Trial Outcomes & Findings for REPRISE IV: LOTUS Edge Valve System in Intermediate Surgical Risk Subjects (NCT NCT03618095)
NCT ID: NCT03618095
Last Updated: 2022-12-27
Results Overview
Pre-specified primary outcome measure in the protocol for the Main Cohort only. Critical safety events that are observed in the elderly population undergoing TAVR; assessments recommended by Valve Academic Research Consortium (VARC)
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
382 participants
Primary outcome timeframe
1 year post index procedure and device implantation
Results posted on
2022-12-27
Participant Flow
This study was terminated early. Enrollment was stopped before the target number of subjects were enrolled to achieve target power and was insufficient to produce statistically reliable results. All characteristics are based on the total enrollment and not the individual arms as there were not sufficient subjects. In addition, as there was not sufficient power, and even the enrolled subjects did not all reach 1 year follow-up, no primary endpoint analysis was warranted.
Participant milestones
| Measure |
Main Cohort
Transcatheter Aortic Valve Replacement (TAVR) with the LOTUS Edge Valve System
LOTUS Edge Valve System: TAVR with the LOTUS Edge Valve System
|
Roll-In Cohort
Transcatheter Aortic Valve Replacement (TAVR) with the LOTUS Edge Valve System for sites that do not have implantation experience with the LOTUS Edge Valve System. At least 2 per site needed.
LOTUS Edge Valve System: TAVR with the LOTUS Edge Valve System
|
Bicuspid Cohort
Transcatheter Aortic Valve Replacement (TAVR) with the LOTUS Edge Valve System in a native bicuspid aortic valve.
LOTUS Edge Valve System: TAVR with the LOTUS Edge Valve System
|
|---|---|---|---|
|
Overall Study
STARTED
|
274
|
63
|
45
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
274
|
63
|
45
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
REPRISE IV: LOTUS Edge Valve System in Intermediate Surgical Risk Subjects
Baseline characteristics by cohort
| Measure |
Main Cohort
n=274 Participants
Transcatheter Aortic Valve Replacement (TAVR) with the LOTUS Edge Valve System
LOTUS Edge Valve System: TAVR with the LOTUS Edge Valve System
|
Roll-In Cohort
n=63 Participants
Transcatheter Aortic Valve Replacement (TAVR) with the LOTUS Edge Valve System for sites that do not have implantation experience with the LOTUS Edge Valve System. At least 2 per site needed.
LOTUS Edge Valve System: TAVR with the LOTUS Edge Valve System
|
Bicuspid Cohort
n=45 Participants
Transcatheter Aortic Valve Replacement (TAVR) with the LOTUS Edge Valve System in a native bicuspid aortic valve.
LOTUS Edge Valve System: TAVR with the LOTUS Edge Valve System
|
Total
n=382 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
77.6 years
STANDARD_DEVIATION 6.1 • n=5 Participants
|
79.8 years
STANDARD_DEVIATION 6.8 • n=7 Participants
|
74.8 years
STANDARD_DEVIATION 6.1 • n=5 Participants
|
77.7 years
STANDARD_DEVIATION 6.3 • n=4 Participants
|
|
Sex: Female, Male
Female
|
127 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
179 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
147 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
203 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black, of African heritage
|
14 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
250 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
347 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Not Disclosed
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
257 participants
n=5 Participants
|
63 participants
n=7 Participants
|
42 participants
n=5 Participants
|
362 participants
n=4 Participants
|
|
Region of Enrollment
Australia
|
17 participants
n=5 Participants
|
0 participants
n=7 Participants
|
3 participants
n=5 Participants
|
20 participants
n=4 Participants
|
|
Society of Thoracic Surgeons (STS) Risk Score
|
2.6 Percent %
STANDARD_DEVIATION 1.1 • n=5 Participants
|
3.4 Percent %
STANDARD_DEVIATION 2.1 • n=7 Participants
|
2.1 Percent %
STANDARD_DEVIATION 0.9 • n=5 Participants
|
2.7 Percent %
STANDARD_DEVIATION 1.4 • n=4 Participants
|
|
European System for Cardiac Operative Risk Evaluation (EuroSCORE)
|
2.6 Percent predicted
STANDARD_DEVIATION 1.9 • n=5 Participants
|
3.0 Percent predicted
STANDARD_DEVIATION 2.5 • n=7 Participants
|
2.4 Percent predicted
STANDARD_DEVIATION 2.1 • n=5 Participants
|
2.6 Percent predicted
STANDARD_DEVIATION 2.0 • n=4 Participants
|
PRIMARY outcome
Timeframe: 1 year post index procedure and device implantationPopulation: This study was terminated early. Enrollment was stopped before the target number of subjects were enrolled. Additionally, patient follow-up was terminated therefore, not all enrolled subjects at the time of termination were followed through the Primary Endpoint timepoint (1 Year). This analysis only represents those patients who reached 1 year at the time of study termination.
