Trial Outcomes & Findings for Portico Next Generation Approval Study (NCT NCT04011722)
NCT ID: NCT04011722
Last Updated: 2025-07-31
Results Overview
All-cause mortality is defined as the total number of deaths in each cohort at 30 days.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
NA
Target enrollment
333 participants
Primary outcome timeframe
at 30 days
Results posted on
2025-07-31
Participant Flow
Participant milestones
| Measure |
Portico™ NG (Navitor) Valve, FlexNav™ Delivery System
Portico ™ NG (Navitor) valve implantation with the new generation Portico NG (Navitor) valve (23mm, 25mm, 27mm and 29mm sizes), and the second-generation FlexNav Delivery system (small and large), Portico™ NG (Navitor) Loading System(s) (small and large).
Portico™ NG (Navitor) Valve and FlexNav™ Delivery System: Subjects will undergo transcatheter aortic valve implantation (TAVI) with the new generation Portico NG (Navitor) valve and second-generation FlexNav Delivery system via a transfemoral or alternative access approach according to the site's anesthesia protocol for TAVR procedures.
|
Navitor Titan Valve
Navitor Titan Valve (35mm) implantation with the large FlexNav Delivery system and Navitor Loading System - LG+.
Navitor Titan Valve (35mm) Valve and Large FlexNav™ Delivery System: Subjects will undergo transcatheter aortic valve implantation (TAVI) with the Navitor Titan valve and large FlexNav Delivery system via a transfemoral or alternative access approach according to the site's anesthesia protocol for TAVR procedures.
|
|---|---|---|
|
Baseline
STARTED
|
260
|
73
|
|
Baseline
COMPLETED
|
260
|
73
|
|
Baseline
NOT COMPLETED
|
0
|
0
|
|
Procedure
STARTED
|
260
|
73
|
|
Procedure
COMPLETED
|
260
|
73
|
|
Procedure
NOT COMPLETED
|
0
|
0
|
|
Discharge
STARTED
|
260
|
73
|
|
Discharge
COMPLETED
|
260
|
73
|
|
Discharge
NOT COMPLETED
|
0
|
0
|
|
30 Days
STARTED
|
260
|
73
|
|
30 Days
COMPLETED
|
255
|
72
|
|
30 Days
NOT COMPLETED
|
5
|
1
|
|
1 Year
STARTED
|
255
|
72
|
|
1 Year
COMPLETED
|
228
|
44
|
|
1 Year
NOT COMPLETED
|
27
|
28
|
|
2 Year
STARTED
|
234
|
64
|
|
2 Year
COMPLETED
|
155
|
5
|
|
2 Year
NOT COMPLETED
|
79
|
59
|
|
3 Year
STARTED
|
208
|
0
|
|
3 Year
COMPLETED
|
61
|
0
|
|
3 Year
NOT COMPLETED
|
147
|
0
|
Reasons for withdrawal
| Measure |
Portico™ NG (Navitor) Valve, FlexNav™ Delivery System
Portico ™ NG (Navitor) valve implantation with the new generation Portico NG (Navitor) valve (23mm, 25mm, 27mm and 29mm sizes), and the second-generation FlexNav Delivery system (small and large), Portico™ NG (Navitor) Loading System(s) (small and large).
Portico™ NG (Navitor) Valve and FlexNav™ Delivery System: Subjects will undergo transcatheter aortic valve implantation (TAVI) with the new generation Portico NG (Navitor) valve and second-generation FlexNav Delivery system via a transfemoral or alternative access approach according to the site's anesthesia protocol for TAVR procedures.
|
Navitor Titan Valve
Navitor Titan Valve (35mm) implantation with the large FlexNav Delivery system and Navitor Loading System - LG+.
Navitor Titan Valve (35mm) Valve and Large FlexNav™ Delivery System: Subjects will undergo transcatheter aortic valve implantation (TAVI) with the Navitor Titan valve and large FlexNav Delivery system via a transfemoral or alternative access approach according to the site's anesthesia protocol for TAVR procedures.
|
|---|---|---|
|
30 Days
Death
|
5
|
1
|
|
1 Year
Death
|
13
|
5
|
|
1 Year
Withdrawal by Subject
|
8
|
2
|
|
1 Year
Missed Visit
|
6
|
1
|
|
1 Year
Pending Visit
|
0
|
11
|
|
1 Year
Not Yet Due
|
0
|
9
|
|
2 Year
Death
|
16
|
1
|
|
2 Year
Withdrawal by Subject
|
10
|
1
|
|
2 Year
Missed Visit
|
9
|
0
|
|
2 Year
Visit Pending
|
1
|
3
|
|
2 Year
Not Yet Due
|
43
|
54
|
|
3 Year
Death
|
10
|
0
|
|
3 Year
Withdrawal by Subject
|
2
|
0
|
|
3 Year
Missed Visit
|
2
|
0
|
|
3 Year
Pending Visit
|
34
|
0
|
|
3 Year
Not Yet Due
|
99
|
0
|
Baseline Characteristics
Portico Next Generation Approval Study
Baseline characteristics by cohort
| Measure |
Portico™ NG (Navitor) Valve, FlexNav™ Delivery System
n=260 Participants
Portico ™ NG (Navitor) valve implantation with the new generation Portico NG (Navitor) valve (23mm, 25mm, 27mm and 29mm sizes), and the second-generation FlexNav Delivery system (small and large), Portico™ NG (Navitor) Loading System(s) (small and large).
Portico™ NG (Navitor) Valve and FlexNav™ Delivery System: Subjects will undergo transcatheter aortic valve implantation (TAVI) with the new generation Portico NG (Navitor) valve and second-generation FlexNav Delivery system via a transfemoral or alternative access approach according to the site's anesthesia protocol for TAVR procedures.
|
Navitor Titan Valve
n=73 Participants
Navitor Titan Valve (35mm) implantation with the large FlexNav Delivery system and Navitor Loading System - LG+.
