Trial Outcomes & Findings for CoreValve® System Australia/New Zealand Clinical Study (NCT NCT01015612)
NCT ID: NCT01015612
Last Updated: 2019-11-12
Results Overview
Defined as a composite of all cause death, myocardial infarction(MI) (Q-wave \& non-Q-wave), stroke, and re-intervention (defined as any emergent cardiac surgery or percutaneous re-intervention catheter procedure that repairs, otherwise alters or adjusts or replaces a previously implanted valve)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
634 participants
Primary outcome timeframe
30 days
Results posted on
2019-11-12
Participant Flow
Participant milestones
| Measure |
Medtronic CoreValve® System Implantation
Patients with symptomatic severe aortic stenosis who have an elevated surgical risk
Medtronic CoreValve® System: The Medtronic CoreValve® System device is designed to replace the native aortic valve without the requirement for open heart surgery and without concomitant surgical removal of the failed native valve in patients with symptomatic severe aortic stenosis who have an elevated surgical risk
|
|---|---|
|
Overall Study
STARTED
|
634
|
|
Overall Study
COMPLETED
|
481
|
|
Overall Study
NOT COMPLETED
|
153
|
Reasons for withdrawal
| Measure |
Medtronic CoreValve® System Implantation
Patients with symptomatic severe aortic stenosis who have an elevated surgical risk
Medtronic CoreValve® System: The Medtronic CoreValve® System device is designed to replace the native aortic valve without the requirement for open heart surgery and without concomitant surgical removal of the failed native valve in patients with symptomatic severe aortic stenosis who have an elevated surgical risk
|
|---|---|
|
Overall Study
Death
|
113
|
|
Overall Study
Withdrawal by Subject
|
40
|
Baseline Characteristics
CoreValve® System Australia/New Zealand Clinical Study
Baseline characteristics by cohort
| Measure |
Medtronic CoreValve® System Implantation
n=634 Participants
Patients with symptomatic severe aortic stenosis who have an elevated surgical risk
Medtronic CoreValve® System: The Medtronic CoreValve® System device is designed to replace the native aortic valve without the requirement for open heart surgery and without concomitant surgical removal of the failed native valve in patients with symptomatic severe aortic stenosis who have an elevated surgical risk
|
|---|---|
|
Age, Continuous
|
84.1 years
STANDARD_DEVIATION 5.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
281 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
353 Participants
n=5 Participants
|
|
Region of Enrollment
New Zealand
|
111 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
523 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 daysDefined as a composite of all cause death, myocardial infarction(MI) (Q-wave \& non-Q-wave), stroke, and re-intervention (defined as any emergent cardiac surgery or percutaneous re-intervention catheter procedure that repairs, otherwise alters or adjusts or replaces a previously implanted valve)
Outcome measures
| Measure |
Medtronic CoreValve® System Implantation
n=634 Participants
Patients with symptomatic severe aortic stenosis who have an elevated surgical risk
Medtronic CoreValve® System: The Medtronic CoreValve® System device is designed to replace the native aortic valve without the requirement for open heart surgery and without concomitant surgical removal of the failed native valve in patients with symptomatic severe aortic stenosis who have an elevated surgical risk
|
|---|---|
|
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) Rate
|
0.099 probability of events at 30 days
|
PRIMARY outcome
Timeframe: 24-48 hours after the procedure or before the discharge* Vascular access, delivery and deployment of the device, and retrieval of the delivery system * Correct position of the device in the proper anatomical location (placement in the annulus with no impedance on device function) * Intended performance of the prosthetic valve (aortic valve area \> 1.2 cm2 (by echocardiography using the continuity equation) and mean aortic valve gradient \< 20 mmHg, without moderate or severe prosthetic valve aortic regurgitation) * Only one valve implanted * No occurrence of in-hospital MACCE
Outcome measures
| Measure |
Medtronic CoreValve® System Implantation
n=634 Participants
Patients with symptomatic severe aortic stenosis who have an elevated surgical risk
Medtronic CoreValve® System: The Medtronic CoreValve® System device is designed to replace the native aortic valve without the requirement for open heart surgery and without concomitant surgical removal of the failed native valve in patients with symptomatic severe aortic stenosis who have an elevated surgical risk
|
|---|---|
|
Percentage of Participants With Overall Device Success
|
52.6 % of participants with device success
|
PRIMARY outcome
Timeframe: 30 daysDefined as all death resulting from a cardiac cause or complications of a cardiac procedure and / or death of an unknown cause; this category includes valve-related deaths and non-valve-related cardiac deaths (e.g. congestive heart failure, acute myocardial infarction, documented fatal arrhythmias).