Pre-specified primary outcome measure in the protocol for the Main Cohort only. Critical safety events that are observed in the elderly population undergoing TAVR; assessments recommended by Valve Academic Research Consortium (VARC)
Outcome measures
| Measure |
Main Cohort
n=174 Participants
Transcatheter Aortic Valve Replacement (TAVR) with the LOTUS Edge Valve System
LOTUS Edge Valve System: TAVR with the LOTUS Edge Valve System
|
|---|---|
|
Composite of All-cause Mortality and All Stroke.
|
18 Participants
|
Adverse Events
Main Cohort
Serious events: 175 serious events
Other events: 176 other events
Deaths: 14 deaths
Roll-In Cohort
Serious events: 42 serious events
Other events: 34 other events
Deaths: 8 deaths
Bicuspid Cohort
Serious events: 24 serious events
Other events: 35 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Main Cohort
n=274 participants at risk
Transcatheter Aortic Valve Replacement (TAVR) with the LOTUS Edge Valve System
LOTUS Edge Valve System: TAVR with the LOTUS Edge Valve System
|
Roll-In Cohort
n=63 participants at risk
Transcatheter Aortic Valve Replacement (TAVR) with the LOTUS Edge Valve System for sites that do not have implantation experience with the LOTUS Edge Valve System. At least 2 per site needed.
LOTUS Edge Valve System: TAVR with the LOTUS Edge Valve System
|
Bicuspid Cohort
n=45 participants at risk
Transcatheter Aortic Valve Replacement (TAVR) with the LOTUS Edge Valve System in a native bicuspid aortic valve.
LOTUS Edge Valve System: TAVR with the LOTUS Edge Valve System
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.1%
3/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
1.6%
1/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Blood and lymphatic system disorders
Anaemia macrocytic
|
0.36%
1/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.36%
1/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
1.6%
1/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Blood and lymphatic system disorders
Haemorrhagic disorder
|
0.36%
1/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Blood and lymphatic system disorders
Leukaemoid reaction
|
0.36%
1/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
1.5%
4/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.8%
5/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Cardiac disorders
Accelerated idioventricular rhythm
|
0.36%
1/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Cardiac disorders
Acute left ventricular failure
|
1.1%
3/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Cardiac disorders
Acute myocardial infarction
|
1.8%
5/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
1.6%
1/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
2.2%
1/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Cardiac disorders
Angina pectoris
|
0.36%
1/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
1.6%
1/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Cardiac disorders
Angina unstable
|
0.36%
1/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Cardiac disorders
Aortic valve incompetence
|
0.00%
0/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
4.4%
2/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.36%
1/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Cardiac disorders
Atrial fibrillation
|
4.4%
12/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
7.9%
5/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
4.4%
2/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Cardiac disorders
Atrial flutter
|
0.73%
2/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
1.6%
1/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Cardiac disorders
Atrioventricular block
|
1.5%
4/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Cardiac disorders
Atrioventricular block complete
|
22.3%
61/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
27.0%
17/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
13.3%
6/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Cardiac disorders
Atrioventricular block first degree
|
1.1%
3/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
3.2%
2/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
2.2%
1/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Cardiac disorders
Atrioventricular block second degree
|
2.6%
7/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
4.4%
2/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Cardiac disorders
Bradycardia
|
1.1%
3/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Cardiac disorders
Bundle branch block left
|
13.1%
36/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
11.1%
7/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
15.6%
7/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Cardiac disorders
Cardiac arrest
|
1.5%
4/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Cardiac disorders
Cardiac failure
|
1.1%
3/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Cardiac disorders
Cardiac failure acute
|
1.1%
3/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
1.6%
1/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
2.2%
1/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Cardiac disorders
Cardiac failure congestive
|
5.5%
15/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
7.9%
5/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Cardiac disorders
Cardiac tamponade
|
0.73%
2/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
1.6%
1/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.73%
2/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
1.6%
1/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Cardiac disorders
Cardiomyopathy
|
0.73%
2/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Cardiac disorders
Chordae tendinae rupture
|
0.36%
1/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Cardiac disorders
Chronic left ventricular failure
|
0.36%
1/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Cardiac disorders
Conduction disorder
|
1.5%
4/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.73%
2/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
1.6%
1/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.36%
1/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
1.6%
