Trial Outcomes & Findings for Evaluation of VISITAG SURPOINT™ Module With External Processing Unit (EPU) (NCT NCT03624881)
NCT ID: NCT03624881
Last Updated: 2023-07-03
Results Overview
A PAE is a serious adverse event (SAEs), which occurred within the first week (7 days) following an atrial fibrillation (AF) ablation procedure with use of Tag Index. Pulmonary vein (PV) stenosis and atrio-esophageal fistula that occurred greater than one week (7 days) post-procedure were deemed Primary AEs. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
333 participants
Primary outcome timeframe
Up to 12 months
Results posted on
2023-07-03
Participant Flow
Participant milestones
| Measure |
VISITAG SURPOINT Module STSF Catheter With EPU
Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were treated with electrophysiology mapping and radiofrequency (RF) ablation using VISITAG SURPOINT module with THERMOCOOL SMARTTOUCH Surround Flow (STSF) catheter with external processing unit (EPU).
|
VISITAG SURPOINT Module ST Catheter With EPU
Participants with symptomatic PAF who have failed at least one antiarrhythmic drug, were treated with electrophysiology mapping and radiofrequency (RF) ablation using VISITAG SURPOINT module with THERMOCOOL SMARTTOUCH (ST) catheter with EPU.
|
|---|---|---|
|
Overall Study
STARTED
|
283
|
50
|
|
Overall Study
Safety Set
|
261
|
49
|
|
Overall Study
COMPLETED
|
237
|
44
|
|
Overall Study
NOT COMPLETED
|
46
|
6
|
Reasons for withdrawal
| Measure |
VISITAG SURPOINT Module STSF Catheter With EPU
Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were treated with electrophysiology mapping and radiofrequency (RF) ablation using VISITAG SURPOINT module with THERMOCOOL SMARTTOUCH Surround Flow (STSF) catheter with external processing unit (EPU).
|
VISITAG SURPOINT Module ST Catheter With EPU
Participants with symptomatic PAF who have failed at least one antiarrhythmic drug, were treated with electrophysiology mapping and radiofrequency (RF) ablation using VISITAG SURPOINT module with THERMOCOOL SMARTTOUCH (ST) catheter with EPU.
|
|---|---|---|
|
Overall Study
Screen Failure
|
14
|
0
|
|
Overall Study
No Catheter Inserted
|
6
|
1
|
|
Overall Study
Catheter Inserted and RF Energy Delivery with No EPU System Used
|
2
|
0
|
|
Overall Study
Death
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
10
|
4
|
|
Overall Study
Withdrawal by Subject
|
12
|
1
|
Baseline Characteristics
Evaluation of VISITAG SURPOINT™ Module With External Processing Unit (EPU)
Baseline characteristics by cohort
| Measure |
VISITAG SURPOINT Module STSF Catheter With EPU
n=261 Participants
Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were treated with electrophysiology mapping and radiofrequency (RF) ablation using VISITAG SURPOINT module with THERMOCOOL SMARTTOUCH Surround Flow (STSF) catheter with external processing unit (EPU).
|
VISITAG SURPOINT Module ST Catheter With EPU
n=49 Participants
Participants with symptomatic PAF who have failed at least one antiarrhythmic drug, were treated with electrophysiology mapping and radiofrequency (RF) ablation using VISITAG SURPOINT module with THERMOCOOL SMARTTOUCH (ST) catheter with EPU.
|
Total
n=310 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.1 years
STANDARD_DEVIATION 10.53 • n=5 Participants
|
62.7 years
STANDARD_DEVIATION 9.97 • n=7 Participants
|
63.4 years
STANDARD_DEVIATION 10.25 • n=5 Participants
|
|
Sex: Female, Male
Female
|
109 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
136 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
152 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
174 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
16 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
231 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
267 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
14 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
221 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
258 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
|
24 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 12 monthsPopulation: The safety set consisted of all enrolled participants who had undergone insertion of the STSF or ST catheter and use of the VISITAG SURPOINT module with EPU. Here 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure.
