Study: NCT03222141

Adverse event: Any Adverse Event
Serious: yes
Organ System: Investigations
Frequency: 6 affected / 583 at risk

Adverse event: Access site and access related vascular injury - Aortic root rupture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 583 at risk

Adverse event: Access site and access related vascular injury - Dissection
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 583 at risk

Adverse event: Access site and access related vascular injury - Distal embolization (noncerebral) from vascular sou
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 583 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: 5 affected / 583 at risk

Adverse event: Access site and access related vascular injury - Hematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 583 at risk

Adverse event: Access site and access related vascular injury - Other
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 583 at risk

Adverse event: Access site and access related vascular injury - Perforation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 583 at risk

Adverse event: Access site and access related vascular injury - Pseudoaneurysm
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 583 at risk

Adverse event: Access site and access related vascular injury - Stenosis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 583 at risk

Adverse event: Access site and access related vascular injury - Thoracic aortic dissection
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 583 at risk

Adverse event: Access site and access related vascular injury - Ventricular rupture (Apical rupture)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 583 at risk

Adverse event: Anemia/Hemolytic anemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 583 at risk

Adverse event: Angina/Cardiac chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 583 at risk

Adverse event: Aortic insufficiency/Regurgitation PV leak - Non structural dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 583 at risk

Adverse event: Aortic insufficiency/Regurgitation non valvular cause
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 583 at risk

Adverse event: Arrhythmia/Conduction system injury (defect)
Serious: yes
Organ System: Cardiac disorders
Frequency: 105 affected / 583 at risk

Adverse event: Bleeding - Hemorrhage
Serious: yes
Organ System: General disorders
Frequency: 41 affected / 583 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 583 at risk

Adverse event: Cardiac tamponade
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 583 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 583 at risk

Adverse event: Delirium
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 583 at risk

Adverse event: Device embolisation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 583 at risk

Adverse event: Device migration/malposition requiring intervention
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 583 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 583 at risk

Adverse event: Exercise intolerance or weakness
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 583 at risk

Adverse event: Gastro Intestinal event - Non-hemorrhagic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 583 at risk

Adverse event: Genito-Urinary event - Non-hemorrhagic
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 583 at risk

Adverse event: Heart failure/CHF/Low output failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 29 affected / 583 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 583 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 583 at risk

Adverse event: Infection - Access site infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 583 at risk

Adverse event: Infection - Bacteremia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 583 at risk

Adverse event: Infection - Other
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 583 at risk

Adverse event: Infection - Respiratory infection
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 583 at risk

Adverse event: Infection - Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 583 at risk

Adverse event: Infection - Urinary tract infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 6 affected / 583 at risk

Adverse event: Ischaemia
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 583 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 583 at risk

Adverse event: Mental state change (not neurological) - Confusion
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 583 at risk

Adverse event: Mental state change (not neurological) - Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 583 at risk

Adverse event: Miscellaneous - Cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 583 at risk

Adverse event: Miscellaneous - Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 583 at risk

Adverse event: Miscellaneous - Other
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 583 at risk

Adverse event: Musculoskeletal - Fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 583 at risk

Adverse event: Musculoskeletal - Pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 583 at risk

Adverse event: Neurological - Dysphasia/Aphasia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 583 at risk

Adverse event: Neurological - Hemiparesis (One sided body weakness)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 583 at risk

Adverse event: Neurological - Ischemic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 7 affected / 583 at risk

Adverse event: Neurological - Sensory loss on one side of body
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 583 at risk

Adverse event: Neurological - TIA
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 583 at risk

Adverse event: Neurological - Undetermined stroke
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 583 at risk

Adverse event: Renal insufficiency or renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 15 affected / 583 at risk

Adverse event: Respiratory event - Dyspnea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 583 at risk

Adverse event: Respiratory event - Other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 583 at risk

Adverse event: Respiratory event - Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 583 at risk

Adverse event: Respiratory event - Pulmonary effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 17 affected / 583 at risk

Adverse event: Respiratory event - Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 583 at risk

Adverse event: Syncope
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 583 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 583 at risk

Adverse event: Embolism
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 583 at risk

Adverse event: Death
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 583 at risk

Adverse event: Vascular complication - Non-access related
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 583 at risk

Adverse event: Other
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 583 at risk

Adverse event: Abnormal lab value
Serious: no
Organ System: Investigations
Frequency: 71 affected / 583 at risk

Adverse event: Anemia/Hemolytic anemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 54 affected / 583 at risk

Adverse event: Arrhythmia/Conduction system injury (defect)
Serious: no
Organ System: Cardiac disorders
Frequency: 128 affected / 583 at risk

Adverse event: Bleeding - Hemorrhage
Serious: no
Organ System: Vascular disorders
Frequency: 118 affected / 583 at risk

Adverse event: Heart failure/CHF/Low output failure
Serious: no
Organ System: Cardiac disorders
Frequency: 41 affected / 583 at risk

Adverse event: Renal insufficiency or renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 54 affected / 583 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 40 affected / 583 at risk

Adverse event: Other
Serious: no
Organ System: Investigations
Frequency: 41 affected / 583 at risk