Trial Outcomes & Findings for Medtronic CoreValve Evolut R U.S. Clinical Study (NCT NCT02207569)
NCT ID: NCT02207569
Last Updated: 2022-11-02
Results Overview
Percentage of patients that died by any cause at 30 days
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
241 participants
Primary outcome timeframe
Assessed at 30 days post-implantation
Results posted on
2022-11-02
Participant Flow
Participant milestones
| Measure |
CoreValve Evolut R TAVR System
The CoreValve Evolut R System is a transcatheter aortic valve implantation system comprised of the following three components:
1. Evolut R Transcatheter Aortic Valve (TAV)
\>
2. EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath
\>
3. EnVeo R Loading System (LS)
\>
\> CoreValve Evolut R TAVR system
|
|---|---|
|
Implant
STARTED
|
241
|
|
Implant
COMPLETED
|
241
|
|
Implant
NOT COMPLETED
|
0
|
|
1-Month
STARTED
|
241
|
|
1-Month
COMPLETED
|
232
|
|
1-Month
NOT COMPLETED
|
9
|
|
6-Month
STARTED
|
232
|
|
6-Month
COMPLETED
|
222
|
|
6-Month
NOT COMPLETED
|
10
|
|
12-Month
STARTED
|
213
|
|
12-Month
COMPLETED
|
197
|
|
12-Month
NOT COMPLETED
|
16
|
|
24-Month
STARTED
|
197
|
|
24-Month
COMPLETED
|
171
|
|
24-Month
NOT COMPLETED
|
26
|
|
36-Month
STARTED
|
171
|
|
36-Month
COMPLETED
|
144
|
|
36-Month
NOT COMPLETED
|
27
|
|
48-Month
STARTED
|
144
|
|
48-Month
COMPLETED
|
113
|
|
48-Month
NOT COMPLETED
|
31
|
|
60-Month
STARTED
|
113
|
|
60-Month
COMPLETED
|
109
|
|
60-Month
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
CoreValve Evolut R TAVR System
The CoreValve Evolut R System is a transcatheter aortic valve implantation system comprised of the following three components:
1. Evolut R Transcatheter Aortic Valve (TAV)
\>
2. EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath
\>
3. EnVeo R Loading System (LS)
\>
\> CoreValve Evolut R TAVR system
|
|---|---|
|
1-Month
Death
|
6
|
|
1-Month
Withdrawal by Subject
|
2
|
|
1-Month
Subject anesthetized but product not onsite, for medical justification treated w/commercial device
|
1
|
|
6-Month
Death
|
8
|
|
6-Month
Withdrawal by Subject
|
2
|
|
12-Month
Death
|
14
|
|
12-Month
Withdrawal by Subject
|
2
|
|
24-Month
Death
|
23
|
|
24-Month
Withdrawal by Subject
|
3
|
|
36-Month
Death
|
23
|
|
36-Month
Withdrawal by Subject
|
4
|
|
48-Month
Death
|
25
|
|
48-Month
Withdrawal by Subject
|
2
|
|
48-Month
Lost to Follow-up
|
4
|
|
60-Month
Death
|
1
|
|
60-Month
Lost to Follow-up
|
1
|
|
60-Month
pt 103 years old no longer traveling for MD visits
|
1
|
|
60-Month
Covid-19 pt not willing to be seen
|
1
|
Baseline Characteristics
Medtronic CoreValve Evolut R U.S. Clinical Study
Baseline characteristics by cohort
| Measure |
CoreValve Evolut R TAVR System
n=241 Participants
The CoreValve Evolut R System is a transcatheter aortic valve implantation system comprised of the following three components:\>
1. Evolut R Transcatheter Aortic Valve (TAV)\>
2. EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath\>
3. EnVeo R Loading System (LS)\> \> CoreValve Evolut R TAVR system
|
|---|---|
|
Age, Continuous
|
83.3 years
STANDARD_DEVIATION 7.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
165 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
76 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
241 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Assessed at 30 days post-implantationPopulation: All subjects who are brought into the procedure room and any of the following have occurred: anesthesia administered, vascular line placed, TEE placed, or any monitoring line placed.
Percentage of patients that died by any cause at 30 days
Outcome measures
| Measure |
CoreValve Evolut R TAVR System
n=241 Participants
The CoreValve Evolut R System is a transcatheter aortic valve implantation system comprised of the following three components:
1. Evolut R Transcatheter Aortic Valve (TAV)
\>
2. EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath
\>
3. EnVeo R Loading System (LS)
\>
\> CoreValve Evolut R TAVR system
|
|---|---|
|
All-cause Mortality at 30 Days by Percent
|
2.5 percentage of partcipants
Interval 1.1 to 5.5
|
PRIMARY outcome
Timeframe: Assessed at 30 days post-implantationPopulation: All subjects who are brought into the procedure room and any of the following have occurred: anesthesia administered, vascular line placed, TEE placed, or any monitoring line placed.