Navitor Titan Valve (35mm) Valve and Large FlexNav™ Delivery System: Subjects will undergo transcatheter aortic valve implantation (TAVI) with the Navitor Titan valve and large FlexNav Delivery system via a transfemoral or alternative access approach according to the site's anesthesia protocol for TAVR procedures.
|
Total
n=333 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
83.4 Years
STANDARD_DEVIATION 5.4 • n=5 Participants
|
80.6 Years
STANDARD_DEVIATION 5.2 • n=7 Participants
|
82.0 Years
STANDARD_DEVIATION 5.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
149 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
150 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
111 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
183 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
257 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
328 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
189 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
245 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
64 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
NYHA Class
NYHA I
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
NYHA Class
NYHA II
|
117 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
170 Participants
n=5 Participants
|
|
NYHA Class
NYHA III
|
138 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
157 Participants
n=5 Participants
|
|
NYHA Class
NYHA IV
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
STS Risk of Mortality
|
3.9 Percentage of Risk
STANDARD_DEVIATION 2.1 • n=5 Participants
|
2.7 Percentage of Risk
STANDARD_DEVIATION 1.3 • n=7 Participants
|
3.3 Percentage of Risk
STANDARD_DEVIATION 1.7 • n=5 Participants
|
|
EuroSCORE II
|
3.4 Percentage of Risk
STANDARD_DEVIATION 2.3 • n=5 Participants
|
2.7 Percentage of Risk
STANDARD_DEVIATION 1.7 • n=7 Participants
|
3.05 Percentage of Risk
STANDARD_DEVIATION 2.0 • n=5 Participants
|
PRIMARY outcome
Timeframe: at 30 daysAll-cause mortality is defined as the total number of deaths in each cohort at 30 days.
Outcome measures
| Measure |
Portico™ NG (Navitor) Valve, FlexNav™ Delivery System
n=260 Participants
Portico ™ NG (Navitor) valve implantation with the new generation Portico NG (Navitor) valve (23mm, 25mm, 27mm and 29mm sizes), and the second-generation FlexNav Delivery system (small and large), Portico™ NG (Navitor) Loading System(s) (small and large).
Portico™ NG (Navitor) Valve and FlexNav™ Delivery System: Subjects will undergo transcatheter aortic valve implantation (TAVI) with the new generation Portico NG (Navitor) valve and second-generation FlexNav Delivery system via a transfemoral or alternative access approach according to the site's anesthesia protocol for TAVR procedures.
|
Navitor Titan Valve
n=73 Participants
Navitor Titan Valve (35mm) implantation with the large FlexNav Delivery system and Navitor Loading System - LG+.
Navitor Titan Valve (35mm) Valve and Large FlexNav™ Delivery System: Subjects will undergo transcatheter aortic valve implantation (TAVI) with the Navitor Titan valve and large FlexNav Delivery system via a transfemoral or alternative access approach according to the site's anesthesia protocol for TAVR procedures.
|
|---|---|---|
|
Primary Safety Endpoint is All-cause Mortality
|
5 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: at 30 daysPopulation: All available subjects with echocardiographic data have been analyzed.
Number of participants with moderate or greater paravalvular leak at 30 days.
Outcome measures
| Measure |
Portico™ NG (Navitor) Valve, FlexNav™ Delivery System
n=248 Participants
Portico ™ NG (Navitor) valve implantation with the new generation Portico NG (Navitor) valve (23mm, 25mm, 27mm and 29mm sizes), and the second-generation FlexNav Delivery system (small and large), Portico™ NG (Navitor) Loading System(s) (small and large).
Portico™ NG (Navitor) Valve and FlexNav™ Delivery System: Subjects will undergo transcatheter aortic valve implantation (TAVI) with the new generation Portico NG (Navitor) valve and second-generation FlexNav Delivery system via a transfemoral or alternative access approach according to the site's anesthesia protocol for TAVR procedures.
|
Navitor Titan Valve
n=68 Participants
Navitor Titan Valve (35mm) implantation with the large FlexNav Delivery system and Navitor Loading System - LG+.
Navitor Titan Valve (35mm) Valve and Large FlexNav™ Delivery System: Subjects will undergo transcatheter aortic valve implantation (TAVI) with the Navitor Titan valve and large FlexNav Delivery system via a transfemoral or alternative access approach according to the site's anesthesia protocol for TAVR procedures.
|
|---|---|---|
|
Primary Effectiveness Endpoint is Moderate or Greater Paravalvular Leak
None/Trace PVL
|
198 Participants
|
61 Participants
|
|
Primary Effectiveness Endpoint is Moderate or Greater Paravalvular Leak
Mild PVL
|
50 Participants
|
7 Participants
|
|
Primary Effectiveness Endpoint is Moderate or Greater Paravalvular Leak
Moderate PVL
|
0 Participants
|
0 Participants
|
|
Primary Effectiveness Endpoint is Moderate or Greater Paravalvular Leak
Severe PVL
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: at 30 daysThe secondary endpoint is defined as a non-hierarchical composite of all-cause mortality, disabling stroke, life threatening bleeding, acute kidney injury (stage 3), or major vascular complications at 30 days.
Outcome measures
| Measure |
Portico™ NG (Navitor) Valve, FlexNav™ Delivery System
n=260 Participants
Portico ™ NG (Navitor) valve implantation with the new generation Portico NG (Navitor) valve (23mm, 25mm, 27mm and 29mm sizes), and the second-generation FlexNav Delivery system (small and large), Portico™ NG (Navitor) Loading System(s) (small and large).
Portico™ NG (Navitor) Valve and FlexNav™ Delivery System: Subjects will undergo transcatheter aortic valve implantation (TAVI) with the new generation Portico NG (Navitor) valve and second-generation FlexNav Delivery system via a transfemoral or alternative access approach according to the site's anesthesia protocol for TAVR procedures.
|
Navitor Titan Valve
n=73 Participants
Navitor Titan Valve (35mm) implantation with the large FlexNav Delivery system and Navitor Loading System - LG+.
Navitor Titan Valve (35mm) Valve and Large FlexNav™ Delivery System: Subjects will undergo transcatheter aortic valve implantation (TAVI) with the Navitor Titan valve and large FlexNav Delivery system via a transfemoral or alternative access approach according to the site's anesthesia protocol for TAVR procedures.