A PAE is a serious adverse event (SAEs), which occurred within the first week (7 days) following an atrial fibrillation (AF) ablation procedure with use of Tag Index. Pulmonary vein (PV) stenosis and atrio-esophageal fistula that occurred greater than one week (7 days) post-procedure were deemed Primary AEs. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.
Outcome measures
| Measure |
VISITAG SURPOINT Module STSF Catheter With EPU
n=261 Participants
Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were treated with electrophysiology mapping and radiofrequency (RF) ablation using VISITAG SURPOINT module with THERMOCOOL SMARTTOUCH Surround Flow (STSF) catheter with external processing unit (EPU).
|
VISITAG SURPOINT Module ST Catheter With EPU
n=48 Participants
Participants with symptomatic PAF who have failed at least one antiarrhythmic drug, were treated with electrophysiology mapping and radiofrequency (RF) ablation using VISITAG SURPOINT module with THERMOCOOL SMARTTOUCH (ST) catheter with EPU.
|
|---|---|---|
|
Number of Participants With Primary Adverse Events (PAEs)
|
11 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Up to 12 monthsPopulation: The Per-protocol (PP) set consisted of all enrolled participants who had undergone RF ablation and were treated with the STSF or ST catheters with the VISITAG SURPOINT Module with EPU, and had been treated for the study-related arrhythmia. Here 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure.
Number of participants free from symptomatic and asymptomatic atrial tachyarrhythmias (which includes atrial fibrillation \[AF\], atrial flutter \[AFL\], and atrial tachycardia \[AT\]) were reported.
Outcome measures
| Measure |
VISITAG SURPOINT Module STSF Catheter With EPU
n=228 Participants
Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were treated with electrophysiology mapping and radiofrequency (RF) ablation using VISITAG SURPOINT module with THERMOCOOL SMARTTOUCH Surround Flow (STSF) catheter with external processing unit (EPU).
|
VISITAG SURPOINT Module ST Catheter With EPU
n=44 Participants
Participants with symptomatic PAF who have failed at least one antiarrhythmic drug, were treated with electrophysiology mapping and radiofrequency (RF) ablation using VISITAG SURPOINT module with THERMOCOOL SMARTTOUCH (ST) catheter with EPU.
|
|---|---|---|
|
Number of Participants Free From Atrial Tachyarrhythmias (Symptomatic and Asymptomatic)
|
173 Participants
|
34 Participants
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: The safety set consisted of all enrolled participants who had undergone insertion of the STSF or ST catheter and use of the VISITAG SURPOINT module with EPU.
A PAE is a serious adverse event, which occurs within the first week (7 days) following an AF ablation procedure with use of Tag Index. Pulmonary vein (PV) stenosis and atrio-esophageal fistula that occurs greater than one week (7 days) post-procedure were deemed Primary AEs. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.
Outcome measures
| Measure |
VISITAG SURPOINT Module STSF Catheter With EPU
n=261 Participants
Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were treated with electrophysiology mapping and radiofrequency (RF) ablation using VISITAG SURPOINT module with THERMOCOOL SMARTTOUCH Surround Flow (STSF) catheter with external processing unit (EPU).
|
VISITAG SURPOINT Module ST Catheter With EPU
n=49 Participants
Participants with symptomatic PAF who have failed at least one antiarrhythmic drug, were treated with electrophysiology mapping and radiofrequency (RF) ablation using VISITAG SURPOINT module with THERMOCOOL SMARTTOUCH (ST) catheter with EPU.
|
|---|---|---|
|
Percentage of Participants With Cumulative PAEs
|
4.3 Percentage of Participants
|
6.3 Percentage of Participants
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: The safety set consisted of all enrolled participants who had undergone insertion of the STSF or ST catheter and use of the VISITAG SURPOINT module with EPU.
Number of participants with UADEs was reported.