Outcome measures
| Measure |
Medtronic CoreValve® System Implantation
n=634 Participants
Patients with symptomatic severe aortic stenosis who have an elevated surgical risk
Medtronic CoreValve® System: The Medtronic CoreValve® System device is designed to replace the native aortic valve without the requirement for open heart surgery and without concomitant surgical removal of the failed native valve in patients with symptomatic severe aortic stenosis who have an elevated surgical risk
|
|---|---|
|
Cardiac-related Death
|
0.035 probability of events at 30 days
|
SECONDARY outcome
Timeframe: 30 daysis defined per Valve Academic Research Consortium-1 consensus document (VARC-1), including Cardiovascular and non-cardiovascular mortality.
Outcome measures
| Measure |
Medtronic CoreValve® System Implantation
n=634 Participants
Patients with symptomatic severe aortic stenosis who have an elevated surgical risk
Medtronic CoreValve® System: The Medtronic CoreValve® System device is designed to replace the native aortic valve without the requirement for open heart surgery and without concomitant surgical removal of the failed native valve in patients with symptomatic severe aortic stenosis who have an elevated surgical risk
|
|---|---|
|
All-Cause Mortality
|
0.038 probability of events at 30 days
|
SECONDARY outcome
Timeframe: 30 daysIncluded Q-wave and non-Q-wave.
Outcome measures
| Measure |
Medtronic CoreValve® System Implantation
n=634 Participants
Patients with symptomatic severe aortic stenosis who have an elevated surgical risk
Medtronic CoreValve® System: The Medtronic CoreValve® System device is designed to replace the native aortic valve without the requirement for open heart surgery and without concomitant surgical removal of the failed native valve in patients with symptomatic severe aortic stenosis who have an elevated surgical risk
|
|---|---|
|
Myocardial Infarction
|
0.021 probability of events at 30 days
|
SECONDARY outcome
Timeframe: 30 daysIs a neurological deficit lasting more than 24 hours, or lasting 24 hours or less with a brain imaging study showing infarction.
Outcome measures
| Measure |
Medtronic CoreValve® System Implantation
n=634 Participants
Patients with symptomatic severe aortic stenosis who have an elevated surgical risk
Medtronic CoreValve® System: The Medtronic CoreValve® System device is designed to replace the native aortic valve without the requirement for open heart surgery and without concomitant surgical removal of the failed native valve in patients with symptomatic severe aortic stenosis who have an elevated surgical risk
|
|---|---|
|
Stroke
|
0.043 probability of events at 30 days
|
SECONDARY outcome
Timeframe: 30 daysAny emergent surgical or percutaneous interventional catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve.
Outcome measures
| Measure |
Medtronic CoreValve® System Implantation
n=634 Participants
Patients with symptomatic severe aortic stenosis who have an elevated surgical risk
Medtronic CoreValve® System: The Medtronic CoreValve® System device is designed to replace the native aortic valve without the requirement for open heart surgery and without concomitant surgical removal of the failed native valve in patients with symptomatic severe aortic stenosis who have an elevated surgical risk
|
|---|---|
|
Re-intervention
|
0.019 probability of events at 30 days
|
Adverse Events
Medtronic CoreValve® System Implantation
Serious events: 534 serious events
Other events: 583 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Medtronic CoreValve® System Implantation
n=634 participants at risk
Patients with symptomatic severe aortic stenosis who have an elevated surgical risk
Medtronic CoreValve® System: The Medtronic CoreValve® System device is designed to replace the native aortic valve without the requirement for open heart surgery and without concomitant surgical removal of the failed native valve in patients with symptomatic severe aortic stenosis who have an elevated surgical risk
|
|---|---|
|
General disorders
Fatigue
|
0.95%
6/634 • Number of events 6 • 24 months
|
|
Infections and infestations
Hospital acquired pneumonia
|
0.95%
6/634 • Number of events 6 • 24 months
|
|
Infections and infestations
Upper respiratory tract infection
|
0.95%
6/634 • Number of events 7 • 24 months
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.95%
6/634 • Number of events 6 • 24 months
|
|
Vascular disorders
Iliac artery perforation
|
0.95%
6/634 • Number of events 6 • 24 months
|
|
Cardiac disorders
Asystole
|
0.79%
5/634 • Number of events 5 • 24 months
|
|
Cardiac disorders
Atrial flutter
|
0.79%
5/634 • Number of events 6 • 24 months
|
|
Gastrointestinal disorders
Gastrointestinal polyp
|
0.79%
5/634 • Number of events 6 • 24 months
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.79%
5/634 • Number of events 6 • 24 months
|
|
Infections and infestations
Lower respiratory tract infection
|
0.79%
5/634 • Number of events 6 • 24 months
|
|
Infections and infestations
Vascular access site infection
|
0.79%
5/634 • Number of events 5 • 24 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.79%
