Study: NCT03222128

Adverse event: Abnormal lab value
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 22 affected / 1069 at risk

Adverse event: Access site and access related vascular injury - Dissection
Serious: yes
Organ System: Vascular disorders
Frequency: 11 affected / 1069 at risk

Adverse event: Access site and access related vascular injury - Distal embolization (noncerebral) from vascular sou
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1069 at risk

Adverse event: Access site and access related vascular injury - Failure of percutaneous access site closure
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: resulting in intervention
Frequency: 8 affected / 1069 at risk

Adverse event: Access site and access related vascular injury - Hematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 1069 at risk

Adverse event: Access site and access related vascular injury - Other
Serious: yes
Organ System: Vascular disorders
Frequency: 8 affected / 1069 at risk

Adverse event: Access site and access related vascular injury - Perforation
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 1069 at risk

Adverse event: Access site and access related vascular injury - Pseudoaneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 1069 at risk

Adverse event: Access site and access related vascular injury - Rupture
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1069 at risk

Adverse event: Access site and access related vascular injury - Stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 1069 at risk

Adverse event: Access site and access related vascular injury - Ventricular rupture (Apical rupture)
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 1069 at risk

Adverse event: Anemia/Hemolytic anemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 25 affected / 1069 at risk

Adverse event: Anesthesia related complication - Confusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1069 at risk

Adverse event: Anesthesia related complication - Other
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1069 at risk

Adverse event: Angina/Cardiac chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 16 affected / 1069 at risk

Adverse event: Aortic valve stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1069 at risk

Adverse event: Aortic insufficiency/Regurgitation PV leak - Non structural dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 1069 at risk

Adverse event: Aortic insufficiency/Regurgitation PV leak - Structural dysfunction
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1069 at risk

Adverse event: Aortic insufficiency/Regurgitation non valvular cause
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1069 at risk

Adverse event: Arrhythmia/Conduction system injury (defect)
Serious: yes
Organ System: Cardiac disorders
Frequency: 195 affected / 1069 at risk

Adverse event: Bleeding - Hemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 111 affected / 1069 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 17 affected / 1069 at risk

Adverse event: Cardiac tamponade/Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 14 affected / 1069 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1069 at risk

Adverse event: Carotid artery disease
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 1069 at risk

Adverse event: Coronary artery disease/Coronary ischemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 1069 at risk

Adverse event: Coronary flow obstruction/Transvalvular flow disturbance
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1069 at risk

Adverse event: Delirium
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 1069 at risk

Adverse event: Device migration/malposition requiring intervention
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 1069 at risk

Adverse event: Oedema
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 1069 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 1069 at risk

Adverse event: Exercise intolerance or weakness
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 1069 at risk

Adverse event: Gastro Intestinal event - Non-hemorrhagic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 31 affected / 1069 at risk

Adverse event: Genito-Urinary event - Non-hemorrhagic
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 17 affected / 1069 at risk

Adverse event: Heart failure/CHF/Low output failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 76 affected / 1069 at risk

Adverse event: Haemolysis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1069 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 10 affected / 1069 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 11 affected / 1069 at risk

Adverse event: Infection - Access site infection
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 1069 at risk

Adverse event: Infection - Bacteremia
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 1069 at risk

Adverse event: Infection - Endocarditis
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 1069 at risk

Adverse event: Infection - Other
Serious: yes
Organ System: Infections and infestations
Frequency: 26 affected / 1069 at risk

Adverse event: Infection - Respiratory infection
Serious: yes
Organ System: Infections and infestations
Frequency: 55 affected / 1069 at risk

Adverse event: Infection - Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 28 affected / 1069 at risk

Adverse event: Infection - Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 20 affected / 1069 at risk

Adverse event: Ischaemia
Serious: yes
Organ System: Investigations
Frequency: 8 affected / 1069 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 13 affected / 1069 at risk

Adverse event: Mental state change (not neurological) - Confusion
Serious: yes
Organ System: Investigations
Frequency: 5 affected / 1069 at risk

Adverse event: Mental state change (not neurological) - Dementia
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 1069 at risk

Adverse event: Mental state change (not neurological) - Depression
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 1069 at risk

Adverse event: Miscellaneous - Cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 17 affected / 1069 at risk

Adverse event: Miscellaneous - Drug reaction
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 1069 at risk

Adverse event: Miscellaneous - Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 23 affected / 1069 at risk

Adverse event: Miscellaneous - Other
Serious: yes
Organ System: General disorders
Frequency: 15 affected / 1069 at risk