1/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Cardiac disorders
Left ventricular failure
|
0.36%
1/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.36%
1/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.73%
2/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Cardiac disorders
Paravalvular aortic regurgitation
|
0.36%
1/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Cardiac disorders
Pericardial effusion
|
2.6%
7/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
1.6%
1/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Cardiac disorders
Pericarditis
|
0.36%
1/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Cardiac disorders
Prosthetic cardiac valve thrombosis
|
1.1%
3/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
1.6%
1/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
2.2%
1/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Cardiac disorders
Sinus arrest
|
0.73%
2/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Cardiac disorders
Sinus node dysfunction
|
0.73%
2/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
1.6%
1/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
2.2%
1/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.00%
0/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
2.2%
1/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.73%
2/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
1.6%
1/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Eye disorders
Blindness
|
0.36%
1/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Eye disorders
Open angle glaucoma
|
0.36%
1/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Eye disorders
Papilloedema
|
0.36%
1/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Eye disorders
Retinal infarction
|
0.36%
1/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
2.2%
1/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.36%
1/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Gastrointestinal disorders
Gastritis
|
0.36%
1/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.1%
3/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
3.2%
2/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Gastrointestinal disorders
Ileus
|
0.36%
1/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Gastrointestinal disorders
Intra-abdominal haematoma
|
0.36%
1/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.36%
1/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.36%
1/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Gastrointestinal disorders
Peritoneal haemorrhage
|
0.36%
1/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.36%
1/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.36%
1/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.36%
1/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
2.2%
1/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Gastrointestinal disorders
Vomiting
|
0.36%
1/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
General disorders
Cardiac complication associated with device
|
0.00%
0/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
2.2%
1/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
General disorders
Catheter site haematoma
|
1.1%
3/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
General disorders
Catheter site haemorrhage
|
0.73%
2/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
2.2%
1/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
General disorders
Death
|
1.1%
3/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
2.2%
1/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
General disorders
Device embolisation
|
0.36%
1/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
General disorders
Fatigue
|
0.36%
1/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
General disorders
Non-cardiac chest pain
|
0.36%
1/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
General disorders
Pyrexia
|
0.73%
2/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
2.2%
1/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
General disorders
Sudden cardiac death
|
0.00%
0/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
1.6%
1/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Hepatobiliary disorders
Jaundice
|
0.36%
1/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
1.6%
1/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Infections and infestations
Appendicitis
|
0.36%
1/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Infections and infestations
Arthritis infective
|
0.00%
0/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
2.2%
1/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Infections and infestations
Cellulitis
|
0.36%
1/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Infections and infestations
Corona virus infection
|
0.00%
0/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
1.6%
1/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Infections and infestations
Endocarditis
|
0.73%
2/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Infections and infestations
Endocarditis bacterial
|
0.00%
0/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
2.2%
1/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Infections and infestations
Enterococcal bacteraemia
|
0.36%
1/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
2.2%
1/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
1.6%
1/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Infections and infestations
Implant site infection
|
0.36%
1/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Infections and infestations
Pneumonia
|
1.5%
4/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
1.6%
1/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
2.2%
1/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Infections and infestations
Pyelonephritis
|
0.36%
1/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Infections and infestations
Sepsis
|
0.73%
2/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Infections and infestations
Septic shock
|
0.36%
1/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
1.6%
1/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Infections and infestations
Urinary tract infection
|
0.36%
1/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
3.2%
