Study: NCT03752866

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 501 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 501 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 501 at risk

Adverse event: Aortic Valve Regurgitation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 501 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 501 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 501 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 501 at risk

Adverse event: Cardiac Arrhythmias
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 501 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 501 at risk

Adverse event: Atrioventricular block complete
Serious: yes
Organ System: Cardiac disorders
Frequency: 59 affected / 501 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 10 affected / 501 at risk

Adverse event: Death - Unknown
Serious: yes
Organ System: Cardiac disorders
Frequency: 18 affected / 501 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 501 at risk

Adverse event: Endocarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 501 at risk

Adverse event: First Degree Heart Block
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 501 at risk

Adverse event: Bundle branch block left
Serious: yes
Organ System: Cardiac disorders
Frequency: 13 affected / 501 at risk

Adverse event: Mitral valve incompetence
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 501 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 501 at risk

Adverse event: Myocardial ischaemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 501 at risk

Adverse event: Other
Serious: yes
Organ System: Cardiac disorders
Frequency: 34 affected / 501 at risk

Adverse event: Prosthetic cardiac valve regurgitation
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 501 at risk

Adverse event: Cardiac tamponade
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 501 at risk

Adverse event: Second Degree Heart Block
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 501 at risk

Adverse event: Ventricular fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 501 at risk

Adverse event: Other
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 501 at risk

Adverse event: Ischaemia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 501 at risk

Adverse event: Other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 501 at risk

Adverse event: Death - Unknown
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 501 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 501 at risk

Adverse event: Other
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 501 at risk

Adverse event: Other
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 501 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 501 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 501 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 11 affected / 501 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 501 at risk

Adverse event: Other
Serious: yes
Organ System: Infections and infestations
Frequency: 10 affected / 501 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 501 at risk

Adverse event: Urinary Tract Infection/UTI
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 501 at risk

Adverse event: Annulus Rupture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 501 at risk

Adverse event: Valve Migration
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 501 at risk

Adverse event: Other
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 501 at risk

Adverse event: Death - Unknown
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 501 at risk

Adverse event: Other
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 501 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 14 affected / 501 at risk

Adverse event: Transient Ischemic Attack (TIA)
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 501 at risk

Adverse event: Other
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 501 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 5 affected / 501 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 501 at risk

Adverse event: Other
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 5 affected / 501 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 501 at risk

Adverse event: Renal Insufficiency/Worsening Renal Function
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 6 affected / 501 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 501 at risk

Adverse event: Other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 501 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 501 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 501 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 501 at risk

Adverse event: Other
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 501 at risk

Adverse event: Access Site Bleeding Event
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 501 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 14 affected / 501 at risk

Adverse event: Death - Unknown
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 501 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 501 at risk

Adverse event: Ischaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 501 at risk

Adverse event: Other
Serious: yes
Organ System: Vascular disorders
Frequency: 8 affected / 501 at risk

Adverse event: Vascular pseudoaneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 501 at risk

Adverse event: Vascular Access Site And Access Related Complications
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 501 at risk

Adverse event: Vascular Perforation
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 501 at risk

Adverse event: Vascular stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 501 at risk

Adverse event: Vessel Occlusion
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 501 at risk

Adverse event: Bundle branch block left
Serious: no
Organ System: Cardiac disorders
Frequency: 72 affected / 501 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 500 at risk

Adverse event: Other
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 500 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 500 at risk

Adverse event: Aortic Valve Regurgitation
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 500 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 12 affected / 500 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 500 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 500 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 500 at risk

Adverse event: Cardiac Arrhythmias
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 500 at risk

Adverse event: Atrioventricular block complete
Serious: yes
Organ System: Cardiac disorders
Frequency: 49 affected / 500 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 15 affected / 500 at risk

Adverse event: Death - Unknown
Serious: yes
Organ System: Cardiac disorders
Frequency: 16 affected / 500 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 500 at risk

Adverse event: Endocarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 500 at risk

Adverse event: First Degree Heart Block
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 500 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 500 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 500 at risk

Adverse event: Bundle branch block left
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 500 at risk

Adverse event: Mitral valve incompetence
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 500 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 500 at risk

Adverse event: Other
Serious: yes
Organ System: Cardiac disorders
Frequency: 32 affected / 500 at risk

Adverse event: Prosthetic cardiac valve regurgitation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 500 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 500 at risk

Adverse event: Cardiac tamponade
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 500 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 500 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 500 at risk

Adverse event: Second Degree Heart Block
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 500 at risk

Adverse event: Thrombus On Device
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 500 at risk

Adverse event: Valve Embolization
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 500 at risk

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 500 at risk

Adverse event: Other
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 500 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 500 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 500 at risk

Adverse event: Other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 500 at risk

Adverse event: Asthenia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 500 at risk

Adverse event: Death - Unknown
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 500 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 500 at risk

Adverse event: Other
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 500 at risk

Adverse event: Death - Unknown
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 500 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 21 affected / 500 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 500 at risk

Adverse event: Other
Serious: yes
Organ System: Infections and infestations
Frequency: 9 affected / 500 at risk

Adverse event: Renal Insufficiency/Worsening Renal Function
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 500 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 500 at risk

Adverse event: Urinary Tract Infection/UTI
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 500 at risk

Adverse event: Valve Embolization
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 500 at risk

Adverse event: Valve Migration
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 500 at risk

Adverse event: Other
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 500 at risk

Adverse event: Other
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 500 at risk

Adverse event: Death - Unknown
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 500 at risk

Adverse event: Death - Unknown
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 500 at risk

Adverse event: Other
Serious: yes
Organ System: Nervous system disorders
Frequency: 8 affected / 500 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 16 affected / 500 at risk

Adverse event: Transient Ischemic Attack (TIA)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 500 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 5 affected / 500 at risk

Adverse event: Other
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 500 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 5 affected / 500 at risk

Adverse event: Renal Insufficiency/Worsening Renal Function
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 500 at risk

Adverse event: Other
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 500 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 500 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 500 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 500 at risk

Adverse event: Other
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 500 at risk

Adverse event: Other
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 500 at risk

Adverse event: Access Site Bleeding Event
Serious: yes
Organ System: Vascular disorders
Frequency: 8 affected / 500 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 12 affected / 500 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 500 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 500 at risk

Adverse event: Ischaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 500 at risk

Adverse event: Other
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 500 at risk

Adverse event: Vascular pseudoaneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 500 at risk

Adverse event: Vascular Access Site And Access Related Complications
Serious: yes
Organ System: Vascular disorders
Frequency: 6 affected / 500 at risk

Adverse event: Vascular Perforation
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 500 at risk

Adverse event: Vascular stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 500 at risk

Adverse event: Bundle branch block left
Serious: no
Organ System: Cardiac disorders
Frequency: 80 affected / 500 at risk