Stroke Diagnostic Criteria: \> Acute episode of focal or global neurological deficit with at least 2 of the following: * change in level of consciousness \> * hemiplegia, hemiparesis * numbness or sensory loss affecting 1 side \> * dysphasia or aphasia * hemianopia * amaurosis fugax \> * other neurological signs or symptoms consistent with stroke 2.) No other readily identifiable non-stroke cause or the clinical presentation, to be determined by or in conjunctions with the designated neurologist 3.) Confirmation of the diagnosis by at least 1 of the following: * Neurological specialist \> * Neuroimaging procedure, or on clincial grounds alone \> Stroke: durations of neural deficit \> 24 h if available neuroimaging documents a new hemofrrhage or infarct; or the neurological deficit results in death Defined by VARC II: \> An mRS (Modified Rankin Score) of 2 or more at 90 days and an increase in at least 1 mRS category from pre-stroke baseline
Outcome measures
| Measure |
CoreValve Evolut R TAVR System
n=241 Participants
The CoreValve Evolut R System is a transcatheter aortic valve implantation system comprised of the following three components:
1. Evolut R Transcatheter Aortic Valve (TAV)
\>
2. EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath
\>
3. EnVeo R Loading System (LS)
\>
\> CoreValve Evolut R TAVR system
|
|---|---|
|
Percentage of Patients With Disabling Stroke at 30 Days
|
3.3 percentage of participants
Interval 1.7 to 6.6
|
PRIMARY outcome
Timeframe: Assessed at 24 hours to seven days post implantationPopulation: All subjects implanted with the Evolut R TAV, defined as the Evolut R TAV is placed in the aortic annulus and completely released from the Enveo catheter delivery system
Percentage of patients with Device Success defined as: * Absence of procedural mortality, AND * Correct positioning of a single Evolut R valve into the proper anatomical location, AND * Absence of patient-prosthesis mismatch, and mean gradient , 20 mm Hg (or peak velocity \< 3m/sec, AND * Absence of moderate or severe prosthetic valve regurgitation
Outcome measures
| Measure |
CoreValve Evolut R TAVR System
n=237 Participants
The CoreValve Evolut R System is a transcatheter aortic valve implantation system comprised of the following three components:
1. Evolut R Transcatheter Aortic Valve (TAV)
\>
2. EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath
\>
3. EnVeo R Loading System (LS)
\>
\> CoreValve Evolut R TAVR system
|
|---|---|
|
Percent Device Success Rate Between 24 and 7 Day
|
69.2 percentage of overall device success
Interval 62.3 to 75.5
|
PRIMARY outcome
Timeframe: Assessed at 24 hours to 7 days post implantationPopulation: Subset includes all subjects who are implanted with the Evolut R TAV, defined as the Evolut R TAV is placed in the aortic annulus and completely released from the Enveo catheter delivery system
Percentage of patience with none, trace or mild total prosthetic regurgitation at early post procedure echo cardiogram (24 hours to 7 days) as evaluated by echo core lab.
Outcome measures
| Measure |
CoreValve Evolut R TAVR System
n=237 Participants
The CoreValve Evolut R System is a transcatheter aortic valve implantation system comprised of the following three components:
1. Evolut R Transcatheter Aortic Valve (TAV)
\>
2. EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath
\>
3. EnVeo R Loading System (LS)
\>
\> CoreValve Evolut R TAVR system
|
|---|---|
|
Percentage of Patients With Less Than Moderate Prosthetic Regurgitation at Early Post Procedure Echocardiogram (24 Hours to 7 Days)
|
96.5 percentage of partcipants
Interval 93.3 to 98.5
|
SECONDARY outcome
Timeframe: Assessed at 30 days post-implantationPopulation: The safety subset includes all subjects who are brought into the procedure room and any of the following have occurred: anesthesia administered, vascular line placed, or any monitoring line placed.
Percentage of patients with any valve dysfunction that requires repeat procedure (e.g. balloon valvuloplasty, TAVI, or surgical AVR), per VARC II definition.
Outcome measures
| Measure |
CoreValve Evolut R TAVR System
n=241 Participants
The CoreValve Evolut R System is a transcatheter aortic valve implantation system comprised of the following three components:
1. Evolut R Transcatheter Aortic Valve (TAV)
\>
2. EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath
\>
3. EnVeo R Loading System (LS)
\>
\> CoreValve Evolut R TAVR system
|
|---|---|
|
Individual Component of VARC II Safety Endpoint: Percentage of People Requiring Valve-related Dysfunction Requiring Repeat Procedure (BAV, TAVI, or SAVR)
|
0.0 percentage of overall patients
Interval 0.0 to 1.6
|
SECONDARY outcome
Timeframe: Assessed at 30 days post-implantationPopulation: All subjects who are brought into the procedure room and any of the following have occurred: anesthesia administered, vascular line placed, TEE placed, or any monitoring line placed.
Angiographic or echocardiographic evidence of a new, partial or complete, obstruction of a coronary ostium, either by the Evolut R prosthesis itself, the native leaflets, calcifications, or dissection, occurring during or after the TAVI procedure.