2/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.36%
1/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.00%
0/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
2.2%
1/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Injury, poisoning and procedural complications
Cardiac procedure complication
|
0.36%
1/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.36%
1/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Injury, poisoning and procedural complications
Eye injury
|
0.00%
0/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
1.6%
1/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Injury, poisoning and procedural complications
Fall
|
0.73%
2/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
3.2%
2/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
2.2%
1/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Injury, poisoning and procedural complications
Foreign body
|
0.36%
1/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.36%
1/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.36%
1/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Injury, poisoning and procedural complications
Structural valve deterioration
|
0.36%
1/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Injury, poisoning and procedural complications
Subarachnoid haemorrhage
|
0.36%
1/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.36%
1/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
1.6%
1/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
2.2%
1/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Injury, poisoning and procedural complications
Vascular procedure complication
|
0.36%
1/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
1.6%
1/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
2.2%
1/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.73%
2/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Investigations
Blood pressure systolic increased
|
0.00%
0/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
1.6%
1/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Investigations
Echocardiogram abnormal
|
0.36%
1/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Investigations
International normalised ratio increased
|
0.73%
2/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Investigations
Troponin increased
|
0.36%
1/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.73%
2/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.36%
1/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.36%
1/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.36%
1/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.73%
2/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.36%
1/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.36%
1/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
1.6%
1/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Musculoskeletal and connective tissue disorders
Chondrocalcinosis pyrophosphate
|
0.36%
1/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.36%
1/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.36%
1/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.36%
1/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
2.2%
1/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.36%
1/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
0.00%
0/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
2.2%
1/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.36%
1/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
1.6%
1/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of renal pelvis
|
0.36%
1/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.36%
1/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.36%
1/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Nervous system disorders
Alcoholic seizure
|
0.00%
0/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
1.6%
1/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Nervous system disorders
Ataxia
|
0.36%
1/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Nervous system disorders
Cerebral infarction
|
0.73%
2/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Nervous system disorders
Cerebrovascular accident
|
2.2%
6/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
4.8%
3/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
2.2%
1/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Nervous system disorders
Cubital tunnel syndrome
|
0.36%
1/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Nervous system disorders
Embolic stroke
|
0.00%
0/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
1.6%
1/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Nervous system disorders
Encephalopathy
|
0.73%
2/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
1.6%
1/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Nervous system disorders
Facial paralysis
|
0.36%
1/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Nervous system disorders
Ischaemic cerebral infarction
|
0.00%
0/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
2.2%
1/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Nervous system disorders
Ischaemic stroke
|
2.6%
7/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.36%
1/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
1.6%
1/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Nervous system disorders
Mononeuropathy
|
0.36%
1/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Nervous system disorders
Nystagmus
|
0.00%
0/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
1.6%
1/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Nervous system disorders
Presyncope
|
0.36%
1/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Nervous system disorders
Seizure
|
1.1%
3/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Nervous system disorders
Syncope
|
1.1%
3/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Nervous system disorders
Transient ischaemic attack
|
1.8%
5/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Product Issues
Device failure
|
0.73%
2/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Psychiatric disorders
Bipolar disorder
|
0.36%
1/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Psychiatric disorders
Major depression
|
0.36%