5/634 • Number of events 5 • 24 months
|
|
Metabolism and nutrition disorders
Gout
|
0.79%
5/634 • Number of events 6 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.79%
5/634 • Number of events 7 • 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.79%
5/634 • Number of events 6 • 24 months
|
|
Renal and urinary disorders
Urinary retention
|
0.79%
5/634 • Number of events 5 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive airways disease exacerbated
|
0.79%
5/634 • Number of events 9 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.79%
5/634 • Number of events 5 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.79%
5/634 • Number of events 6 • 24 months
|
|
Vascular disorders
Hypertension
|
0.79%
5/634 • Number of events 5 • 24 months
|
|
Cardiac disorders
Cardiac failure chronic
|
0.63%
4/634 • Number of events 4 • 24 months
|
|
Cardiac disorders
Coronary artery disease
|
0.63%
4/634 • Number of events 4 • 24 months
|
|
Cardiac disorders
Ischaemic mitral regurgitation
|
0.63%
4/634 • Number of events 5 • 24 months
|
|
Cardiac disorders
Pericardial effusion
|
0.63%
4/634 • Number of events 5 • 24 months
|
|
Cardiac disorders
Ventricular fibrillation
|
0.63%
4/634 • Number of events 4 • 24 months
|
|
Gastrointestinal disorders
Right inguinal hernia
|
0.63%
4/634 • Number of events 4 • 24 months
|
|
Gastrointestinal disorders
Upper gastrointestinal bleeding
|
0.63%
4/634 • Number of events 4 • 24 months
|
|
General disorders
Pain
|
0.63%
4/634 • Number of events 4 • 24 months
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.63%
4/634 • Number of events 4 • 24 months
|
|
Cardiac disorders
Atrioventricular block
|
19.7%
125/634 • Number of events 126 • 24 months
|
|
Cardiac disorders
Cardiac failure congestive
|
13.2%
84/634 • Number of events 120 • 24 months
|
|
Blood and lymphatic system disorders
Anaemia
|
9.0%
57/634 • Number of events 71 • 24 months
|
|
Cardiac disorders
Atrial fibrillation
|
7.1%
45/634 • Number of events 53 • 24 months
|
|
Renal and urinary disorders
Renal failure
|
6.6%
42/634 • Number of events 46 • 24 months
|
|
Infections and infestations
Pneumonia
|
6.5%
41/634 • Number of events 50 • 24 months
|
|
Nervous system disorders
Cerebrovascular accident
|
6.3%
40/634 • Number of events 42 • 24 months
|
|
Cardiac disorders
Angina Pectoris
|
4.9%
31/634 • Number of events 37 • 24 months
|
|
Cardiac disorders
Cardiac failure
|
4.9%
31/634 • Number of events 35 • 24 months
|
|
Cardiac disorders
Myocardial infarction
|
4.9%
31/634 • Number of events 35 • 24 months
|
|
Cardiac disorders
Paravalvular aortic regurgitation
|
4.7%
30/634 • Number of events 30 • 24 months
|
|
Vascular disorders
Hypotension
|
4.3%
27/634 • Number of events 30 • 24 months
|
|
Cardiac disorders
Bundle branch block left
|
3.6%
23/634 • Number of events 23 • 24 months
|
|
Vascular disorders
Haematoma
|
3.5%
22/634 • Number of events 22 • 24 months
|
|
Cardiac disorders
Bradycardia
|
3.0%
19/634 • Number of events 19 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
3.0%
19/634 • Number of events 20 • 24 months
|
|
Infections and infestations
Sepsis
|
2.8%
18/634 • Number of events 20 • 24 months
|
|
Infections and infestations
Urinary tract infection
|
2.7%
17/634 • Number of events 17 • 24 months
|
|
General disorders
Non-cardiac chest pain
|
2.4%
15/634 • Number of events 18 • 24 months
|
|
General disorders
Vascular access site pseudoaneurysm
|
2.4%
15/634 • Number of events 16 • 24 months
|
|
Injury, poisoning and procedural complications
Fall
|
2.2%
14/634 • Number of events 15 • 24 months
|
|
Injury, poisoning and procedural complications
Fractured neck of femur
|
2.2%
14/634 • Number of events 14 • 24 months
|
|
Injury, poisoning and procedural complications
Vascular access site haemorrhage
|
2.1%
13/634 • Number of events 13 • 24 months
|
|
Nervous system disorders
Syncope
|
2.1%
13/634 • Number of events 13 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.1%
13/634 • Number of events 15 • 24 months
|
|
Infections and infestations
Cellulitis
|
1.9%
12/634 • Number of events 14 • 24 months
|
|
Gastrointestinal disorders
Gastrointestinal bleed
|
1.7%
11/634 • Number of events 14 • 24 months
|
|
Nervous system disorders
Transient ischaemic attack
|
1.7%
11/634 • Number of events 12 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.7%
11/634 • Number of events 13 • 24 months
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
1.6%
10/634 • Number of events 10 • 24 months
|
|
General disorders
Multi-organ disorder
|
1.6%
10/634 • Number of events 10 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.6%
10/634 • Number of events 12 • 24 months
|
|
Cardiac disorders
Cardiac tamponade
|
1.4%
9/634 • Number of events 9 • 24 months
|
|
Cardiac disorders
Cardiogenic shock
|
1.4%
9/634 • Number of events 9 • 24 months
|
|
Cardiac disorders
Ventricular failure
|
1.4%
9/634 • Number of events 9 • 24 months
|
|
Infections and infestations
Infection
|
1.4%
9/634 • Number of events 10 • 24 months
|
|
Injury, poisoning and procedural complications
Vascular access site haematoma
