Study: NCT01301625

Adverse event: Angina/Chest Pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 78 at risk

Adverse event: Arrhythmias
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 78 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 78 at risk

Adverse event: Fever or Hyperthermia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 78 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 78 at risk

Adverse event: Hypotension/Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 78 at risk

Adverse event: Mitral Valve/Leaflet Injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 78 at risk

Adverse event: Other
Serious: yes
Organ System: General disorders
Frequency: 25 affected / 78 at risk

Adverse event: Renal Insufficiency or Failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 5 affected / 78 at risk

Adverse event: Respiratory Failure/Atelectasis/Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 78 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 78 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 78 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 78 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 78 at risk

Adverse event: Angina/Chest Pain
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 78 at risk

Adverse event: Arrhythmias
Serious: no
Organ System: Cardiac disorders
Frequency: 10 affected / 78 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Vascular disorders
Frequency: 24 affected / 78 at risk

Adverse event: Coagulopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 78 at risk

Adverse event: Fever or Hyperthermia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 78 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 19 affected / 78 at risk

Adverse event: Hypotension/Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 8 affected / 78 at risk

Adverse event: Infection at Access Site
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 78 at risk

Adverse event: Mitral Valve/Leaflet Injury
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 78 at risk

Adverse event: Nausea/Vomiting
Serious: no
Organ System: General disorders
Frequency: 6 affected / 78 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 47 affected / 78 at risk

Adverse event: Pain at Incision Site
Serious: no
Organ System: General disorders
Frequency: 4 affected / 78 at risk

Adverse event: Renal Insufficiency or Failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 78 at risk

Adverse event: Respiratory Failure/Atelectasis/Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 78 at risk

Adverse event: Sepsis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 78 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 78 at risk

Adverse event: Cerebrovascular accident
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 78 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 78 at risk