Outcome measures
| Measure |
VISITAG SURPOINT Module STSF Catheter With EPU
n=261 Participants
Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were treated with electrophysiology mapping and radiofrequency (RF) ablation using VISITAG SURPOINT module with THERMOCOOL SMARTTOUCH Surround Flow (STSF) catheter with external processing unit (EPU).
|
VISITAG SURPOINT Module ST Catheter With EPU
n=49 Participants
Participants with symptomatic PAF who have failed at least one antiarrhythmic drug, were treated with electrophysiology mapping and radiofrequency (RF) ablation using VISITAG SURPOINT module with THERMOCOOL SMARTTOUCH (ST) catheter with EPU.
|
|---|---|---|
|
Number of Participants With Unanticipated Adverse Device Effects (UADEs)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: The safety set consisted of all enrolled participants who had undergone insertion of the STSF or ST catheter and use of the VISITAG SURPOINT module with EPU.
Serious non-primary adverse events were defined as serious AEs (SAEs) that are not primary adverse events. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.
Outcome measures
| Measure |
VISITAG SURPOINT Module STSF Catheter With EPU
n=261 Participants
Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were treated with electrophysiology mapping and radiofrequency (RF) ablation using VISITAG SURPOINT module with THERMOCOOL SMARTTOUCH Surround Flow (STSF) catheter with external processing unit (EPU).
|
VISITAG SURPOINT Module ST Catheter With EPU
n=49 Participants
Participants with symptomatic PAF who have failed at least one antiarrhythmic drug, were treated with electrophysiology mapping and radiofrequency (RF) ablation using VISITAG SURPOINT module with THERMOCOOL SMARTTOUCH (ST) catheter with EPU.
|
|---|---|---|
|
Number of Participants With Serious Non-Primary AEs
|
42 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Within 7 Days (Early Onset), 8-30 Days (Peri-procedural) and >=31 Days (Late Onset) of Initial Ablation Procedure (Up to 12 Months)Population: The safety set consisted of all enrolled participants who had undergone insertion of the STSF or ST catheter and use of the VISITAG SURPOINT module with EPU. Here 'n' (number analyzed) signifies the number of participants analyzed at specified timepoints.
Number of participants with bleeding complication by ISTH class and timing of onset were reported. The ISTH classification of major bleeding event is a hemoglobin drop of greater than or equal to (\>=) 2 grams per deciliter (g/dL), transfusion of \>= 2 units (U) packed red blood cells, symptomatic bleed in a critical area, or fatal bleed. Clinically relevant non-major (CRNM) events require prolong hospitalization or result in laboratory testing, imaging, compression, procedure, interruption of the study medication or a change in concomitant therapy. Minor bleeding events are overt bleeding events that do not meet the criteria for CRNM or major bleeding events.
Outcome measures
| Measure |
VISITAG SURPOINT Module STSF Catheter With EPU
n=261 Participants
Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were treated with electrophysiology mapping and radiofrequency (RF) ablation using VISITAG SURPOINT module with THERMOCOOL SMARTTOUCH Surround Flow (STSF) catheter with external processing unit (EPU).
|
VISITAG SURPOINT Module ST Catheter With EPU
n=49 Participants
Participants with symptomatic PAF who have failed at least one antiarrhythmic drug, were treated with electrophysiology mapping and radiofrequency (RF) ablation using VISITAG SURPOINT module with THERMOCOOL SMARTTOUCH (ST) catheter with EPU.