1/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Psychiatric disorders
Mental status changes
|
0.36%
1/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
1.6%
1/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Renal and urinary disorders
Acute kidney injury
|
2.6%
7/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
4.8%
3/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
4.4%
2/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Renal and urinary disorders
Bladder neck obstruction
|
0.36%
1/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Renal and urinary disorders
Bladder outlet obstruction
|
0.36%
1/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Renal and urinary disorders
Haematuria
|
0.73%
2/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.36%
1/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Renal and urinary disorders
Urinary retention
|
0.36%
1/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
1.6%
1/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Reproductive system and breast disorders
Ovarian mass
|
0.36%
1/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.1%
3/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
3.2%
2/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
2.2%
1/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.36%
1/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.1%
3/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Respiratory, thoracic and mediastinal disorders
Mediastinal haematoma
|
0.36%
1/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.36%
1/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.1%
3/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
2.2%
1/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.73%
2/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.5%
4/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
3.2%
2/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.36%
1/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Vascular disorders
Arterial haemorrhage
|
0.73%
2/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Vascular disorders
Deep vein thrombosis
|
0.73%
2/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Vascular disorders
Haematoma
|
0.36%
1/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Vascular disorders
Hypertension
|
0.36%
1/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
2.2%
1/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Vascular disorders
Hypertensive crisis
|
0.36%
1/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Vascular disorders
Hypotension
|
1.8%
5/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
1.6%
1/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Vascular disorders
Hypovolaemic shock
|
0.00%
0/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
1.6%
1/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Vascular disorders
Peripheral artery occlusion
|
0.73%
2/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
1.6%
1/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.73%
2/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
1.6%
1/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.36%
1/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Vascular disorders
Shock haemorrhagic
|
0.73%
2/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
Other adverse events
| Measure |
Main Cohort
n=274 participants at risk
Transcatheter Aortic Valve Replacement (TAVR) with the LOTUS Edge Valve System
LOTUS Edge Valve System: TAVR with the LOTUS Edge Valve System
|
Roll-In Cohort
n=63 participants at risk
Transcatheter Aortic Valve Replacement (TAVR) with the LOTUS Edge Valve System for sites that do not have implantation experience with the LOTUS Edge Valve System. At least 2 per site needed.
LOTUS Edge Valve System: TAVR with the LOTUS Edge Valve System
|
Bicuspid Cohort
n=45 participants at risk
Transcatheter Aortic Valve Replacement (TAVR) with the LOTUS Edge Valve System in a native bicuspid aortic valve.
LOTUS Edge Valve System: TAVR with the LOTUS Edge Valve System
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
0.36%
1/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
6.7%
3/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Vascular disorders
Hypotension
|
4.4%
12/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
7.9%
5/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
6.7%
3/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
2.2%
6/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
3.2%
2/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
6.7%
3/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
6.2%
17/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
4.8%
3/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
11.1%
5/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Cardiac disorders
Atrial fibrillation
|
9.1%
25/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
6.3%
4/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
13.3%
6/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Cardiac disorders
Atrioventricular block first degree
|
6.6%
18/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
4.4%
2/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Cardiac disorders
Bundle branch block left
|
32.8%
90/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
28.6%
18/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
28.9%
13/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
Gastrointestinal disorders
Nausea
|
0.73%
2/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
0.00%
0/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
6.7%
3/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
|
General disorders
Non-cardiac chest pain
|
1.8%
5/274 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
3.2%
2/63 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
6.7%
3/45 • Events collected through the Termination of the study, majority of patient an average of 30 days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A contractual agreement is in place between the PI and the Sponsor that restricts the rights to discuss or publish trial results without prior review by the sponsor.
- Publication restrictions are in place
Restriction type: OTHER