|
|---|---|---|
|
Non-hierarchical Composite of All-cause Mortality, Disabling Stroke, Life Threatening Bleeding, Acute Kidney Injury (Stage 3), or Major Vascular Complications
All-Cause Mortality
|
5 Participants
|
1 Participants
|
|
Non-hierarchical Composite of All-cause Mortality, Disabling Stroke, Life Threatening Bleeding, Acute Kidney Injury (Stage 3), or Major Vascular Complications
Myocardial Infarction
|
2 Participants
|
1 Participants
|
|
Non-hierarchical Composite of All-cause Mortality, Disabling Stroke, Life Threatening Bleeding, Acute Kidney Injury (Stage 3), or Major Vascular Complications
All Stroke
|
10 Participants
|
2 Participants
|
|
Non-hierarchical Composite of All-cause Mortality, Disabling Stroke, Life Threatening Bleeding, Acute Kidney Injury (Stage 3), or Major Vascular Complications
Transient Ischemic Attack
|
2 Participants
|
2 Participants
|
|
Non-hierarchical Composite of All-cause Mortality, Disabling Stroke, Life Threatening Bleeding, Acute Kidney Injury (Stage 3), or Major Vascular Complications
Life-Threatening Bleeding
|
10 Participants
|
0 Participants
|
|
Non-hierarchical Composite of All-cause Mortality, Disabling Stroke, Life Threatening Bleeding, Acute Kidney Injury (Stage 3), or Major Vascular Complications
Major Bleeding
|
12 Participants
|
2 Participants
|
|
Non-hierarchical Composite of All-cause Mortality, Disabling Stroke, Life Threatening Bleeding, Acute Kidney Injury (Stage 3), or Major Vascular Complications
Major Vascular Complications
|
11 Participants
|
3 Participants
|
|
Non-hierarchical Composite of All-cause Mortality, Disabling Stroke, Life Threatening Bleeding, Acute Kidney Injury (Stage 3), or Major Vascular Complications
Acute Kidney Injury
|
5 Participants
|
0 Participants
|
|
Non-hierarchical Composite of All-cause Mortality, Disabling Stroke, Life Threatening Bleeding, Acute Kidney Injury (Stage 3), or Major Vascular Complications
Valve Thrombosis
|
0 Participants
|
0 Participants
|
Adverse Events
Portico™ NG (Navitor) Valve, FlexNav™ Delivery System
Serious events: 180 serious events
Other events: 197 other events
Deaths: 44 deaths
Navitor Titan Valve
Serious events: 50 serious events
Other events: 54 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Portico™ NG (Navitor) Valve, FlexNav™ Delivery System
n=260 participants at risk
Portico ™ NG (Navitor) valve implantation with the new generation Portico NG (Navitor) valve (23mm, 25mm, 27mm and 29mm sizes), and the second-generation FlexNav Delivery system (small and large), Portico™ NG (Navitor) Loading System(s) (small and large).
Portico™ NG (Navitor) Valve and FlexNav™ Delivery System: Subjects will undergo transcatheter aortic valve implantation (TAVI) with the new generation Portico NG (Navitor) valve and second-generation FlexNav Delivery system via a transfemoral or alternative access approach according to the site's anesthesia protocol for TAVR procedures.
|
Navitor Titan Valve
n=73 participants at risk
Navitor Titan Valve (35mm) implantation with the large FlexNav Delivery system and Navitor Loading System - LG+.
Navitor Titan Valve (35mm) Valve and Large FlexNav™ Delivery System: Subjects will undergo transcatheter aortic valve implantation (TAVI) with the Navitor Titan valve and large FlexNav Delivery system via a transfemoral or alternative access approach according to the site's anesthesia protocol for TAVR procedures.
|
|---|---|---|
|
Cardiac disorders
Angina Pectoris
|
5.0%
13/260 • Number of events 17 • All Adverse Events through 3 year follow-up visit.
|
2.7%
2/73 • Number of events 2 • All Adverse Events through 3 year follow-up visit.
|
|
Cardiac disorders
Aortic Dissection
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
1.4%
1/73 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
|
Cardiac disorders
Aortic Aneurysm
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Cardiac disorders
Arrhythmias
|
10.0%
26/260 • Number of events 34 • All Adverse Events through 3 year follow-up visit.
|
9.6%
7/73 • Number of events 8 • All Adverse Events through 3 year follow-up visit.
|
|
Cardiac disorders
Arterial Hypertension
|
2.3%
6/260 • Number of events 6 • All Adverse Events through 3 year follow-up visit.
|
1.4%
1/73 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
|
Cardiac disorders
Cardiac Arrest
|
1.5%
4/260 • Number of events 4 • All Adverse Events through 3 year follow-up visit.
|
2.7%
2/73 • Number of events 2 • All Adverse Events through 3 year follow-up visit.
|
|
Cardiac disorders
Cardiac Perforation
|
0.77%
2/260 • Number of events 2 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Cardiac disorders
Coronary Artery Disease
|
0.77%
2/260 • Number of events 2 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Cardiac disorders
EKG Finding
|
2.3%
6/260 • Number of events 6 • All Adverse Events through 3 year follow-up visit.
|
2.7%
2/73 • Number of events 2 • All Adverse Events through 3 year follow-up visit.
|
|
Cardiac disorders
Echo Finding
|
1.2%
3/260 • Number of events 3 • All Adverse Events through 3 year follow-up visit.
|
1.4%
1/73 • Number of events 2 • All Adverse Events through 3 year follow-up visit.
|
|
Cardiac disorders
Endocarditis
|
1.5%
4/260 • Number of events 4 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Cardiac disorders
General - Cardiovascular Symptoms
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Cardiac disorders
Heart Block
|
0.77%
2/260 • Number of events 2 • All Adverse Events through 3 year follow-up visit.
|
2.7%
2/73 • Number of events 2 • All Adverse Events through 3 year follow-up visit.
|
|
Cardiac disorders
AV Block
|
1.2%
3/260 • Number of events 3 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Cardiac disorders
First Degree Heart/AV Block/Cardiac Arrhythmia - 1st degree AV Block
|
1.2%
3/260 • Number of events 3 • All Adverse Events through 3 year follow-up visit.
|
4.1%
3/73 • Number of events 3 • All Adverse Events through 3 year follow-up visit.
|
|
Cardiac disorders
Left Bundle Branch Block/Complete Left Bundle Branch Block
|
3.8%
10/260 • Number of events 10 • All Adverse Events through 3 year follow-up visit.
|
9.6%
7/73 • Number of events 7 • All Adverse Events through 3 year follow-up visit.
|
|
Cardiac disorders
Mobitz II Block
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
1.4%
1/73 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
|
Cardiac disorders
Right Bundle Branch Block/Complete Right Bundle Branch Block
|
0.77%
2/260 • Number of events 2 • All Adverse Events through 3 year follow-up visit.
|
1.4%
1/73 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
|
Cardiac disorders
Third Degree Heart Block (Complete Heart Block)
|
10.8%
28/260 • Number of events 28 • All Adverse Events through 3 year follow-up visit.
|
15.1%
11/73 • Number of events 11 • All Adverse Events through 3 year follow-up visit.