|
|---|---|---|
|
Number of Participants With Bleeding Complication by International Society on Thrombosis and Haemostasis (ISTH) Class and Timing of Onset
Major (0-7 Days)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Bleeding Complication by International Society on Thrombosis and Haemostasis (ISTH) Class and Timing of Onset
Major (8-30 Days)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Bleeding Complication by International Society on Thrombosis and Haemostasis (ISTH) Class and Timing of Onset
Major (>=31 Days)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Bleeding Complication by International Society on Thrombosis and Haemostasis (ISTH) Class and Timing of Onset
CRNM (0-7 Days)
|
4 Participants
|
0 Participants
|
|
Number of Participants With Bleeding Complication by International Society on Thrombosis and Haemostasis (ISTH) Class and Timing of Onset
CRNM (8-30 Days)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Bleeding Complication by International Society on Thrombosis and Haemostasis (ISTH) Class and Timing of Onset
CRNM (>=31 Days)
|
3 Participants
|
0 Participants
|
|
Number of Participants With Bleeding Complication by International Society on Thrombosis and Haemostasis (ISTH) Class and Timing of Onset
Minor (0-7 Days)
|
17 Participants
|
1 Participants
|
|
Number of Participants With Bleeding Complication by International Society on Thrombosis and Haemostasis (ISTH) Class and Timing of Onset
Minor (8-30 Days)
|
2 Participants
|
0 Participants
|
|
Number of Participants With Bleeding Complication by International Society on Thrombosis and Haemostasis (ISTH) Class and Timing of Onset
Minor (>=31 Days)
|
7 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: End of the Procedure (up to 12 months)Population: The PP set consisted of all enrolled participants who had undergone RF ablation and were treated with the STSF or ST catheters with the VISITAG SURPOINT Module with EPU, and had been treated for the study-related arrhythmia.
Percentage of participants with ipsilateral PVI (entrance block) at the end of the procedure were reported.
Outcome measures
| Measure |
VISITAG SURPOINT Module STSF Catheter With EPU
n=246 Participants
Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were treated with electrophysiology mapping and radiofrequency (RF) ablation using VISITAG SURPOINT module with THERMOCOOL SMARTTOUCH Surround Flow (STSF) catheter with external processing unit (EPU).
|
VISITAG SURPOINT Module ST Catheter With EPU
n=49 Participants
Participants with symptomatic PAF who have failed at least one antiarrhythmic drug, were treated with electrophysiology mapping and radiofrequency (RF) ablation using VISITAG SURPOINT module with THERMOCOOL SMARTTOUCH (ST) catheter with EPU.
|
|---|---|---|
|
Percentage of Participants With Ipsilateral Pulmonary Vein Isolation (PVI) (Entrance Block) at the End of the Procedure
|
98.8 Percentage of Participants
|
100 Percentage of Participants
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: The PP set consisted of all enrolled participants who had undergone RF ablation and were treated with the STSF or ST catheters with the VISITAG SURPOINT Module with EPU, and had been treated for the study-related arrhythmia.
Percentage of participants with ipsilateral PVI after first encirclement without Acute reconnection was reported.
Outcome measures
| Measure |
VISITAG SURPOINT Module STSF Catheter With EPU
n=246 Participants
Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were treated with electrophysiology mapping and radiofrequency (RF) ablation using VISITAG SURPOINT module with THERMOCOOL SMARTTOUCH Surround Flow (STSF) catheter with external processing unit (EPU).
|
VISITAG SURPOINT Module ST Catheter With EPU
n=49 Participants
Participants with symptomatic PAF who have failed at least one antiarrhythmic drug, were treated with electrophysiology mapping and radiofrequency (RF) ablation using VISITAG SURPOINT module with THERMOCOOL SMARTTOUCH (ST) catheter with EPU.
|
|---|---|---|
|
Percentage of Participants With Ipsilateral PVI After First Encirclement Without Acute Reconnection
|
72.0 Percentage of Participants
|
85.7 Percentage of Participants
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: The PP set consisted of all enrolled participants who had undergone RF ablation and were treated with the STSF or ST catheters with the VISITAG SURPOINT Module with EPU, and had been treated for the study-related arrhythmia.
Percentage of targeted veins with touch-up (ablation of acute reconnection) among all targeted veins was reported.