Outcome measures
| Measure |
CoreValve Evolut R TAVR System
n=241 Participants
The CoreValve Evolut R System is a transcatheter aortic valve implantation system comprised of the following three components:
1. Evolut R Transcatheter Aortic Valve (TAV)
\>
2. EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath
\>
3. EnVeo R Loading System (LS)
\>
\> CoreValve Evolut R TAVR system
|
|---|---|
|
Coronary Artery Obstruction Requiring Intervention.
|
0.4 percentage of participants
Interval 0.1 to 3.0
|
SECONDARY outcome
Timeframe: Assessed at 30 days post-implantationPopulation: All subjects who are brought into the procedure room and any of the following have occurred: anesthesia administered, vascular line placed, TEE placed, or any monitoring line placed.
VARC II composite safety endpoint rate includes percent freedom from the following components: * All-cause mortality * All stroke (disabling and non-disabling) * Life-threatening bleeding * Acute kidney injury: stage 2 or 3 (including renal replacement therapy). * Coronary artery obstruction requiring intervention. * Major vascular complication. * Valve-related dysfunction requiring repeat procedure (BAV, TAVI, or SAVR)
Outcome measures
| Measure |
CoreValve Evolut R TAVR System
n=241 Participants
The CoreValve Evolut R System is a transcatheter aortic valve implantation system comprised of the following three components:
1. Evolut R Transcatheter Aortic Valve (TAV)
\>
2. EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath
\>
3. EnVeo R Loading System (LS)
\>
\> CoreValve Evolut R TAVR system
|
|---|---|
|
Percent VARC II Combined Safety Endpoint at 30 Days
|
14.5 percentage of participants
Interval 10.6 to 19.7
|
SECONDARY outcome
Timeframe: Assessed at 30 days post-implantationPopulation: All subjects who are brought into the procedure room and any of the following have occurred: anesthesia administered, vascular line placed, TEE placed, or any monitoring line placed.
Stage 2 1. Increase in serum creatinine to 200%-299% (2.0%-2.99% increase compared with baseline) OR \> 2. Urine output \<0.5 mL/kg/h for \>12 but \<24 h \> Stage 3 \> 1\) Increase in serum creatinine to ≥300% (\>3 x increase compared with baseline) OR serum creatinine of ≥4.0 mg/dL (≥354 mmol/L) with an acute increase of at least 0.5 mg/dL (44 mmol/L) OR * Urine output \<0.3 ml/kg/h for ≥24 h OR \> * Anuria for ≥12 h
Outcome measures
| Measure |
CoreValve Evolut R TAVR System
n=241 Participants
The CoreValve Evolut R System is a transcatheter aortic valve implantation system comprised of the following three components:
1. Evolut R Transcatheter Aortic Valve (TAV)
\>
2. EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath
\>
3. EnVeo R Loading System (LS)
\>
\> CoreValve Evolut R TAVR system
|
|---|---|
|
Percent of Patients With Acute Kidney Injury: Stage 2 or 3 (Including Renal Replacement Therapy).
|
1.3 percentage of participants
Interval 0.4 to 3.9
|
SECONDARY outcome
Timeframe: Assessed at 30 days post-implantationPopulation: All subjects who are brought into the procedure room and any of the following have occurred: anesthesia administered, vascular line placed, TEE placed, or any monitoring line placed.
1. Fatal bleeding (BARC type 5) OR \> 2. Bleeding in a critical organs, such as intracranial, intraspinal, \> intraocular, or pericardial necessitating pericardiocentesis, or intramuscular with compartment syndrome (BARC type 3b and 3c) OR \> 3. Bleeding causing hypovolemic shock or severe hypotension requiring vasopressors or surgery (BARC type 3b) OR \> 4. Overt source of bleeding with drop in hemoglobin ≥5 g/dL or whole blood or packed red blood cells (RBCs) transfusion ≥4 units\* \> (BARC type 3b)
Outcome measures
| Measure |
CoreValve Evolut R TAVR System
n=241 Participants
The CoreValve Evolut R System is a transcatheter aortic valve implantation system comprised of the following three components:
1. Evolut R Transcatheter Aortic Valve (TAV)
\>
2. EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath
\>
3. EnVeo R Loading System (LS)
\>
\> CoreValve Evolut R TAVR system
|
|---|---|
|
Percentage of Patients With Life-threatening or Disabling Bleeding Event Rate
|
7.1 percentage of participants
Interval 4.4 to 11.2
|
SECONDARY outcome
Timeframe: Assessed at 30 daysPopulation: All subjects who are brought into the procedure room and any of the following have occurred: anesthesia administered, vascular line placed, TEE placed, or any monitoring line placed. Additionally, these patients did NOT have ICD or PPM at the time of the index procedure.
Percent of patients who underwent implantation of new permanent pacemaker or ICD during or after index procedure
Outcome measures
| Measure |
CoreValve Evolut R TAVR System
n=201 Participants
The CoreValve Evolut R System is a transcatheter aortic valve implantation system comprised of the following three components:
1. Evolut R Transcatheter Aortic Valve (TAV)
\>
2. EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath
\>
3. EnVeo R Loading System (LS)
\>
\> CoreValve Evolut R TAVR system
|
|---|---|
|
Percent Rate of Patients Who Received New Permanent Pacemaker Implant at 30 Days
|
19.7 percentage of participants
Interval 14.7 to 26.1
|
SECONDARY outcome
Timeframe: Assessed intra-procedurallyPopulation: 65 patients had resheath or recapture feature used during the 241 attempted procedures.
