Study: NCT02687035

Adverse event: Conduction/native pacer disturbance requiring pacemaker
Serious: yes
Organ System: Cardiac disorders
Frequency: 219 affected / 1814 at risk

Adverse event: Non-valve Related Readmission
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 354 affected / 1814 at risk

Adverse event: Unplanned Vascular Surgery or Intervention
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 53 affected / 1814 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 49 affected / 1814 at risk

Adverse event: Perforation with or w/o Tamponade
Serious: yes
Organ System: Vascular disorders
Frequency: 25 affected / 1814 at risk

Adverse event: Major Vascular Complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 20 affected / 1814 at risk

Adverse event: Unplanned Other Cardiac Surgery or Intervention
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 29 affected / 1814 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 16 affected / 1814 at risk

Adverse event: Percutaneous coronary intervention
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 22 affected / 1814 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 17 affected / 1814 at risk

Adverse event: Conduction/native pacer disturbance requiring Implantable Cardioverter Defibrillator
Serious: yes
Organ System: Cardiac disorders
Frequency: 13 affected / 1814 at risk

Adverse event: Major Bleeding Event
Serious: yes
Organ System: Vascular disorders
Frequency: 32 affected / 1814 at risk

Adverse event: Retroperitoneal haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 6 affected / 1814 at risk

Adverse event: Aortic dissection
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 1814 at risk

Adverse event: Valve Related Readmission
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 15 affected / 1814 at risk

Adverse event: Coronary Compression or Obstruction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1814 at risk

Adverse event: Life Threatening Bleeding
Serious: yes
Organ System: Vascular disorders
Frequency: 8 affected / 1814 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 1814 at risk

Adverse event: New Requirement for Dialysis
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 3 affected / 1814 at risk

Adverse event: Haemorrhagic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 1814 at risk

Adverse event: Annular Dissection
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1814 at risk

Adverse event: Device Embolization Left Ventricle
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1814 at risk

Adverse event: Aortic Valve Re-intervention
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 6 affected / 1814 at risk

Adverse event: Endocarditis
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 1814 at risk