Outcome measures
| Measure |
VISITAG SURPOINT Module STSF Catheter With EPU
n=492 Targeted Veins
Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were treated with electrophysiology mapping and radiofrequency (RF) ablation using VISITAG SURPOINT module with THERMOCOOL SMARTTOUCH Surround Flow (STSF) catheter with external processing unit (EPU).
|
VISITAG SURPOINT Module ST Catheter With EPU
n=98 Targeted Veins
Participants with symptomatic PAF who have failed at least one antiarrhythmic drug, were treated with electrophysiology mapping and radiofrequency (RF) ablation using VISITAG SURPOINT module with THERMOCOOL SMARTTOUCH (ST) catheter with EPU.
|
|---|---|---|
|
Percentage of Targeted Veins With Touch-up (Ablation of Acute Reconnection) Among All Targeted Veins
|
16.9 Percentage of targeted veins
|
7.1 Percentage of targeted veins
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: The PP set consisted of all enrolled participants who had undergone RF ablation and were treated with the STSF or ST catheters with the VISITAG SURPOINT Module with EPU, and had been treated for the study-related arrhythmia. Here 'n' (number of targeted veins analyzed) included all evaluable numbers of targeted veins which were analyzed at specified categories.
Percentage of targeted veins with touch-up at anatomical location of acute PV reconnection after first encirclement was reported. The location included anterior, superior, ridge, posterior, and inferior region of the left pulmonary veins (LPV) and right pulmonary veins (RPV).
Outcome measures
| Measure |
VISITAG SURPOINT Module STSF Catheter With EPU
n=242 Targeted Veins
Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were treated with electrophysiology mapping and radiofrequency (RF) ablation using VISITAG SURPOINT module with THERMOCOOL SMARTTOUCH Surround Flow (STSF) catheter with external processing unit (EPU).
|
VISITAG SURPOINT Module ST Catheter With EPU
n=49 Targeted Veins
Participants with symptomatic PAF who have failed at least one antiarrhythmic drug, were treated with electrophysiology mapping and radiofrequency (RF) ablation using VISITAG SURPOINT module with THERMOCOOL SMARTTOUCH (ST) catheter with EPU.
|
|---|---|---|
|
Percentage of Targeted Veins With Touch-up at Anatomical Location of Acute PV Reconnection After First Encirclement
LPV: Anterior
|
4.2 Percentage of targeted veins
|
2.4 Percentage of targeted veins
|
|
Percentage of Targeted Veins With Touch-up at Anatomical Location of Acute PV Reconnection After First Encirclement
LPV: Superior
|
3.5 Percentage of targeted veins
|
0.0 Percentage of targeted veins
|
|
Percentage of Targeted Veins With Touch-up at Anatomical Location of Acute PV Reconnection After First Encirclement
LPV: Ridge
|
3.9 Percentage of targeted veins
|
0.0 Percentage of targeted veins
|
|
Percentage of Targeted Veins With Touch-up at Anatomical Location of Acute PV Reconnection After First Encirclement
LPV: Posterior
|
7.5 Percentage of targeted veins
|
0.0 Percentage of targeted veins
|
|
Percentage of Targeted Veins With Touch-up at Anatomical Location of Acute PV Reconnection After First Encirclement
LPV: Inferior
|
1.3 Percentage of targeted veins
|
2.2 Percentage of targeted veins
|
|
Percentage of Targeted Veins With Touch-up at Anatomical Location of Acute PV Reconnection After First Encirclement
RPV: Anterior
|
11.6 Percentage of targeted veins
|
4.3 Percentage of targeted veins
|
|
Percentage of Targeted Veins With Touch-up at Anatomical Location of Acute PV Reconnection After First Encirclement
RPV: Superior
|
5.7 Percentage of targeted veins
|
12.5 Percentage of targeted veins
|
|
Percentage of Targeted Veins With Touch-up at Anatomical Location of Acute PV Reconnection After First Encirclement
RPV: Ridge
|
9.1 Percentage of targeted veins
|
0.0 Percentage of targeted veins
|
|
Percentage of Targeted Veins With Touch-up at Anatomical Location of Acute PV Reconnection After First Encirclement
RPV: Posterior
|
13.3 Percentage of targeted veins
|
6.1 Percentage of targeted veins
|
|
Percentage of Targeted Veins With Touch-up at Anatomical Location of Acute PV Reconnection After First Encirclement
RPV: Inferior
|
6.3 Percentage of targeted veins
|
0.0 Percentage of targeted veins
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: The PP set consisted of all enrolled participants who had undergone RF ablation and were treated with the STSF or ST catheters with the VISITAG SURPOINT Module with EPU, and had been treated for the study-related arrhythmia.