Resheath or recapture success rate (where attempted) where a successful resheath is defined as the intended portion of the Evolut R is resheathed into the capsule of the delivery catheter to the intended amount, as verified by flouroscopy; and a successful recapture is defined as the entire Evolut R TAV (including the frame) is full resheathed into the capsule of the delivery catheter until there is no gap between the capsule and the tip , as verified by flouroscopy. Resheath or recapture wa attempted in a subset of patients. Success rate is calculated as successful resheath or recaputure events in the number of total events. Resheath anad recapture is only possible during the index procedure.
Outcome measures
| Measure |
CoreValve Evolut R TAVR System
n=65 Participants
The CoreValve Evolut R System is a transcatheter aortic valve implantation system comprised of the following three components:
1. Evolut R Transcatheter Aortic Valve (TAV)
\>
2. EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath
\>
3. EnVeo R Loading System (LS)
\>
\> CoreValve Evolut R TAVR system
|
|---|---|
|
Percent Resheath and Recapture Success Rate
|
96.9 percentage of resheath or recapture
|
SECONDARY outcome
Timeframe: Assessed at baseline, 30 days, 6 months, and 1 yearPopulation: The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the Evolut R system. Only subjects with echo can be analyzed.
Mean gradient by Doppler echocardiography.
Outcome measures
| Measure |
CoreValve Evolut R TAVR System
n=237 Participants
The CoreValve Evolut R System is a transcatheter aortic valve implantation system comprised of the following three components:
1. Evolut R Transcatheter Aortic Valve (TAV)
\>
2. EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath
\>
3. EnVeo R Loading System (LS)
\>
\> CoreValve Evolut R TAVR system
|
|---|---|
|
Hemodynamic Performance -Mean Gradient
baseline
|
48.2 mmHg
Standard Deviation 13.0
|
|
Hemodynamic Performance -Mean Gradient
30 days
|
7.8 mmHg
Standard Deviation 3.1
|
|
Hemodynamic Performance -Mean Gradient
6 months
|
8.4 mmHg
Standard Deviation 3.8
|
|
Hemodynamic Performance -Mean Gradient
1 year
|
9.1 mmHg
Standard Deviation 4.7
|
SECONDARY outcome
Timeframe: Assessed at 30 days post-implantationPopulation: The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the Evolut R system.
1. Any aortic dissection, aortic rupture, annulus rupture, left ventricle perforation, or new apical aneurysm/pseudoaneurysm OR \> 2. Access-related vascular injury (dissection, stenosis, perforation, rupture, arterio-venous fistula, pseudoaneurysm, hematoma, irreversible nerve injury, compartment syndrome, percutaneous closure device failure) leading to death, life-threatening or major bleeding, visceral ischemia, or neurological impairment OR \> 3. Distal embolization (noncerebral) from a vascular source requiring surgery or resulting in amputation or irreversible end-organ damage OR \> 4. The use of unplanned endovascular or surgery associated with death, major bleeding, visceral ischemia or neurological impairment OR \> 5. Any new ipsilateral lower extremity ischemia documented by patient symptoms, physical exam, and/or decreased or absent blood flow on lower extremity angiogram OR \> 6. Surgery for access site nerve injury OR \> 7. Permanent access related nerve injury
Outcome measures
| Measure |
CoreValve Evolut R TAVR System
n=237 Participants
The CoreValve Evolut R System is a transcatheter aortic valve implantation system comprised of the following three components:
1. Evolut R Transcatheter Aortic Valve (TAV)
\>
2. EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath
\>
3. EnVeo R Loading System (LS)
\>
\> CoreValve Evolut R TAVR system
|
|---|---|
|
Major Vascular Complication
|
7.5 percentage of participants
Interval 4.8 to 11.7
|
SECONDARY outcome
Timeframe: Assessed at baseline, 30 days, 6 months, and 1 yearPopulation: The hemodynamic performance subset includes all subjects implanted with the Evolut R TAV for more than 24 hours post implantation - only subjects with echo can be analyzed.
Hemodynamic performance by Doppler echocardiography - Aortic Valve Area cm2
Outcome measures
| Measure |
CoreValve Evolut R TAVR System
n=237 Participants
The CoreValve Evolut R System is a transcatheter aortic valve implantation system comprised of the following three components:
1. Evolut R Transcatheter Aortic Valve (TAV)
\>
2. EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath
\>
3. EnVeo R Loading System (LS)
\>
\> CoreValve Evolut R TAVR system
|
|---|---|
|
Hemodynamic Performance - Aortic Valve Area
baseline
|
0.6 cm²
Standard Deviation 0.2
|
|
Hemodynamic Performance - Aortic Valve Area
30 days
|
1.9 cm²
Standard Deviation 0.5
|
|
Hemodynamic Performance - Aortic Valve Area
6 months
|
1.8 cm²
Standard Deviation 0.5
|
|
Hemodynamic Performance - Aortic Valve Area
1 year
|
1.8 cm²
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: Assessed at 30 days, 6 months, and 1 yearPopulation: The hemodynamic performance subset includes all subjects implanted with the Evolut R TAV for more than 24 hours post implantation. Only subjects with echo can be analyzed.