Adverse event: Miscellaneous - Suicide
Serious: yes
Organ System: Social circumstances
Frequency: 1 affected / 1069 at risk

Adverse event: Mitral valve injury or insufficiency
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 1069 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1069 at risk

Adverse event: Musculoskeletal - Fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 33 affected / 1069 at risk

Adverse event: Musculoskeletal - Pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 25 affected / 1069 at risk

Adverse event: Neurological - Change in level of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1069 at risk

Adverse event: Neurological - Cognitive impairment
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 1069 at risk

Adverse event: Neurological - Dysphasia/Aphasia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1069 at risk

Adverse event: Neurological - Hemiparesis (One sided body weakness)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1069 at risk

Adverse event: Neurological - Hemorrhagic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 8 affected / 1069 at risk

Adverse event: Neurological - Ischemic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 24 affected / 1069 at risk

Adverse event: Neurological - Other
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 1069 at risk

Adverse event: Neurological - Other new neurological sign consistent with stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1069 at risk

Adverse event: Neurological - TIA
Serious: yes
Organ System: Nervous system disorders
Frequency: 10 affected / 1069 at risk

Adverse event: Neurological - Undetermined stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 7 affected / 1069 at risk

Adverse event: Pericarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1069 at risk

Adverse event: Renal insufficiency or renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 31 affected / 1069 at risk

Adverse event: Respiratory event - Aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1069 at risk

Adverse event: Respiratory event - Atelectasis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1069 at risk

Adverse event: Respiratory event - Dyspnea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 1069 at risk

Adverse event: Respiratory event - Other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 17 affected / 1069 at risk

Adverse event: Respiratory event - Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1069 at risk

Adverse event: Respiratory event - Pulmonary edema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1069 at risk

Adverse event: Respiratory event - Pulmonary effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 17 affected / 1069 at risk

Adverse event: Respiratory event - Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 32 affected / 1069 at risk

Adverse event: Syncope
Serious: yes
Organ System: Vascular disorders
Frequency: 14 affected / 1069 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 1069 at risk

Adverse event: Embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 13 affected / 1069 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 1069 at risk

Adverse event: Valve thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1069 at risk

Adverse event: Vascular complication - Non-access related
Serious: yes
Organ System: Vascular disorders
Frequency: 16 affected / 1069 at risk

Adverse event: Other
Serious: yes
Organ System: General disorders
Frequency: 38 affected / 1069 at risk

Adverse event: Abnormal lab value
Serious: no
Organ System: Investigations
Frequency: 144 affected / 1069 at risk

Adverse event: Anemia/Hemolytic anemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 128 affected / 1069 at risk

Adverse event: Aortic insufficiency/Regurgitation PV leak - Non structural dysfunction
Serious: no
Organ System: Cardiac disorders
Frequency: 55 affected / 1069 at risk

Adverse event: Arrhythmia/Conduction system injury (defect)
Serious: no
Organ System: Cardiac disorders
Frequency: 299 affected / 1069 at risk

Adverse event: Bleeding - Hemorrhage
Serious: no
Organ System: Vascular disorders
Frequency: 212 affected / 1069 at risk

Adverse event: Gastro Intestinal event - Non-hemorrhagic
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 66 affected / 1069 at risk

Adverse event: Genito-Urinary event - Non-hemorrhagic
Serious: no
Organ System: Renal and urinary disorders
Frequency: 83 affected / 1069 at risk

Adverse event: Heart failure/CHF/Low output failure
Serious: no
Organ System: Cardiac disorders
Frequency: 95 affected / 1069 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 57 affected / 1069 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 63 affected / 1069 at risk

Adverse event: Infection - Other
Serious: no
Organ System: Infections and infestations
Frequency: 55 affected / 1069 at risk

Adverse event: Infection - Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 87 affected / 1069 at risk

Adverse event: Miscellaneous - Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 70 affected / 1069 at risk

Adverse event: Miscellaneous - Other
Serious: no
Organ System: Investigations
Frequency: 65 affected / 1069 at risk

Adverse event: Musculoskeletal - Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 81 affected / 1069 at risk

Adverse event: Renal insufficiency or renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 117 affected / 1069 at risk

Adverse event: Respiratory event - Pulmonary effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 63 affected / 1069 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 101 affected / 1069 at risk

Adverse event: Other
Serious: no
Organ System: Investigations
Frequency: 111 affected / 1069 at risk