Number of participants who underwent repeat ablation procedures were reported.
Outcome measures
| Measure |
VISITAG SURPOINT Module STSF Catheter With EPU
n=246 Participants
Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were treated with electrophysiology mapping and radiofrequency (RF) ablation using VISITAG SURPOINT module with THERMOCOOL SMARTTOUCH Surround Flow (STSF) catheter with external processing unit (EPU).
|
VISITAG SURPOINT Module ST Catheter With EPU
n=49 Participants
Participants with symptomatic PAF who have failed at least one antiarrhythmic drug, were treated with electrophysiology mapping and radiofrequency (RF) ablation using VISITAG SURPOINT module with THERMOCOOL SMARTTOUCH (ST) catheter with EPU.
|
|---|---|---|
|
Number of Participants Who Underwent Repeat Ablation Procedures
|
14 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: The PP set consisted of all enrolled participants who had undergone RF ablation and were treated with the STSF or ST catheters with the VISITAG SURPOINT Module with EPU, and had been treated for the study-related arrhythmia. Here 'N' (number of participants analyzed) signifies the number of participants analyzed in this outcome measure.
Percentage of participants with PVs re-isolation among all of the targeted PVs at repeat procedure was reported.
Outcome measures
| Measure |
VISITAG SURPOINT Module STSF Catheter With EPU
n=14 Participants
Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were treated with electrophysiology mapping and radiofrequency (RF) ablation using VISITAG SURPOINT module with THERMOCOOL SMARTTOUCH Surround Flow (STSF) catheter with external processing unit (EPU).
|
VISITAG SURPOINT Module ST Catheter With EPU
n=3 Participants
Participants with symptomatic PAF who have failed at least one antiarrhythmic drug, were treated with electrophysiology mapping and radiofrequency (RF) ablation using VISITAG SURPOINT module with THERMOCOOL SMARTTOUCH (ST) catheter with EPU.
|
|---|---|---|
|
Percentage of Participants With PVs Re-isolation Among All of the Targeted PVs at Repeat Procedure
|
57.1 Percentage of Participants
|
100 Percentage of Participants
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: The PP set consisted of all enrolled participants who had undergone RF ablation and were treated with the STSF or ST catheters with the VISITAG SURPOINT Module with EPU, and had been treated for the study-related arrhythmia. Here 'N' (number of participants analyzed) signifies the number of participants analyzed in this outcome measure.
Percentage of participants requiring new linear lesion and/or new foci identified during the repeat ablation procedure was reported.
Outcome measures
| Measure |
VISITAG SURPOINT Module STSF Catheter With EPU
n=14 Participants
Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were treated with electrophysiology mapping and radiofrequency (RF) ablation using VISITAG SURPOINT module with THERMOCOOL SMARTTOUCH Surround Flow (STSF) catheter with external processing unit (EPU).
|
VISITAG SURPOINT Module ST Catheter With EPU
n=3 Participants
Participants with symptomatic PAF who have failed at least one antiarrhythmic drug, were treated with electrophysiology mapping and radiofrequency (RF) ablation using VISITAG SURPOINT module with THERMOCOOL SMARTTOUCH (ST) catheter with EPU.
|
|---|---|---|
|
Percentage of Participants Requiring New Linear Lesion and/or New Foci Identified During the Repeat Ablation Procedure
|
64.3 Percentage of Participants
|
66.7 Percentage of Participants
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: The PP set consisted of all enrolled participants who had undergone RF ablation and were treated with the STSF or ST catheters with the VISITAG SURPOINT Module with EPU, and had been treated for the study-related arrhythmia. Here 'N' (number of participants analyzed) signifies the number of participants analyzed in this outcome measure.
