Study: NCT02321514

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 191 at risk

Adverse event: Bleeding complications
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 191 at risk

Adverse event: Blood loss requiring transfusion
Serious: yes
Organ System: Vascular disorders
Frequency: 12 affected / 191 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 191 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 191 at risk

Adverse event: Cardiac tamponade
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 191 at risk

Adverse event: Conduction defect/cardiac arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 191 at risk

Adverse event: Decreased LV function and/or cardiac output
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 191 at risk

Adverse event: Device erosion, migration or malposition
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 191 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 191 at risk

Adverse event: Endocarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 191 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 191 at risk

Adverse event: Heart Failure, Worsening
Serious: yes
Organ System: Cardiac disorders
Frequency: 19 affected / 191 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 191 at risk

Adverse event: Infection
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 191 at risk

Adverse event: Mitral valve regurgitation, worsening
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 191 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 191 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 191 at risk

Adverse event: Pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 191 at risk

Adverse event: Prosthetic cardiac valve regurgitation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 191 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 191 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 191 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 191 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 191 at risk

Adverse event: Shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 12 affected / 191 at risk

Adverse event: Tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 191 at risk

Adverse event: Thrombosis, Device
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 191 at risk

Adverse event: Vascular & access-related complications
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 191 at risk

Adverse event: Vascular & access-related complications - Transapical
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 191 at risk

Adverse event: Other - Cardiovascular
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 191 at risk

Adverse event: Blood loss not requiring transfusion
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 191 at risk

Adverse event: Vascular & access-related complications
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 191 at risk

Adverse event: Abnormal lab values
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 191 at risk

Adverse event: Renal insufficiency or failure
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 191 at risk

Adverse event: Blood loss requiring transfusion
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 191 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 191 at risk

Adverse event: Hepatic failure
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 191 at risk

Adverse event: Nausea/Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 191 at risk

Adverse event: Pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 191 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 191 at risk

Adverse event: Other - Gastrointestinal/Digestive
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 191 at risk

Adverse event: Other - Genitourinary
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 191 at risk

Adverse event: Renal insufficiency or failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 14 affected / 191 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 191 at risk

Adverse event: Other - Genitourinary
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 191 at risk

Adverse event: Blood loss not requiring transfusion
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: HEENT- Blood loss not requiring transfusion
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 191 at risk

Adverse event: Blood loss not requiring transfusion
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 191 at risk

Adverse event: Blood loss requiring transfusion
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 191 at risk

Adverse event: Haemolysis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 191 at risk

Adverse event: Infection
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 191 at risk

Adverse event: Leukocytosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 191 at risk

Adverse event: Shock
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 191 at risk

Adverse event: Anticoagulation drug level above therapeutic
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 191 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 191 at risk

Adverse event: Other - Cytokine reaction
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 191 at risk

Adverse event: Other - Rhabdomyolysis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 191 at risk

Adverse event: Altered mental status
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 191 at risk

Adverse event: Embolism, Other
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 191 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 191 at risk

Adverse event: Other - Neurologic
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 191 at risk

Adverse event: Altered mental status
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 191 at risk

Adverse event: Blood loss requiring transfusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 191 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 191 at risk

Adverse event: Heart Failure, Worsening
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 191 at risk

Adverse event: Infection
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 191 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 191 at risk

Adverse event: Respiratory Difficulty
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 191 at risk

Adverse event: Respiratory Insufficiency/Failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 191 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 191 at risk

Adverse event: Other - Respiratory
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 191 at risk

Adverse event: Altered mental status
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: Anaemia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: HEENT- Blood loss requiring transfusion
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: Infection
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: Hepatic failure
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: Renal insufficiency or failure
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 191 at risk

Adverse event: Sepsis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: Vascular & access-related complications
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: Other - Coagulopathy- clotting disorder
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: Other - Increased CT output
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: Other - thoracic drainage
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: Other - unable to remove chest tube
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 191 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 16 affected / 191 at risk

Adverse event: Arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 16 affected / 191 at risk

Adverse event: Decreased LV function and/or cardiac output
Serious: no
Organ System: Cardiac disorders
Frequency: 11 affected / 191 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 19 affected / 191 at risk

Adverse event: Prosthetic cardiac valve regurgitation
Serious: no
Organ System: Cardiac disorders
Frequency: 14 affected / 191 at risk

Adverse event: Abnormal lab values
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 191 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 14 affected / 191 at risk

Adverse event: Other - Gastrointestinal/Digestive
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 191 at risk

Adverse event: Renal insufficiency or failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 16 affected / 191 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 13 affected / 191 at risk

Adverse event: Leukocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 191 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 19 affected / 191 at risk

Adverse event: Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 19 affected / 191 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 18 affected / 191 at risk

Adverse event: Respiratory Difficulty
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 191 at risk

Adverse event: Other - Respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 23 affected / 191 at risk