|
1.4%
9/634 • Number of events 9 • 24 months
|
|
Investigations
Haemoglobin decreased
|
1.4%
9/634 • Number of events 9 • 24 months
|
|
Product Issues
Paravalvular leak
|
1.4%
9/634 • Number of events 9 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.4%
9/634 • Number of events 9 • 24 months
|
|
Vascular disorders
Postural hypotension
|
1.4%
9/634 • Number of events 10 • 24 months
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
1.3%
8/634 • Number of events 9 • 24 months
|
|
Cardiac disorders
Cardiac arrest
|
1.3%
8/634 • Number of events 8 • 24 months
|
|
Cardiac disorders
Sinus node dysfunction
|
1.3%
8/634 • Number of events 8 • 24 months
|
|
Gastrointestinal disorders
Melaena
|
1.3%
8/634 • Number of events 9 • 24 months
|
|
Infections and infestations
Diverticulitis
|
1.3%
8/634 • Number of events 8 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration pneumonia
|
1.3%
8/634 • Number of events 8 • 24 months
|
|
Vascular disorders
Femoral artery dissection
|
1.3%
8/634 • Number of events 8 • 24 months
|
|
Cardiac disorders
Ventricular tachycardia
|
1.1%
7/634 • Number of events 7 • 24 months
|
|
Psychiatric disorders
Confusional state
|
1.1%
7/634 • Number of events 7 • 24 months
|
|
Renal and urinary disorders
Haematuria
|
1.1%
7/634 • Number of events 7 • 24 months
|
|
Cardiac disorders
Left ventricular failure
|
0.95%
6/634 • Number of events 6 • 24 months
|
|
Injury, poisoning and procedural complications
Laceration
|
0.63%
4/634 • Number of events 4 • 24 months
|
|
Injury, poisoning and procedural complications
Subarachnoid haemorrhage
|
0.63%
4/634 • Number of events 4 • 24 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.63%
4/634 • Number of events 4 • 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.63%
4/634 • Number of events 5 • 24 months
|
|
Nervous system disorders
Dizziness
|
0.63%
4/634 • Number of events 5 • 24 months
|
|
Nervous system disorders
Presyncope
|
0.63%
4/634 • Number of events 4 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.63%
4/634 • Number of events 4 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.63%
4/634 • Number of events 5 • 24 months
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.63%
4/634 • Number of events 4 • 24 months
|
|
Vascular disorders
Arterial stenosis
|
0.63%
4/634 • Number of events 5 • 24 months
|
|
Vascular disorders
Haemorrhage
|
0.63%
4/634 • Number of events 4 • 24 months
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.47%
3/634 • Number of events 3 • 24 months
|
|
Cardiac disorders
Arrhythmia
|
0.47%
3/634 • Number of events 3 • 24 months
|
|
Cardiac disorders
Atrial tachycardia
|
0.47%
3/634 • Number of events 3 • 24 months
|
|
Cardiac disorders
Cardiac perforation
|
0.47%
3/634 • Number of events 3 • 24 months
|
|
Cardiac disorders
Intracardiac thrombus
|
0.47%
3/634 • Number of events 3 • 24 months
|
|
Cardiac disorders
Pulseless electrical activity
|
0.47%
3/634 • Number of events 3 • 24 months
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.47%
3/634 • Number of events 3 • 24 months
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.47%
3/634 • Number of events 3 • 24 months
|
|
Gastrointestinal disorders
Abdominal pain
|
0.47%
3/634 • Number of events 4 • 24 months
|
|
Gastrointestinal disorders
Diarrhoea
|
0.47%
3/634 • Number of events 3 • 24 months
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.47%
3/634 • Number of events 3 • 24 months
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.47%
3/634 • Number of events 3 • 24 months
|
|
Gastrointestinal disorders
Gastrointestinal ischaemia
|
0.47%
3/634 • Number of events 3 • 24 months
|
|
General disorders
Chest pain
|
0.47%
3/634 • Number of events 3 • 24 months
|
|
General disorders
Dysplasia
|
0.47%
3/634 • Number of events 3 • 24 months
|
|
General disorders
Oedema
|
0.47%
3/634 • Number of events 4 • 24 months
|
|
Immune system disorders
Adverse drug reaction
|
0.47%
3/634 • Number of events 3 • 24 months
|
|
Infections and infestations
Bronchitis
|
0.47%
3/634 • Number of events 3 • 24 months
|
|
Infections and infestations
Community acquired pneumonia
|
0.47%
3/634 • Number of events 3 • 24 months
|
|
Infections and infestations
Endocarditis
|
0.47%
3/634 • Number of events 3 • 24 months
|
|
Infections and infestations
Endocarditis viral
|
0.47%
3/634 • Number of events 3 • 24 months
|
|
Infections and infestations
Febrile infection
|
0.47%
3/634 • Number of events 3 • 24 months
|
|
Infections and infestations
Gastroenteritis
|
0.47%
3/634 • Number of events 4 • 24 months
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.47%
3/634 • Number of events 3 • 24 months
|
|
Infections and infestations
Influenza
|
0.47%
3/634 • Number of events 3 • 24 months
|
|
Injury, poisoning and procedural complications
Cardiac valve replacement complication
|
0.47%
3/634 • Number of events 3 • 24 months
|
|
Injury, poisoning and procedural complications
Vascular access site complication
|
0.47%
3/634 • Number of events 3 • 24 months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.47%
3/634 • Number of events 4 • 24 months