|
|
Cardiac disorders
Heart Failure
|
8.8%
23/260 • Number of events 31 • All Adverse Events through 3 year follow-up visit.
|
12.3%
9/73 • Number of events 12 • All Adverse Events through 3 year follow-up visit.
|
|
Cardiac disorders
Heart Murmur
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Cardiac disorders
Hypertensive Crisis
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Cardiac disorders
Hypotension
|
5.4%
14/260 • Number of events 14 • All Adverse Events through 3 year follow-up visit.
|
2.7%
2/73 • Number of events 2 • All Adverse Events through 3 year follow-up visit.
|
|
Cardiac disorders
Myocardial Infarction
|
2.7%
7/260 • Number of events 7 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Cardiac disorders
Myocardial Ischemia
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Cardiac disorders
Pericardial Effusion
|
1.9%
5/260 • Number of events 5 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Cardiac disorders
Pericardial Tamponade
|
1.2%
3/260 • Number of events 3 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Cardiac disorders
Pulmonary Hypertension
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Cardiac disorders
Shock
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Cardiac disorders
Valve
|
2.7%
7/260 • Number of events 9 • All Adverse Events through 3 year follow-up visit.
|
1.4%
1/73 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
|
Skin and subcutaneous tissue disorders
Benign Tumors
|
0.77%
2/260 • Number of events 2 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
2.7%
7/260 • Number of events 7 • All Adverse Events through 3 year follow-up visit.
|
1.4%
1/73 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
|
Skin and subcutaneous tissue disorders
Skin Cancer
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Skin and subcutaneous tissue disorders
Skin Ulcer
|
0.77%
2/260 • Number of events 2 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Ear and labyrinth disorders
Nose and Paranasal Sinuses
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Ear and labyrinth disorders
Tympanic Membrane and Ear
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Skin and subcutaneous tissue disorders
Vertigo
|
0.77%
2/260 • Number of events 2 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Endocrine disorders
Dehydration
|
1.2%
3/260 • Number of events 3 • All Adverse Events through 3 year follow-up visit.
|
1.4%
1/73 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
|
Endocrine disorders
Disorders of Carbohydrate Metabolism
|
2.3%
6/260 • Number of events 6 • All Adverse Events through 3 year follow-up visit.
|
1.4%
1/73 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
|
Endocrine disorders
Hyperkalemia
|
1.2%
3/260 • Number of events 3 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Endocrine disorders
Hypernatremia
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Endocrine disorders
Hypokalemia
|
1.2%
3/260 • Number of events 3 • All Adverse Events through 3 year follow-up visit.
|
1.4%
1/73 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
|
Endocrine disorders
Hyponatremia
|
0.77%
2/260 • Number of events 2 • All Adverse Events through 3 year follow-up visit.
|
2.7%
2/73 • Number of events 2 • All Adverse Events through 3 year follow-up visit.
|
|
Gastrointestinal disorders
Appendicitis
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Gastrointestinal disorders
Bowel Obstruction
|
1.2%
3/260 • Number of events 4 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Gastrointestinal disorders
Colon Polyps
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Gastrointestinal disorders
Constipation
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Gastrointestinal disorders
Diverticular Disease
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Gastrointestinal disorders
Dysphagia
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Gastrointestinal disorders
Gastrointestinal Bleeding
|
3.8%
10/260 • Number of events 13 • All Adverse Events through 3 year follow-up visit.
|
4.1%
3/73 • Number of events 3 • All Adverse Events through 3 year follow-up visit.
|
|
Gastrointestinal disorders
Hepatic and Biliary Disorders
|
1.9%
5/260 • Number of events 9 • All Adverse Events through 3 year follow-up visit.
|
2.7%
2/73 • Number of events 2 • All Adverse Events through 3 year follow-up visit.
|
|
Gastrointestinal disorders
Hernia
|
0.77%
2/260 • Number of events 2 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Gastrointestinal disorders
Melena
|
1.2%
3/260 • Number of events 3 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.38%
1/260 • Number of events 2 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Gastrointestinal disorders
Tumors
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
1.4%
1/73 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
5.0%
13/260 • Number of events 14 • All Adverse Events through 3 year follow-up visit.
|
9.6%
7/73 • Number of events 8 • All Adverse Events through 3 year follow-up visit.
|
|
Renal and urinary disorders
Hematuria
|
1.2%
3/260 • Number of events 3 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Renal and urinary disorders
Prostate Disease
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
2.7%
2/73 • Number of events 2 • All Adverse Events through 3 year follow-up visit.
|
|
Renal and urinary disorders
Renal Failure
|
2.3%
6/260 • Number of events 6 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Renal and urinary disorders
Renal Insufficiency
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Renal and urinary disorders
Urinary Retention
|
2.3%
6/260 • Number of events 7 • All Adverse Events through 3 year follow-up visit.
|
1.4%
1/73 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
|
Renal and urinary disorders
Urinary Tract Infections
|
4.2%
11/260 • Number of events 15 • All Adverse Events through 3 year follow-up visit.
|
4.1%
3/73 • Number of events 5 • All Adverse Events through 3 year follow-up visit.
|
|
General disorders
Breast Cancer
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Blood and lymphatic system disorders
Abnormal Lab Value
|
0.77%
2/260 • Number of events 3 • All Adverse Events through 3 year follow-up visit.
|
2.7%
2/73 • Number of events 2 • All Adverse Events through 3 year follow-up visit.
|
|
Blood and lymphatic system disorders
Anemias
|
5.8%
15/260 • Number of events 19 • All Adverse Events through 3 year follow-up visit.
|
4.1%
3/73 • Number of events 3 • All Adverse Events through 3 year follow-up visit.
|
|
Blood and lymphatic system disorders
Bacteremia
|
1.2%
3/260 • Number of events 3 • All Adverse Events through 3 year follow-up visit.
|
2.7%
2/73 • Number of events 2 • All Adverse Events through 3 year follow-up visit.
|
|
Blood and lymphatic system disorders
Bleeding
|
1.5%
4/260 • Number of events 4 • All Adverse Events through 3 year follow-up visit.
|
1.4%
1/73 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
|
Blood and lymphatic system disorders
Blood Loss
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Blood and lymphatic system disorders
Deep Vein/Venous Thrombosis
|
0.77%
2/260 • Number of events 2 • All Adverse Events through 3 year follow-up visit.
|
1.4%
1/73 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
|
Blood and lymphatic system disorders
Hematoma
|
0.77%
2/260 • Number of events 2 • All Adverse Events through 3 year follow-up visit.