Hemodynamic performance: the percent of patients who have a degree of total prosthetic valve regurgitation that is moderate or severe.
Outcome measures
| Measure |
CoreValve Evolut R TAVR System
n=237 Participants
The CoreValve Evolut R System is a transcatheter aortic valve implantation system comprised of the following three components:
1. Evolut R Transcatheter Aortic Valve (TAV)
\>
2. EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath
\>
3. EnVeo R Loading System (LS)
\>
\> CoreValve Evolut R TAVR system
|
|---|---|
|
Hemodynamic Performance: Total Prosthetic Valve Regurgitation Graded as Moderate or Severe
30 days
|
5.7 percentage of participants
|
|
Hemodynamic Performance: Total Prosthetic Valve Regurgitation Graded as Moderate or Severe
6 months
|
5.4 percentage of participants
|
|
Hemodynamic Performance: Total Prosthetic Valve Regurgitation Graded as Moderate or Severe
1 year
|
3.7 percentage of participants
|
Adverse Events
CoreValve Evolut R TAVR System
Serious events: 170 serious events
Other events: 197 other events
Deaths: 107 deaths
Serious adverse events
| Measure |
CoreValve Evolut R TAVR System
n=241 participants at risk
The CoreValve Evolut R System is a transcatheter aortic valve implantation system comprised of the following three components:
Evolut R Transcatheter Aortic Valve (TAV) EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath EnVeo R Loading System (LS)
|
|---|---|
|
Vascular disorders
Iliac Vein Occlusion
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Vascular disorders
Intermittent Claudication
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Vascular disorders
Labile Blood Pressure
|
1.2%
3/241 • Number of events 3 • All events - 12 months, All Cause Mortality - 60 months
|
|
Vascular disorders
Labile Hypertension
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Vascular disorders
Malignant Hypertension
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Vascular disorders
Orthostatic Hypotension
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Blood and lymphatic system disorders
Anaemia
|
14.9%
36/241 • Number of events 39 • All events - 12 months, All Cause Mortality - 60 months
|
|
Blood and lymphatic system disorders
Haemolytic Anaemia
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Blood and lymphatic system disorders
Iron Deficiency Anaemia
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Blood and lymphatic system disorders
Splenic Infarction
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.83%
2/241 • Number of events 2 • All events - 12 months, All Cause Mortality - 60 months
|
|
Cardiac disorders
Acute Myocardial Infarction
|
1.2%
3/241 • Number of events 3 • All events - 12 months, All Cause Mortality - 60 months
|
|
Cardiac disorders
Angina Unstable
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Cardiac disorders
Aortic Valve Incompetence
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Cardiac disorders
Atrial Fibrillation
|
6.2%
15/241 • Number of events 16 • All events - 12 months, All Cause Mortality - 60 months
|
|
Cardiac disorders
Atrioventricular Block Complete
|
13.3%
32/241 • Number of events 32 • All events - 12 months, All Cause Mortality - 60 months
|
|
Cardiac disorders
Atrioventricular Block Second Degree
|
1.2%
3/241 • Number of events 3 • All events - 12 months, All Cause Mortality - 60 months
|
|
Cardiac disorders
Bradycardia
|
0.83%
2/241 • Number of events 2 • All events - 12 months, All Cause Mortality - 60 months
|
|
Cardiac disorders
Bundle Branch Block Left
|
1.7%
4/241 • Number of events 4 • All events - 12 months, All Cause Mortality - 60 months
|
|
Cardiac disorders
Bundle Branch Block Right
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Cardiac disorders
Cardiac Arrest
|
1.7%
4/241 • Number of events 4 • All events - 12 months, All Cause Mortality - 60 months
|
|
Cardiac disorders
Cardiac Failure
|
2.5%
6/241 • Number of events 6 • All events - 12 months, All Cause Mortality - 60 months
|
|
Cardiac disorders
Cardiac Failure Acute
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Cardiac disorders
Cardiac Failure Congestive
|
9.1%
22/241 • Number of events 28 • All events - 12 months, All Cause Mortality - 60 months
|
|
Cardiac disorders
Cardiac Perforation
|
1.2%
3/241 • Number of events 3 • All events - 12 months, All Cause Mortality - 60 months
|
|
Cardiac disorders
Cardiogenic Shock
|
0.83%
2/241 • Number of events 2 • All events - 12 months, All Cause Mortality - 60 months
|
|
Cardiac disorders
Coronary Artery Disease
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Cardiac disorders
Intracardiac Thrombus
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Cardiac disorders
Left Ventricular Dysfunction
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Cardiac disorders
Mitral Valve Incompetence
|
1.7%
4/241 • Number of events 4 • All events - 12 months, All Cause Mortality - 60 months
|
|
Cardiac disorders
Myocardial Infarction
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Cardiac disorders
Myocardial Ischaemia
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Cardiac disorders
Nodal Rhythm
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Cardiac disorders
Pericardial Effusion
|
1.2%
3/241 • Number of events 3 • All events - 12 months, All Cause Mortality - 60 months
|
|
Cardiac disorders
Pulseless Electrical Activity
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Cardiac disorders
Right Ventricular Dysfunction
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Cardiac disorders
Right Ventricular Failure
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Cardiac disorders
Sinus Bradycardia
|
1.2%
3/241 • Number of events 3 • All events - 12 months, All Cause Mortality - 60 months
|
|
Cardiac disorders
Sinus Node Dysfunction
|
0.83%
2/241 • Number of events 2 • All events - 12 months, All Cause Mortality - 60 months
|
|
Cardiac disorders
Stress Cardiomyopathy
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Cardiac disorders