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.47%
3/634 • Number of events 3 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.47%
3/634 • Number of events 3 • 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.47%
3/634 • Number of events 3 • 24 months
|
|
Nervous system disorders
Lethargy
|
0.47%
3/634 • Number of events 3 • 24 months
|
|
Psychiatric disorders
Delirium
|
0.47%
3/634 • Number of events 3 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.47%
3/634 • Number of events 3 • 24 months
|
|
Vascular disorders
Embolism arterial
|
0.47%
3/634 • Number of events 3 • 24 months
|
|
Vascular disorders
Vascular dissection
|
0.47%
3/634 • Number of events 3 • 24 months
|
|
Cardiac disorders
Bifascicular block
|
0.32%
2/634 • Number of events 2 • 24 months
|
|
Cardiac disorders
Palpitations
|
0.32%
2/634 • Number of events 3 • 24 months
|
|
Cardiac disorders
Systolic dysfunction
|
0.32%
2/634 • Number of events 2 • 24 months
|
|
Ear and labyrinth disorders
Vertigo
|
0.32%
2/634 • Number of events 2 • 24 months
|
|
Gastrointestinal disorders
Bilateral inguinal hernia
|
0.32%
2/634 • Number of events 2 • 24 months
|
|
Gastrointestinal disorders
Gastrointestinal obstruction
|
0.32%
2/634 • Number of events 2 • 24 months
|
|
Gastrointestinal disorders
Nausea
|
0.32%
2/634 • Number of events 2 • 24 months
|
|
Gastrointestinal disorders
Oesophagitis
|
0.32%
2/634 • Number of events 2 • 24 months
|
|
Gastrointestinal disorders
Rectal polyp
|
0.32%
2/634 • Number of events 2 • 24 months
|
|
General disorders
Ulcer
|
0.32%
2/634 • Number of events 2 • 24 months
|
|
General disorders
Unknown cause of death
|
0.32%
2/634 • Number of events 2 • 24 months
|
|
Hepatobiliary disorders
Bile duct stone
|
0.32%
2/634 • Number of events 2 • 24 months
|
|
Infections and infestations
Infective exacerbation of bronchiectasis
|
0.32%
2/634 • Number of events 2 • 24 months
|
|
Infections and infestations
Viral infection
|
0.32%
2/634 • Number of events 2 • 24 months
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.32%
2/634 • Number of events 2 • 24 months
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.32%
2/634 • Number of events 2 • 24 months
|
|
Injury, poisoning and procedural complications
Traumatic haemothorax
|
0.32%
2/634 • Number of events 2 • 24 months
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.32%
2/634 • Number of events 3 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.32%
2/634 • Number of events 2 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Mobility decreased
|
0.32%
2/634 • Number of events 2 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.32%
2/634 • Number of events 2 • 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.32%
2/634 • Number of events 2 • 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.32%
2/634 • Number of events 2 • 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.32%
2/634 • Number of events 2 • 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.32%
2/634 • Number of events 2 • 24 months
|
|
Nervous system disorders
Altered state of consciousness
|
0.32%
2/634 • Number of events 2 • 24 months
|
|
Nervous system disorders
Carotid artery stenosis
|
0.32%
2/634 • Number of events 2 • 24 months
|
|
Nervous system disorders
Neuritis
|
0.32%
2/634 • Number of events 2 • 24 months
|
|
Nervous system disorders
Seizure
|
0.32%
2/634 • Number of events 2 • 24 months
|
|
Renal and urinary disorders
Renal impairment
|
0.32%
2/634 • Number of events 2 • 24 months
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.32%
2/634 • Number of events 2 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.32%
2/634 • Number of events 2 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.32%
2/634 • Number of events 2 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.32%
2/634 • Number of events 3 • 24 months
|
|
Vascular disorders
Artery dissection
|
0.32%
2/634 • Number of events 2 • 24 months
|
|
Vascular disorders
Femoral artery perforation
|
0.32%
2/634 • Number of events 2 • 24 months
|
|
Vascular disorders
Ischaemia
|
0.32%
2/634 • Number of events 2 • 24 months
|
|
Vascular disorders
Vascular occlusion
|
0.32%
2/634 • Number of events 2 • 24 months
|
|
Vascular disorders
Intracardiac thrombus
|
0.32%
2/634 • Number of events 2 • 24 months
|
|
Blood and lymphatic system disorders
Anaemia of chronic disease
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Blood and lymphatic system disorders
Anaemia postoperative
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Blood and lymphatic system disorders
Normochromic normocytic anaemia
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Cardiac disorders
Acute coronary syndrome
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Cardiac disorders
Atrioventricular dissociation
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Cardiac disorders
Aystole
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Cardiac disorders
Bradyarrhythmia
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Cardiac disorders
Diastolic dysfunction
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Cardiac disorders
