverse event: Syncope
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 195 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 195 at risk

Adverse event: Death
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 195 at risk

Adverse event: Other
Serious: yes
Organ System: Investigations
Frequency: 15 affected / 195 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 195 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 195 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 195 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 195 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 195 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 195 at risk

Adverse event: Access site infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 195 at risk

Adverse event: Cough
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 195 at risk

Adverse event: Dementia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 195 at risk

Adverse event: Device Migration/malposition requiring intervention
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 195 at risk

Adverse event: Drug Reaction
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 195 at risk

Adverse event: Abnormal Lab Value
Serious: no
Organ System: Investigations
Frequency: 23 affected / 195 at risk

Adverse event: Anemia/Hemolytic Anemia
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 23 affected / 195 at risk

Adverse event: Arrhythmia/Conduction System Injury (Defect)
Serious: no
Organ System: Cardiac disorders
Frequency: 38 affected / 195 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 12 affected / 195 at risk

Adverse event: Heart Failure / CHF / Low output Failure
Serious: no
Organ System: Cardiac disorders
Frequency: 12 affected / 195 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Vascular disorders
Frequency: 40 affected / 195 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 10 affected / 195 at risk

Adverse event: Pain
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 195 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 195 at risk

Adverse event: Renal Insufficiency or Renal Failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 16 affected / 195 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 16 affected / 195 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 23 affected / 195 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 195 at risk

Adverse event: Other
Serious: no
Organ System: Investigations
Frequency: 50 affected / 195 at risk