Ventricular Asystole
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Cardiac disorders
Ventricular Fibrillation
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Cardiac disorders
Ventricular Tachycardia
|
0.83%
2/241 • Number of events 2 • All events - 12 months, All Cause Mortality - 60 months
|
|
Eye disorders
Cataract
|
0.83%
2/241 • Number of events 2 • All events - 12 months, All Cause Mortality - 60 months
|
|
Eye disorders
Glaucoma
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Eye disorders
Visual Impairment
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Gastrointestinal disorders
Dysphagia
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Gastrointestinal disorders
Gastric Ulcer
|
0.83%
2/241 • Number of events 2 • All events - 12 months, All Cause Mortality - 60 months
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
5.0%
12/241 • Number of events 12 • All events - 12 months, All Cause Mortality - 60 months
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Gastrointestinal disorders
Hiatus Hernia
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Gastrointestinal disorders
Inguinal Hernia
|
1.7%
4/241 • Number of events 4 • All events - 12 months, All Cause Mortality - 60 months
|
|
Gastrointestinal disorders
Intestinal Ischaemia
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Gastrointestinal disorders
Retroperitoneal Haemorrhage
|
1.7%
4/241 • Number of events 5 • All events - 12 months, All Cause Mortality - 60 months
|
|
General disorders
Chest Pain
|
1.2%
3/241 • Number of events 3 • All events - 12 months, All Cause Mortality - 60 months
|
|
General disorders
Death
|
0.83%
2/241 • Number of events 2 • All events - 12 months, All Cause Mortality - 60 months
|
|
General disorders
Device Deployment Issue
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
General disorders
Device Dislocation
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
General disorders
Implant Site Haemorrhage
|
1.2%
3/241 • Number of events 4 • All events - 12 months, All Cause Mortality - 60 months
|
|
General disorders
Implant Site Pain
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
General disorders
Lead Dislodgement
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
General disorders
Oedema Peripheral
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
General disorders
Systemic Inflammatory Response Syndrome
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Hepatobiliary disorders
Cholecystitis
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Hepatobiliary disorders
Gallbladder Disorder
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Infections and infestations
Abdominal Wall Abscess
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Infections and infestations
Acquired Immunodeficiency Syndrome
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Infections and infestations
Bronchitis
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Infections and infestations
Cellulitis
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Infections and infestations
Clostridium Difficile Colitis
|
2.1%
5/241 • Number of events 5 • All events - 12 months, All Cause Mortality - 60 months
|
|
Infections and infestations
Diverticulitis
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Infections and infestations
Diverticulitis Intestinal Haemorrhagic
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Infections and infestations
Gangrene
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Infections and infestations
Incision Site Infection
|
0.83%
2/241 • Number of events 2 • All events - 12 months, All Cause Mortality - 60 months
|
|
Infections and infestations
Influenza
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Infections and infestations
Osteomyelitis
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Infections and infestations
Pneumonia
|
5.0%
12/241 • Number of events 16 • All events - 12 months, All Cause Mortality - 60 months
|
|
Infections and infestations
Pneumonia Staphylococcal
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Infections and infestations
Postoperative Wound Infection
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Infections and infestations
Sepsis
|
3.3%
8/241 • Number of events 8 • All events - 12 months, All Cause Mortality - 60 months
|
|
Infections and infestations
Septic Shock
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.83%
2/241 • Number of events 2 • All events - 12 months, All Cause Mortality - 60 months
|
|
Infections and infestations
Urinary Tract Infection
|
3.7%
9/241 • Number of events 9 • All events - 12 months, All Cause Mortality - 60 months
|
|
Infections and infestations
Urosepsis
|
0.41%
1/241 • Number of events 2 • All events - 12 months, All Cause Mortality - 60 months
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Injury, poisoning and procedural complications
Arterial Injury
|
0.83%
2/241 • Number of events 2 • All events - 12 months, All Cause Mortality - 60 months
|
|
Injury, poisoning and procedural complications
Compression Fracture
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Injury, poisoning and procedural complications
Feeding Tube Complication
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
1.2%
3/241 • Number of events 3 • All events - 12 months, All Cause Mortality - 60 months
|
|
Injury, poisoning and procedural complications
Incision Site Complication
|
1.7%
4/241 • Number of events 4 • All events - 12 months, All Cause Mortality - 60 months
|
|
Injury, poisoning and procedural complications
Incision Site Haematoma
|
2.5%
6/241 • Number of events 7 • All events - 12 months, All Cause Mortality - 60 months
|
|
Injury, poisoning and procedural complications
Incision Site Haemorrhage
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Injury, poisoning and procedural complications
Laceration
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Injury, poisoning and procedural complications
Pelvic Fracture
|
