Study: NCT01676727

Adverse event: Stroke-TIA
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 92 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 24 affected / 92 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 92 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 12 affected / 92 at risk

Adverse event: New or worsened conduction disturbances and arrhythmias without pacemaker implant
Serious: yes
Organ System: Cardiac disorders
Frequency: 11 affected / 92 at risk

Adverse event: Permanent Pacemaker Implantation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 13 affected / 92 at risk

Adverse event: Vascular access site and access-related complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 15 affected / 92 at risk

Adverse event: Failure of current therapy for AS requiring hospitalization or worsening congestive heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 10 affected / 92 at risk

Adverse event: Sternotomy or thoracotomy related event
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 92 at risk

Adverse event: N/A
Serious: yes
Organ System: General disorders
Notes: Adverse events not associated with the use of the study device were collected without a specific adverse event term
Frequency: 55 affected / 92 at risk

Adverse event: N/A
Serious: yes
Organ System: Cardiac disorders
Notes: Adverse events not associated with the use of the study device were collected without a specific adverse event term
Frequency: 3 affected / 92 at risk

Adverse event: N/A
Serious: yes
Organ System: Infections and infestations
Notes: Adverse events not associated with the use of the study device were collected without a specific adverse event term
Frequency: 2 affected / 92 at risk

Adverse event: N/A
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Adverse events not associated with the use of the study device were collected without a specific adverse event term
Frequency: 1 affected / 92 at risk

Adverse event: N/A
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Adverse events not associated with the use of the study device were collected without a specific adverse event term
Frequency: 1 affected / 92 at risk

Adverse event: N/A
Serious: no
Organ System: Cardiac disorders
Notes: Adverse events not associated with the use of the study device were collected without a specific adverse event term
Frequency: 31 affected / 92 at risk

Adverse event: N/A
Serious: no
Organ System: General disorders
Notes: Adverse events not associated with the use of the study device were collected without a specific adverse event term
Frequency: 51 affected / 92 at risk

Adverse event: N/A
Serious: no
Organ System: Product Issues
Notes: Adverse events not associated with the use of the study device were collected without a specific adverse event term
Frequency: 1 affected / 92 at risk

Adverse event: N/A
Serious: no
Organ System: Renal and urinary disorders
Notes: Adverse events not associated with the use of the study device were collected without a specific adverse event term
Frequency: 10 affected / 92 at risk

Adverse event: N/A
Serious: no
Organ System: Infections and infestations
Notes: Adverse events not associated with the use of the study device were collected without a specific adverse event term
Frequency: 1 affected / 92 at risk

Adverse event: N/A
Serious: no
Organ System: Surgical and medical procedures
Notes: Adverse events not associated with the use of the study device were collected without a specific adverse event term
Frequency: 4 affected / 92 at risk

Adverse event: N/A
Serious: no
Organ System: Vascular disorders
Notes: Adverse events not associated with the use of the study device were collected without a specific adverse event term
Frequency: 14 affected / 92 at risk