Percentage of participants with 12-month single procedure success was reported. It is defined as freedom from 1) any repeat procedure for Atrial fibrillation (AF)/Atrial tachycardia (AT)/Atrial flutter (AFL) post index procedure; 2) any class I/III AAD taking during the evaluation period; 3) documented AF/AT/AFL recurrence in evaluation period.
Outcome measures
| Measure |
VISITAG SURPOINT Module STSF Catheter With EPU
n=236 Participants
Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were treated with electrophysiology mapping and radiofrequency (RF) ablation using VISITAG SURPOINT module with THERMOCOOL SMARTTOUCH Surround Flow (STSF) catheter with external processing unit (EPU).
|
VISITAG SURPOINT Module ST Catheter With EPU
n=46 Participants
Participants with symptomatic PAF who have failed at least one antiarrhythmic drug, were treated with electrophysiology mapping and radiofrequency (RF) ablation using VISITAG SURPOINT module with THERMOCOOL SMARTTOUCH (ST) catheter with EPU.
|
|---|---|---|
|
Percentage of Participants With 12-Month Single Procedure Success
|
55.5 Percentage of Participants
|
50.0 Percentage of Participants
|
Adverse Events
VISITAG SURPOINT Module STSF Catheter With EPU
Serious events: 53 serious events
Other events: 139 other events
Deaths: 2 deaths
VISITAG SURPOINT Module ST Catheter With EPU
Serious events: 6 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
VISITAG SURPOINT Module STSF Catheter With EPU
n=261 participants at risk
Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were treated with electrophysiology mapping and radiofrequency (RF) ablation using VISITAG SURPOINT module with THERMOCOOL SMARTTOUCH Surround Flow (STSF) catheter with external processing unit (EPU).
|
VISITAG SURPOINT Module ST Catheter With EPU
n=49 participants at risk
Participants with symptomatic PAF who have failed at least one antiarrhythmic drug, were treated with electrophysiology mapping and radiofrequency (RF) ablation using VISITAG SURPOINT module with THERMOCOOL SMARTTOUCH (ST) catheter with EPU.
|
|---|---|---|
|
Cardiac disorders
Cardiac failure
|
1.5%
4/261 • Number of events 4 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Blood and lymphatic system disorders
Anaemia
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Cardiac disorders
Angina pectoris
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Cardiac disorders
Atrial fibrillation
|
1.5%
4/261 • Number of events 4 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
4.1%
2/49 • Number of events 4 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Cardiac disorders
Atrial flutter
|
2.3%
6/261 • Number of events 10 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
4.1%
2/49 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Cardiac disorders
Bradycardia
|
1.5%
4/261 • Number of events 4 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
—
0/0 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Cardiac disorders
Cardiac failure congestive
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Cardiac disorders
Coronary artery disease
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Cardiac disorders
Intracardiac thrombus
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Cardiac disorders
Mitral valve incompetence
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Cardiac disorders
Palpitations
|
1.5%
4/261 • Number of events 4 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Cardiac disorders
Pericarditis
|
2.3%
6/261 • Number of events 7 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
2.0%
1/49 • Number of events 1 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Cardiac disorders
Ventricular tachycardia
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.5%
4/261 • Number of events 4 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Gastrointestinal disorders
Dysphagia
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Gastrointestinal disorders
Gastrointestinal angiectasia
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Gastrointestinal disorders
Nausea
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
General disorders
Chest pain
|
1.5%
4/261 • Number of events 4 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
General disorders
Sudden cardiac death
|
0.38%
1/261 • Number of events 1 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Infections and infestations
Bronchitis
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Infections and infestations
Gastroenteritis
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Infections and infestations
Pneumonia
|
3.8%
10/261 • Number of events 10 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Infections and infestations
Sepsis
|
1.5%
4/261 • Number of events 4 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Infections and infestations
Urinary tract infection
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Infections and infestations
Urosepsis
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
1.5%
4/261 • Number of events 4 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/261 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
4.1%
2/49 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/261 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
4.1%
2/49 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/261 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