|
1.4%
1/73 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
|
Blood and lymphatic system disorders
Leukemias
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
1.4%
1/73 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.7%
7/260 • Number of events 7 • All Adverse Events through 3 year follow-up visit.
|
2.7%
2/73 • Number of events 2 • All Adverse Events through 3 year follow-up visit.
|
|
Blood and lymphatic system disorders
Thrombus
|
0.77%
2/260 • Number of events 2 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Infections and infestations
Bacterial Infections
|
0.77%
2/260 • Number of events 2 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Infections and infestations
C. Difficile Infection
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
1.4%
1/73 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
|
Infections and infestations
Miscellaneous Infections
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Infections and infestations
Sepsis
|
3.5%
9/260 • Number of events 9 • All Adverse Events through 3 year follow-up visit.
|
1.4%
1/73 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
|
Infections and infestations
Septicemia
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Injury, poisoning and procedural complications
Cancer
|
0.00%
0/260 • All Adverse Events through 3 year follow-up visit.
|
4.1%
3/73 • Number of events 3 • All Adverse Events through 3 year follow-up visit.
|
|
Injury, poisoning and procedural complications
Claudication
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Injury, poisoning and procedural complications
Device/Delivery System
|
0.00%
0/260 • All Adverse Events through 3 year follow-up visit.
|
1.4%
1/73 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
|
Injury, poisoning and procedural complications
Emesis/Vomiting
|
0.77%
2/260 • Number of events 2 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/260 • All Adverse Events through 3 year follow-up visit.
|
4.1%
3/73 • Number of events 3 • All Adverse Events through 3 year follow-up visit.
|
|
Injury, poisoning and procedural complications
Fever
|
0.00%
0/260 • All Adverse Events through 3 year follow-up visit.
|
2.7%
2/73 • Number of events 2 • All Adverse Events through 3 year follow-up visit.
|
|
Injury, poisoning and procedural complications
Lacerations
|
0.77%
2/260 • Number of events 2 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Injury, poisoning and procedural complications
Nausea
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Injury, poisoning and procedural complications
Non-Cardiac Chest Pain
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Injury, poisoning and procedural complications
Non-Study Procedure Complication
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Injury, poisoning and procedural complications
Other
|
0.00%
0/260 • All Adverse Events through 3 year follow-up visit.
|
21.9%
16/73 • Number of events 26 • All Adverse Events through 3 year follow-up visit.
|
|
Injury, poisoning and procedural complications
Swelling
|
0.77%
2/260 • Number of events 2 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Injury, poisoning and procedural complications
Trauma
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Injury, poisoning and procedural complications
Vascular Dissection
|
1.2%
3/260 • Number of events 3 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Injury, poisoning and procedural complications
Weakness
|
0.77%
2/260 • Number of events 2 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Injury, poisoning and procedural complications
Wound Dehiscence
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
3.1%
8/260 • Number of events 9 • All Adverse Events through 3 year follow-up visit.
|
2.7%
2/73 • Number of events 3 • All Adverse Events through 3 year follow-up visit.
|
|
Musculoskeletal and connective tissue disorders
General - Musculoskeletal Symptoms
|
1.5%
4/260 • Number of events 4 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis/Degenerative Joint Disease
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Musculoskeletal and connective tissue disorders
Spinal Cord Disorders
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Musculoskeletal and connective tissue disorders
Toe Inflammation
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Nervous system disorders
Amnesia
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Nervous system disorders
Aphasia
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Nervous system disorders
Arteriovenous Malformation
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Nervous system disorders
Carotid Stenosis
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Nervous system disorders
Carpal Tunnel
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Nervous system disorders
Cognitive Impairment
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Nervous system disorders
Delirium
|
0.77%
2/260 • Number of events 2 • All Adverse Events through 3 year follow-up visit.
|
1.4%
1/73 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
|
Nervous system disorders
Dementia
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Nervous system disorders
Depression
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Nervous system disorders
Encephalopathy
|
1.2%
3/260 • Number of events 3 • All Adverse Events through 3 year follow-up visit.
|
2.7%
2/73 • Number of events 2 • All Adverse Events through 3 year follow-up visit.
|
|
Nervous system disorders
General - Neurological Symptoms
|
1.2%
3/260 • Number of events 3 • All Adverse Events through 3 year follow-up visit.
|
1.4%
1/73 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
|
Nervous system disorders
Hemiparesis/Weakness
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Nervous system disorders
Hemorrhage
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
1.4%
1/73 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
|
Nervous system disorders
Hydrocephalus
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Nervous system disorders
Neurological Hematoma
|
1.2%
3/260 • Number of events 4 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Nervous system disorders
Presyncope
|
0.77%
2/260 • Number of events 2 • All Adverse Events through 3 year follow-up visit.
|
1.4%
1/73 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
|
Nervous system disorders
Seizure/Convulsions/Epilepsy
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Nervous system disorders
Stroke
|
5.8%
15/260 • Number of events 16 • All Adverse Events through 3 year follow-up visit.
|
4.1%
3/73 • Number of events 3 • All Adverse Events through 3 year follow-up visit.
|
|
Nervous system disorders
Syncope
|
3.5%
9/260 • Number of events 10 • All Adverse Events through 3 year follow-up visit.
|
1.4%
1/73 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
|
Nervous system disorders
Transient Ischemic Attack (TIA)
|
2.7%
7/260 • Number of events 11 • All Adverse Events through 3 year follow-up visit.
|
2.7%
2/73 • Number of events 2 • All Adverse Events through 3 year follow-up visit.
|
|
Nervous system disorders
Vaso Vagal Response
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
2.7%
2/73 • Number of events 2 • All Adverse Events through 3 year follow-up visit.
|
|
Eye disorders
Macular Degeneration
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Airway Disorders
|
1.2%
3/260 • Number of events 3 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.5%
4/260 • Number of events 4 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
1.4%
1/73 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
|
Respiratory, thoracic and mediastinal disorders
Hypersensitivity Diseases of the Lungs
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxemia
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
2.7%
2/73 • Number of events 2 • All Adverse Events through 3 year follow-up visit.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
1.4%
1/73 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
|
Respiratory, thoracic and mediastinal disorders
Lung Cancer
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Disorders
|
3.1%
8/260 • Number of events 12 • All Adverse Events through 3 year follow-up visit.
|
2.7%
2/73 • Number of events 2 • All Adverse Events through 3 year follow-up visit.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
6.5%
17/260 • Number of events 18 • All Adverse Events through 3 year follow-up visit.