Left ventricular enlargement
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Cardiac disorders
Mitral valve disease
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Cardiac disorders
Tachyarrhythmia
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Cardiac disorders
Trifascicular block
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Cardiac disorders
Ventricular septal defect acquired
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Product Issues
Product issues
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Endocrine disorders
Adrenal mass
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Endocrine disorders
Diabetes mellitus inadequate control
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Eye disorders
Retinal artery occlusion
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Eye disorders
Swollen tear duct
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Gastrointestinal disorders
Constipation
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Gastrointestinal disorders
Gastritis
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Gastrointestinal disorders
Gastritis haemorrhagic
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Gastrointestinal disorders
Intra-abdominal haemorrhage
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Gastrointestinal disorders
Pancreatitis
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Gastrointestinal disorders
Volvulus of small bowel
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
General disorders
Adverse drug reaction
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
General disorders
Chest discomfort
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
General disorders
Chills
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
General disorders
Complication of device insertion
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
General disorders
Crepitations
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
General disorders
Device embolisation
|
0.16%
1/634 • Number of events 2 • 24 months
|
|
General disorders
Fever of unknown origin
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
General disorders
General system disorders
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
General disorders
Ischaemic ulcer
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
General disorders
Necrosis
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
General disorders
Perforation
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
General disorders
Puncture site haemorrhage
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Hepatobiliary disorders
Cholecystitis
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Hepatobiliary disorders
Hepatic failure
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Hepatobiliary disorders
Ischaemic hepatitis
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Infections and infestations
Abscess
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Infections and infestations
Bacterial sepsis
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Infections and infestations
Brain abscess
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Infections and infestations
Bronchopneumonia
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Infections and infestations
Clostridium difficile colitis
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Infections and infestations
Endophthalmitis
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Infections and infestations
Enterococcal infection
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Infections and infestations
Escherichia bacteraemia
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Infections and infestations
Gastroenteritis viral
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Infections and infestations
Labyrinthitis
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Infections and infestations
Osteomyelitis
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Infections and infestations
Respiratory tract infection
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Infections and infestations
Septic arthritis streptococcal
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Infections and infestations
Sinusitis fungal
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Infections and infestations
Staphylococcal infection
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Infections and infestations
Staphylococcal sepsis
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Infections and infestations
Streptococcal infection
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Infections and infestations
Streptococcal sepsis
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Infections and infestations
Wound infection
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Injury, poisoning and procedural complications
Burns third degree
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Injury, poisoning and procedural complications
Cystitis radiation
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Injury, poisoning and procedural complications
Fracture