0.83%
2/241 • Number of events 2 • All events - 12 months, All Cause Mortality - 60 months
|
|
Injury, poisoning and procedural complications
Seroma
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Injury, poisoning and procedural complications
Subdural Haematoma
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Injury, poisoning and procedural complications
Vascular Pseudoaneurysm
|
0.83%
2/241 • Number of events 2 • All events - 12 months, All Cause Mortality - 60 months
|
|
Investigations
Blood Magnesium Decreased
|
0.83%
2/241 • Number of events 2 • All events - 12 months, All Cause Mortality - 60 months
|
|
Investigations
Blood Pressure Increased
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Investigations
International Normalised Ratio Increased
|
0.83%
2/241 • Number of events 2 • All events - 12 months, All Cause Mortality - 60 months
|
|
Investigations
Urine Output Decreased
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Metabolism and nutrition disorders
Fluid Overload
|
0.83%
2/241 • Number of events 2 • All events - 12 months, All Cause Mortality - 60 months
|
|
Metabolism and nutrition disorders
Gout
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.83%
2/241 • Number of events 2 • All events - 12 months, All Cause Mortality - 60 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.2%
3/241 • Number of events 3 • All events - 12 months, All Cause Mortality - 60 months
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Metabolism and nutrition disorders
Lactic Acidosis
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Metabolism and nutrition disorders
Metabolic Acidosis
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Musculoskeletal and connective tissue disorders
Rotator Cuff Syndrome
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Musculoskeletal and connective tissue disorders
Spinal Column Stenosis
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Cancer
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chondrosarcoma
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Neoplasm
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small Intestine Adenocarcinoma
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma
|
0.83%
2/241 • Number of events 2 • All events - 12 months, All Cause Mortality - 60 months
|
|
Nervous system disorders
Brain Injury
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Nervous system disorders
Carotid Artery Stenosis
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Nervous system disorders
Cerebral Haemorrhage
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Nervous system disorders
Cerebral Infarction
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Nervous system disorders
Cerebrovascular Accident
|
4.1%
10/241 • Number of events 12 • All events - 12 months, All Cause Mortality - 60 months
|
|
Nervous system disorders
Dizziness
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Nervous system disorders
Encephalopathy
|
0.83%
2/241 • Number of events 2 • All events - 12 months, All Cause Mortality - 60 months
|
|
Nervous system disorders
Hemiplegia
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Nervous system disorders
Hypoxic-Ischaemic Encephalopathy
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Nervous system disorders
Ischaemic Stroke
|
1.2%
3/241 • Number of events 3 • All events - 12 months, All Cause Mortality - 60 months
|
|
Nervous system disorders
Metabolic Encephalopathy
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Nervous system disorders
Partial Seizures
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Nervous system disorders
Speech Disorder
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Nervous system disorders
Syncope
|
0.83%
2/241 • Number of events 2 • All events - 12 months, All Cause Mortality - 60 months
|
|
Nervous system disorders
Thalamic Infarction
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Nervous system disorders
Transient Ischaemic Attack
|
1.7%
4/241 • Number of events 5 • All events - 12 months, All Cause Mortality - 60 months
|
|
Psychiatric disorders
Delirium
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Psychiatric disorders
Hallucination, Visual
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Psychiatric disorders
Mental Disorder
|
1.7%
4/241 • Number of events 4 • All events - 12 months, All Cause Mortality - 60 months
|
|
Renal and urinary disorders
Acute Kidney Injury
|
2.1%
5/241 • Number of events 6 • All events - 12 months, All Cause Mortality - 60 months
|
|
Renal and urinary disorders
Haematuria
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Renal and urinary disorders
Renal Failure
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Renal and urinary disorders
Renal Infarct
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Renal and urinary disorders
Urinary Retention
|
0.83%
2/241 • Number of events 3 • All events - 12 months, All Cause Mortality - 60 months
|
|
Reproductive system and breast disorders
Benign Prostatic Hyperplasia
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute Pulmonary Oedema
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
3.3%
8/241 • Number of events 11 • All events - 12 months, All Cause Mortality - 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.83%
2/241 • Number of events 2 • All events - 12 months, All Cause Mortality - 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.83%
2/241 • Number of events 2 • All events - 12 months, All Cause Mortality - 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
1.7%
4/241 • Number of events 6 • All events - 12 months, All Cause Mortality - 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia Aspiration
|
0.41%
1/241 • Number of events 2 • All events - 12 months, All Cause Mortality - 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Hypertension
|
0.83%
2/241 • Number of events 2 • All events - 12 months, All Cause Mortality - 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