|
5.5%
4/73 • Number of events 4 • All Adverse Events through 3 year follow-up visit.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
3.5%
9/260 • Number of events 10 • All Adverse Events through 3 year follow-up visit.
|
5.5%
4/73 • Number of events 6 • All Adverse Events through 3 year follow-up visit.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Illness
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Respiratory, thoracic and mediastinal disorders
Wheeze
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Vascular disorders
VASC Bleeding
|
1.5%
4/260 • Number of events 5 • All Adverse Events through 3 year follow-up visit.
|
1.4%
1/73 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
|
Vascular disorders
VASC Hematoma
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Vascular disorders
VASC Pseudoaneurysm
|
1.5%
4/260 • Number of events 4 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Vascular disorders
VASC Vessel Perforation
|
0.77%
2/260 • Number of events 2 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Gastrointestinal disorders
Duodenal Ulcer
|
0.00%
0/260 • All Adverse Events through 3 year follow-up visit.
|
1.4%
1/73 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
|
Injury, poisoning and procedural complications
Elective Procedure
|
0.00%
0/260 • All Adverse Events through 3 year follow-up visit.
|
1.4%
1/73 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
Other adverse events
| Measure |
Portico™ NG (Navitor) Valve, FlexNav™ Delivery System
n=260 participants at risk
Portico ™ NG (Navitor) valve implantation with the new generation Portico NG (Navitor) valve (23mm, 25mm, 27mm and 29mm sizes), and the second-generation FlexNav Delivery system (small and large), Portico™ NG (Navitor) Loading System(s) (small and large).
Portico™ NG (Navitor) Valve and FlexNav™ Delivery System: Subjects will undergo transcatheter aortic valve implantation (TAVI) with the new generation Portico NG (Navitor) valve and second-generation FlexNav Delivery system via a transfemoral or alternative access approach according to the site's anesthesia protocol for TAVR procedures.
|
Navitor Titan Valve
n=73 participants at risk
Navitor Titan Valve (35mm) implantation with the large FlexNav Delivery system and Navitor Loading System - LG+.
Navitor Titan Valve (35mm) Valve and Large FlexNav™ Delivery System: Subjects will undergo transcatheter aortic valve implantation (TAVI) with the Navitor Titan valve and large FlexNav Delivery system via a transfemoral or alternative access approach according to the site's anesthesia protocol for TAVR procedures.
|
|---|---|---|
|
Cardiac disorders
Angina Pectoris
|
4.2%
11/260 • Number of events 11 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Cardiac disorders
Arrhythmias
|
11.5%
30/260 • Number of events 32 • All Adverse Events through 3 year follow-up visit.
|
12.3%
9/73 • Number of events 9 • All Adverse Events through 3 year follow-up visit.
|
|
Cardiac disorders
Arterial Hypertension
|
7.3%
19/260 • Number of events 20 • All Adverse Events through 3 year follow-up visit.
|
1.4%
1/73 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
|
Cardiac disorders
EKG Finding
|
3.1%
8/260 • Number of events 8 • All Adverse Events through 3 year follow-up visit.
|
2.7%
2/73 • Number of events 2 • All Adverse Events through 3 year follow-up visit.
|
|
Cardiac disorders
Echo Finding
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
1.4%
1/73 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
|
Cardiac disorders
General - Cardiovascular Symptoms
|
0.77%
2/260 • Number of events 2 • All Adverse Events through 3 year follow-up visit.
|
1.4%
1/73 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
|
Cardiac disorders
Heart Block
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Cardiac disorders
AV Block
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Cardiac disorders
First Degree Heart/AV Block/Cardiac Arrhythmia - 1st degree AV Block
|
4.6%
12/260 • Number of events 12 • All Adverse Events through 3 year follow-up visit.
|
2.7%
2/73 • Number of events 2 • All Adverse Events through 3 year follow-up visit.
|
|
Cardiac disorders
High Grade Block/Advanced AV Block
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Cardiac disorders
Incomplete Left Bundle Branch Block
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Cardiac disorders
Left Bundle Branch Block/Complete Left Bundle Branch Block
|
18.8%
49/260 • Number of events 50 • All Adverse Events through 3 year follow-up visit.
|
17.8%
13/73 • Number of events 13 • All Adverse Events through 3 year follow-up visit.
|
|
Cardiac disorders
Right Bundle Branch Block/Complete Right Bundle Branch Block
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
1.4%
1/73 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
|
Cardiac disorders
Second Degree Heart Block
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
1.4%
1/73 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
|
Cardiac disorders
Third Degree Heart Block (Complete Heart Block)
|
1.2%
3/260 • Number of events 3 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Cardiac disorders
Heart Failure
|
6.2%
16/260 • Number of events 16 • All Adverse Events through 3 year follow-up visit.
|
5.5%
4/73 • Number of events 5 • All Adverse Events through 3 year follow-up visit.
|
|
Cardiac disorders
Hypertensive Crisis
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Cardiac disorders
Hypotension
|
5.0%
13/260 • Number of events 13 • All Adverse Events through 3 year follow-up visit.
|
6.8%
5/73 • Number of events 6 • All Adverse Events through 3 year follow-up visit.
|
|
Cardiac disorders
Myocardial Infarction
|
1.2%
3/260 • Number of events 4 • All Adverse Events through 3 year follow-up visit.
|
1.4%
1/73 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
|
Cardiac disorders
Myocardial Ischemia
|
1.2%
3/260 • Number of events 3 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Cardiac disorders
Pericardial Effusion
|
0.77%
2/260 • Number of events 2 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Cardiac disorders
Pulmonary Hypertension
|
1.5%
4/260 • Number of events 4 • All Adverse Events through 3 year follow-up visit.
|
1.4%
1/73 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
|
Cardiac disorders
Sinus Node Dysfunction
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Cardiac disorders
Valve
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
1.4%
1/73 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
|
Skin and subcutaneous tissue disorders
Abrasion
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Skin and subcutaneous tissue disorders
Contusion
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.77%
2/260 • Number of events 2 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Skin and subcutaneous tissue disorders
Disorders of Cornification
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.2%
3/260 • Number of events 3 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Skin and subcutaneous tissue disorders
Skin Ulcer
|
0.77%
2/260 • Number of events 2 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Ear and labyrinth disorders
Dental Disorders
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Ear and labyrinth disorders
Nose and Paranasal Sinuses
|
1.5%
4/260 • Number of events 4 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Ear and labyrinth disorders
Tympanic Membrane and Ear
|
1.2%
3/260 • Number of events 3 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Ear and labyrinth disorders
Vertigo
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Endocrine disorders
Disorders of Carbohydrate Metabolism
|
1.5%
4/260 • Number of events 4 • All Adverse Events through 3 year follow-up visit.