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Injury, poisoning and procedural complications
Fractured sacrum
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Injury, poisoning and procedural complications
Incarcerated incisional hernia
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Injury, poisoning and procedural complications
Incision site haemorrhage
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Injury, poisoning and procedural complications
Lumbar vertibral fracture L2
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Injury, poisoning and procedural complications
Oesophageal mucosal tear
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Injury, poisoning and procedural complications
Overdose
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Injury, poisoning and procedural complications
Periprocedural myocardial infarction
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Injury, poisoning and procedural complications
Postoperative respiratory distress
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Injury, poisoning and procedural complications
Procedural haemorrhage
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Injury, poisoning and procedural complications
Scrotal haematoma
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Injury, poisoning and procedural complications
Seroma
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Injury, poisoning and procedural complications
Transurethral resection syndrome
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Injury, poisoning and procedural complications
Vascular access site dissection
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.16%
1/634 • Number of events 2 • 24 months
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Investigations
Colonoscopy
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Investigations
Creatinine increased
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Investigations
False positive investigation result
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Investigations
International normalised ratio increased
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Investigations
Oxygen saturation decreased
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Investigations
White blood cell analysis abnormal
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Metabolism and nutrition disorders
Magnesium deficiency
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix cancer metastatic
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myelomonocytic leukaemia
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endocrine neoplasm
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal tract adenoma
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer metastatic
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mesothelioma
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma stage IV
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal cancer metastatic
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer metastatic
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma recurrent
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Nervous system disorders
Brain injury
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Nervous system disorders
Brain stem embolism
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Nervous system disorders
Cerebral arteriosclerosis
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Nervous system disorders
Cluster headache
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Nervous system disorders
Dementia
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Nervous system disorders
Dementia Alzheimer's type
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Nervous system disorders
Encephalopathy
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Nervous system disorders
Headache
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Nervous system disorders
Hemiplegia
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Nervous system disorders
Hypoxic-ischaemic encephalopathy
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Nervous system disorders
Parkinson's disease
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Nervous system disorders
Pneumonia
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Nervous system disorders
Restless legs syndrome
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Nervous system disorders
Subdural hygroma
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Nervous system disorders
Vascular dementia
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Product Issues
Device failure
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Product Issues
Device pacing issue
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Psychiatric disorders
Delusion
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Psychiatric disorders
Hallucination
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Psychiatric disorders
Psychogenic seizure
|
0.16%
1/634 • Number of events 2 • 24 months
|
|
Psychiatric disorders
Social avoidant behaviour
|
0.16%
1/634 • Number of events 2 • 24 months
|
|
Renal and urinary disorders