2.1%
5/241 • Number of events 5 • All events - 12 months, All Cause Mortality - 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Depression
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
5.4%
13/241 • Number of events 14 • All events - 12 months, All Cause Mortality - 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Skin and subcutaneous tissue disorders
Diabetic Ulcer
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Skin and subcutaneous tissue disorders
Skin Ulcer
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Skin and subcutaneous tissue disorders
Subacute Cutaneous Lupus Erythematosus
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Surgical and medical procedures
Hospitalisation
|
0.41%
1/241 • Number of events 18 • All events - 12 months, All Cause Mortality - 60 months
|
|
Vascular disorders
Aortic Dissection
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Vascular disorders
Aortic Dissection Rupture
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Vascular disorders
Arteriosclerosis
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.83%
2/241 • Number of events 2 • All events - 12 months, All Cause Mortality - 60 months
|
|
Vascular disorders
Femoral Artery Dissection
|
0.83%
2/241 • Number of events 2 • All events - 12 months, All Cause Mortality - 60 months
|
|
Vascular disorders
Femoral Artery Occlusion
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Vascular disorders
Haematoma
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Vascular disorders
Haemorrhage
|
0.41%
1/241 • Number of events 2 • All events - 12 months, All Cause Mortality - 60 months
|
|
Vascular disorders
Hypertension
|
3.7%
9/241 • Number of events 9 • All events - 12 months, All Cause Mortality - 60 months
|
|
Vascular disorders
Hypotension
|
6.6%
16/241 • Number of events 16 • All events - 12 months, All Cause Mortality - 60 months
|
|
Vascular disorders
Peripheral Arterial Occlusive Disease
|
0.83%
2/241 • Number of events 2 • All events - 12 months, All Cause Mortality - 60 months
|
|
Vascular disorders
Peripheral Artery Dissection
|
0.41%
1/241 • Number of events 1 • All events - 12 months, All Cause Mortality - 60 months
|
|
Vascular disorders
Peripheral Artery Stenosis
|
0.83%
2/241 • Number of events 2 • All events - 12 months, All Cause Mortality - 60 months
|
|
Vascular disorders
Peripheral Ischaemia
|
1.2%
3/241 • Number of events 3 • All events - 12 months, All Cause Mortality - 60 months
|
|
Vascular disorders
Peripheral Vascular Disorder
|
0.83%
2/241 • Number of events 2 • All events - 12 months, All Cause Mortality - 60 months
|
Other adverse events
| Measure |
CoreValve Evolut R TAVR System
n=241 participants at risk
The CoreValve Evolut R System is a transcatheter aortic valve implantation system comprised of the following three components:
Evolut R Transcatheter Aortic Valve (TAV) EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath EnVeo R Loading System (LS)
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
19.9%
48/241 • Number of events 49 • All events - 12 months, All Cause Mortality - 60 months
|
|
Blood and lymphatic system disorders
Leukocytosis
|
7.9%
19/241 • Number of events 19 • All events - 12 months, All Cause Mortality - 60 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
15.4%
37/241 • Number of events 37 • All events - 12 months, All Cause Mortality - 60 months
|
|
Cardiac disorders
Atrial Fibrillation
|
7.9%
19/241 • Number of events 21 • All events - 12 months, All Cause Mortality - 60 months
|
|
Cardiac disorders
Atrioventricular Block First Degree
|
16.2%
39/241 • Number of events 40 • All events - 12 months, All Cause Mortality - 60 months
|
|
Cardiac disorders
Bundle Branch Block Left
|
32.8%
79/241 • Number of events 82 • All events - 12 months, All Cause Mortality - 60 months
|
|
Cardiac disorders
Bundle Branch Block Right
|
5.4%
13/241 • Number of events 13 • All events - 12 months, All Cause Mortality - 60 months
|
|
Cardiac disorders
Cardiac Failure Congestive
|
6.6%
16/241 • Number of events 17 • All events - 12 months, All Cause Mortality - 60 months
|
|
Cardiac disorders
Ventricular Extrasystoles
|
5.4%
13/241 • Number of events 13 • All events - 12 months, All Cause Mortality - 60 months
|
|
General disorders
Chest Pain
|
5.4%
13/241 • Number of events 14 • All events - 12 months, All Cause Mortality - 60 months
|
|
Infections and infestations
Urinary Tract Infection
|
13.3%
32/241 • Number of events 38 • All events - 12 months, All Cause Mortality - 60 months
|
|
Injury, poisoning and procedural complications
Fall
|
7.5%
18/241 • Number of events 25 • All events - 12 months, All Cause Mortality - 60 months
|
|
Injury, poisoning and procedural complications
Incision Site Haematoma
|
6.6%
16/241 • Number of events 18 • All events - 12 months, All Cause Mortality - 60 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
8.3%
20/241 • Number of events 20 • All events - 12 months, All Cause Mortality - 60 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
5.8%
14/241 • Number of events 16 • All events - 12 months, All Cause Mortality - 60 months
|
|
Renal and urinary disorders
Acute Kidney Injury
|
7.1%
17/241 • Number of events 17 • All events - 12 months, All Cause Mortality - 60 months
|
|
Renal and urinary disorders
Renal Failure
|
5.4%
13/241 • Number of events 13 • All events - 12 months, All Cause Mortality - 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.8%
14/241 • Number of events 14 • All events - 12 months, All Cause Mortality - 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
11.2%
27/241 • Number of events 29 • All events - 12 months, All Cause Mortality - 60 months
|
|
Vascular disorders
Hypertension
|
16.6%
40/241 • Number of events 44 • All events - 12 months, All Cause Mortality - 60 months
|
|
Vascular disorders
Hypotension
|
8.3%
20/241 • Number of events 21 • All events - 12 months, All Cause Mortality - 60 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place