|
1.4%
1/73 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
|
Endocrine disorders
Hyperkalemia
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Endocrine disorders
Hypernatremia
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Endocrine disorders
Hypokalemia
|
1.5%
4/260 • Number of events 4 • All Adverse Events through 3 year follow-up visit.
|
1.4%
1/73 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
|
Endocrine disorders
Hyponatremia
|
1.5%
4/260 • Number of events 4 • All Adverse Events through 3 year follow-up visit.
|
1.4%
1/73 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
|
Endocrine disorders
Thyroid Disorders
|
1.5%
4/260 • Number of events 4 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Gastrointestinal disorders
Colon Polyps
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Gastrointestinal disorders
Constipation
|
1.9%
5/260 • Number of events 8 • All Adverse Events through 3 year follow-up visit.
|
1.4%
1/73 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
|
Gastrointestinal disorders
Diarrhea
|
1.2%
3/260 • Number of events 4 • All Adverse Events through 3 year follow-up visit.
|
1.4%
1/73 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
|
Gastrointestinal disorders
Gastritis
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Gastrointestinal disorders
Gastrointestinal Bleeding
|
0.77%
2/260 • Number of events 2 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Gastrointestinal disorders
Hemorrhoids/Piles
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Gastrointestinal disorders
Hepatic and Biliary Disorders
|
0.77%
2/260 • Number of events 2 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
General disorders
Acute Kidney Injury
|
4.6%
12/260 • Number of events 13 • All Adverse Events through 3 year follow-up visit.
|
1.4%
1/73 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
|
General disorders
Dysuria
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
General disorders
Edema
|
1.9%
5/260 • Number of events 6 • All Adverse Events through 3 year follow-up visit.
|
1.4%
1/73 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
|
General disorders
Hematuria
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
General disorders
Prostate Disease
|
0.77%
2/260 • Number of events 2 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
General disorders
Renal Insufficiency
|
0.77%
2/260 • Number of events 2 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
General disorders
Urinary Retention
|
1.5%
4/260 • Number of events 4 • All Adverse Events through 3 year follow-up visit.
|
2.7%
2/73 • Number of events 2 • All Adverse Events through 3 year follow-up visit.
|
|
General disorders
Urinary Tract Infections
|
5.8%
15/260 • Number of events 16 • All Adverse Events through 3 year follow-up visit.
|
4.1%
3/73 • Number of events 4 • All Adverse Events through 3 year follow-up visit.
|
|
General disorders
Breast Cancer
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Blood and lymphatic system disorders
Abnormal Lab Value
|
0.77%
2/260 • Number of events 2 • All Adverse Events through 3 year follow-up visit.
|
5.5%
4/73 • Number of events 4 • All Adverse Events through 3 year follow-up visit.
|
|
Blood and lymphatic system disorders
Anemias
|
5.8%
15/260 • Number of events 15 • All Adverse Events through 3 year follow-up visit.
|
11.0%
8/73 • Number of events 8 • All Adverse Events through 3 year follow-up visit.
|
|
Blood and lymphatic system disorders
Bleeding
|
1.9%
5/260 • Number of events 6 • All Adverse Events through 3 year follow-up visit.
|
1.4%
1/73 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
|
Blood and lymphatic system disorders
Hematoma
|
4.6%
12/260 • Number of events 13 • All Adverse Events through 3 year follow-up visit.
|
1.4%
1/73 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
4.6%
12/260 • Number of events 12 • All Adverse Events through 3 year follow-up visit.
|
5.5%
4/73 • Number of events 4 • All Adverse Events through 3 year follow-up visit.
|
|
Blood and lymphatic system disorders
Thrombus
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Infections and infestations
Bacterial Infections
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Infections and infestations
C. Difficile Infection
|
0.38%
1/260 • Number of events 2 • All Adverse Events through 3 year follow-up visit.
|
1.4%
1/73 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
|
Infections and infestations
Viral
|
3.8%
10/260 • Number of events 10 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Injury, poisoning and procedural complications
Cancer
|
0.00%
0/260 • All Adverse Events through 3 year follow-up visit.
|
1.4%
1/73 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
|
Injury, poisoning and procedural complications
Claudication
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Injury, poisoning and procedural complications
Device/Delivery System
|
0.00%
0/260 • All Adverse Events through 3 year follow-up visit.
|
1.4%
1/73 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
|
Injury, poisoning and procedural complications
Elective Surgery
|
0.00%
0/260 • All Adverse Events through 3 year follow-up visit.
|
1.4%
1/73 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
|
Injury, poisoning and procedural complications
Emesis/Vomiting
|
0.77%
2/260 • Number of events 2 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/260 • All Adverse Events through 3 year follow-up visit.
|
4.1%
3/73 • Number of events 3 • All Adverse Events through 3 year follow-up visit.
|
|
Injury, poisoning and procedural complications
Fever
|
0.00%
0/260 • All Adverse Events through 3 year follow-up visit.
|
1.4%
1/73 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
|
Injury, poisoning and procedural complications
Lacerations
|
0.00%
0/260 • All Adverse Events through 3 year follow-up visit.
|
1.4%
1/73 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
|
Injury, poisoning and procedural complications
Nausea
|
1.2%
3/260 • Number of events 3 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Injury, poisoning and procedural complications
Non-Cardiac Chest Pain
|
0.77%
2/260 • Number of events 2 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Injury, poisoning and procedural complications
Other
|
0.00%
0/260 • All Adverse Events through 3 year follow-up visit.
|
17.8%
13/73 • Number of events 20 • All Adverse Events through 3 year follow-up visit.
|
|
Injury, poisoning and procedural complications
Pain
|
0.00%
0/260 • All Adverse Events through 3 year follow-up visit.
|
1.4%
1/73 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
|
Injury, poisoning and procedural complications
Poison Ivy
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Injury, poisoning and procedural complications
Swelling
|
0.00%
0/260 • All Adverse Events through 3 year follow-up visit.