Acute kidney injury
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Renal and urinary disorders
Bladder stenosis
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Renal and urinary disorders
Calculus bladder
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Renal and urinary disorders
Hypotonic urinary bladder
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Renal and urinary disorders
Nephropathy
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Renal and urinary disorders
Renal ischaemia
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Renal and urinary disorders
Renal mass
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Renal and urinary disorders
Uraemia odour
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Reproductive system and breast disorders
Ovarian mass
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Reproductive system and breast disorders
Scrotal oedema
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiolitis obliterans with organising pneumonia
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Lung consolidation
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Skin and subcutaneous tissue disorders
Pyroderma gangrenosum
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Surgical and medical procedures
Bladder neck operation
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Surgical and medical procedures
Cardiac pacemaker battery replacement
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Surgical and medical procedures
Cardiac rehabilitation therapy
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Surgical and medical procedures
Hospitalisation
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Surgical and medical procedures
Joint surgery
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Surgical and medical procedures
Left atrial appendage occlusion
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Surgical and medical procedures
Pacemaker generated rhythm
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Surgical and medical procedures
Peripheral endarterectomy
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Surgical and medical procedures
Rectal prolapse repair
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Vascular disorders
Aortic aneurysm
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Vascular disorders
Aortic dissection
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Vascular disorders
Aortic rupture
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Vascular disorders
Arterial haemorrhage
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Vascular disorders
Basal ganglia haemorrhage
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Vascular disorders
Femoral artery stenosis
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Vascular disorders
Iliac artery rupture
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Vascular disorders
Orthostatic hypotension
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Vascular disorders
Peripheral ischaemia
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Vascular disorders
Raynaud's phenomenon
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Vascular disorders
Subclavian artery perforation
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Vascular disorders
Vascular pseudoaneurysm
|
0.16%
1/634 • Number of events 1 • 24 months
|
|
Vascular disorders
Vascular pseudoaneurysm ruptured
|
0.16%
1/634 • Number of events 1 • 24 months
|
Other adverse events
| Measure |
Medtronic CoreValve® System Implantation
n=634 participants at risk
Patients with symptomatic severe aortic stenosis who have an elevated surgical risk
Medtronic CoreValve® System: The Medtronic CoreValve® System device is designed to replace the native aortic valve without the requirement for open heart surgery and without concomitant surgical removal of the failed native valve in patients with symptomatic severe aortic stenosis who have an elevated surgical risk
|
|---|---|
|
Cardiac disorders
Bundle branch block left
|
51.4%
326/634 • Number of events 334 • 24 months
|
|
Injury, poisoning and procedural complications
Vascular access site haematoma
|
14.5%
92/634 • Number of events 104 • 24 months
|
|
Cardiac disorders
Atrioventricular block
|
12.8%
81/634 • Number of events 87 • 24 months
|
|
Injury, poisoning and procedural complications
Vascular access site haemorrhage
|
9.9%
63/634 • Number of events 69 • 24 months
|
|
Cardiac disorders
Atrial fibrillation
|
8.7%
55/634 • Number of events 57 • 24 months
|
|
Investigations
Haemoglobin decreased
|
7.7%
49/634 • Number of events 51 • 24 months
|
|
General disorders
Pyrexia
|
7.1%
45/634 • Number of events 45 • 24 months
|
|
Vascular disorders
Hypotension
|
6.9%
44/634 • Number of events 44 • 24 months
|
|
Blood and lymphatic system disorders
Anaemia
|
6.5%
41/634 • Number of events 43 • 24 months
|
|
Infections and infestations
Urinary tract infection
|
6.3%
40/634 • Number of events 41 • 24 months
|
|
Vascular disorders
Haematoma
|
6.2%
39/634 • Number of events 41 • 24 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place