|
1.4%
1/73 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
|
Injury, poisoning and procedural complications
Trauma
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Injury, poisoning and procedural complications
Weakness
|
0.77%
2/260 • Number of events 2 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Injury, poisoning and procedural complications
Weight Loss
|
1.2%
3/260 • Number of events 3 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Musculoskeletal and connective tissue disorders
Arthritis Associated with Spondylitis
|
1.2%
3/260 • Number of events 3 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Musculoskeletal and connective tissue disorders
Digit Injury, Finger/Toe
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
1.9%
5/260 • Number of events 5 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Musculoskeletal and connective tissue disorders
General - Musculoskeletal Symptoms
|
3.8%
10/260 • Number of events 10 • All Adverse Events through 3 year follow-up visit.
|
5.5%
4/73 • Number of events 4 • All Adverse Events through 3 year follow-up visit.
|
|
Musculoskeletal and connective tissue disorders
Gout
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Musculoskeletal and connective tissue disorders
Muscle Strain
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Musculoskeletal and connective tissue disorders
Rotator Cuff Tear
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Nervous system disorders
Altered Sensorium
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Nervous system disorders
Amnesia
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Nervous system disorders
Carotid Stenosis
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Nervous system disorders
Cerebral Aneurysm
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Nervous system disorders
Cognitive Impairment
|
1.2%
3/260 • Number of events 3 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Nervous system disorders
Delirium
|
0.77%
2/260 • Number of events 2 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Nervous system disorders
Dementia
|
1.9%
5/260 • Number of events 5 • All Adverse Events through 3 year follow-up visit.
|
1.4%
1/73 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
|
Nervous system disorders
Depression
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Nervous system disorders
Dysautonomia
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Nervous system disorders
Encephalopathy
|
0.77%
2/260 • Number of events 2 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Nervous system disorders
General - Neurological Symptoms
|
6.2%
16/260 • Number of events 16 • All Adverse Events through 3 year follow-up visit.
|
2.7%
2/73 • Number of events 3 • All Adverse Events through 3 year follow-up visit.
|
|
Nervous system disorders
Hallucinations
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Nervous system disorders
Hemorrhage
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Nervous system disorders
Lightheadedness
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Nervous system disorders
Speech Difficulty
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Nervous system disorders
Stroke
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
2.7%
2/73 • Number of events 2 • All Adverse Events through 3 year follow-up visit.
|
|
Nervous system disorders
Syncope
|
1.9%
5/260 • Number of events 5 • All Adverse Events through 3 year follow-up visit.
|
2.7%
2/73 • Number of events 2 • All Adverse Events through 3 year follow-up visit.
|
|
Nervous system disorders
Transient Ischemic Attack (TIA)
|
1.2%
3/260 • Number of events 3 • All Adverse Events through 3 year follow-up visit.
|
5.5%
4/73 • Number of events 4 • All Adverse Events through 3 year follow-up visit.
|
|
Nervous system disorders
Vaso Vagal Response
|
0.77%
2/260 • Number of events 2 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Eye disorders
Cataract
|
0.77%
2/260 • Number of events 3 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
1.2%
3/260 • Number of events 3 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Airway Disorders
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
1.4%
1/73 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
|
Respiratory, thoracic and mediastinal disorders
Difficulty Catching Breath
|
1.2%
3/260 • Number of events 3 • All Adverse Events through 3 year follow-up visit.
|
1.4%
1/73 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.5%
4/260 • Number of events 4 • All Adverse Events through 3 year follow-up visit.
|
1.4%
1/73 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
0.77%
2/260 • Number of events 2 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic Interstitial Lung Diseases
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Respiratory, thoracic and mediastinal disorders
Lung Cancer
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Disorders
|
3.1%
8/260 • Number of events 9 • All Adverse Events through 3 year follow-up visit.
|
2.7%
2/73 • Number of events 2 • All Adverse Events through 3 year follow-up visit.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
1.5%
4/260 • Number of events 4 • All Adverse Events through 3 year follow-up visit.
|
2.7%
2/73 • Number of events 2 • All Adverse Events through 3 year follow-up visit.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Nodule
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
1.4%
1/73 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Illness
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Respiratory, thoracic and mediastinal disorders
X-ray Finding
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Vascular disorders
VASC Hematoma
|
0.77%
2/260 • Number of events 2 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Vascular disorders
VASC Pseudoaneurysm
|
0.38%
1/260 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
0.00%
0/73 • All Adverse Events through 3 year follow-up visit.
|
|
Skin and subcutaneous tissue disorders
Skin Bruise
|
0.00%
0/260 • All Adverse Events through 3 year follow-up visit.
|
2.7%
2/73 • Number of events 2 • All Adverse Events through 3 year follow-up visit.
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.00%
0/260 • All Adverse Events through 3 year follow-up visit.
|
1.4%
1/73 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
|
General disorders
Renal Failure
|
0.00%
0/260 • All Adverse Events through 3 year follow-up visit.
|
4.1%
3/73 • Number of events 3 • All Adverse Events through 3 year follow-up visit.
|
|
Blood and lymphatic system disorders
Bacteremia
|
0.00%
0/260 • All Adverse Events through 3 year follow-up visit.
|
1.4%
1/73 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.00%
0/260 • All Adverse Events through 3 year follow-up visit.
|
1.4%
1/73 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
|
Nervous system disorders
Closed Head Injury
|
0.00%
0/260 • All Adverse Events through 3 year follow-up visit.
|
1.4%
1/73 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
|
Vascular disorders
VASC Vessel Dissection
|
0.00%
0/260 • All Adverse Events through 3 year follow-up visit.
|
1.4%
1/73 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
|
Injury, poisoning and procedural complications
Fatigue/Generalized Fatigue
|
0.00%
0/260 • All Adverse Events through 3 year follow-up visit.
|
2.7%
2/73 • Number of events 2 • All Adverse Events through 3 year follow-up visit.
|
|
Injury, poisoning and procedural complications
Pain Due to a Catheter Drainage Tube
|
0.00%
0/260 • All Adverse Events through 3 year follow-up visit.
|
1.4%
1/73 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
|
Injury, poisoning and procedural complications
Vessel Stenosis
|
0.00%
0/260 • All Adverse Events through 3 year follow-up visit.
|
1.4%
1/73 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
|
Injury, poisoning and procedural complications
Weight Gain
|
0.00%
0/260 • All Adverse Events through 3 year follow-up visit.
|
1.4%
1/73 • Number of events 1 • All Adverse Events through 3 year follow-up visit.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Principal Investigators are bound by the Abbott Investigator Agreement, which includes confidentiality clauses and limits what study details and data they are permitted to share and/or publish without prior authorization from Abbott.
- Publication restrictions are in place
Restriction type: OTHER