4.1%
2/49 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Investigations
Electroencephalogram abnormal
|
0.00%
0/261 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
4.1%
2/49 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.5%
4/261 • Number of events 4 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
2.3%
6/261 • Number of events 6 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis stenosans
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Nervous system disorders
Carotid arteriosclerosis
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Nervous system disorders
Dizziness
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Renal and urinary disorders
Acute kidney injury
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Renal and urinary disorders
Haematuria
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/261 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
4.1%
2/49 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.5%
4/261 • Number of events 4 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.1%
3/261 • Number of events 6 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.77%
2/261 • Number of events 4 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Respiratory, thoracic and mediastinal disorders
Tracheomalacia
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/261 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
4.1%
2/49 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Vascular disorders
Haematoma
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Vascular disorders
Haemorrhage
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Vascular disorders
Hypotension
|
1.5%
4/261 • Number of events 4 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Vascular disorders
Peripheral venous disease
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Nervous system disorders
Death
|
0.38%
1/261 • Number of events 1 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Cardiac disorders
Cardiac Tamponade/Perforation
|
1.1%
3/261 • Number of events 4 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Nervous system disorders
Stroke/Cerebrovascular Accident (CVA)
|
0.38%
1/261 • Number of events 1 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
4.1%
2/49 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Vascular disorders
Major Vascular Access Complication / Bleeding
|
1.1%
3/261 • Number of events 3 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
Other adverse events
| Measure |
VISITAG SURPOINT Module STSF Catheter With EPU
n=261 participants at risk
Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were treated with electrophysiology mapping and radiofrequency (RF) ablation using VISITAG SURPOINT module with THERMOCOOL SMARTTOUCH Surround Flow (STSF) catheter with external processing unit (EPU).
|
VISITAG SURPOINT Module ST Catheter With EPU
n=49 participants at risk
Participants with symptomatic PAF who have failed at least one antiarrhythmic drug, were treated with electrophysiology mapping and radiofrequency (RF) ablation using VISITAG SURPOINT module with THERMOCOOL SMARTTOUCH (ST) catheter with EPU.
|
|---|---|---|
|
Cardiac disorders
Ventricular extrasystoles
|
2.3%
6/261 • Number of events 6 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Cardiac disorders
Tachycardia
|
1.5%
4/261 • Number of events 4 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Cardiac disorders
Supraventricular tachycardia
|
4.6%
12/261 • Number of events 12 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Immune system disorders
Drug hypersensitivity
|
1.5%
4/261 • Number of events 4 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Blood and lymphatic system disorders
Anemia
|
2.3%
6/261 • Number of events 6 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Blood and lymphatic system disorders
Spontaneous haematoma
|
0.00%
0/261 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
4.1%
2/49 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Cardiac disorders
Arrhythmia
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Cardiac disorders
Atrial fibrillation
|
3.8%
10/261 • Number of events 10 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
4.1%
2/49 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Cardiac disorders
Atrial flutter
|
5.4%
14/261 • Number of events 14 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
8.2%
4/49 • Number of events 4 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Cardiac disorders
Atrial tachycardia
|
3.1%
8/261 • Number of events 8 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Cardiac disorders
Atrioventricular block
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Cardiac disorders
Bradycardia
|
1.5%
4/261 • Number of events 4 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
4.1%
2/49 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Cardiac disorders
Bundle branch block
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Cardiac disorders
Cardiac failure acute
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Cardiac disorders
Cardiac failure congestive
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Cardiac disorders
Mitral valve stenosis
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Cardiac disorders
Palpitations
|
5.4%
14/261 • Number of events 14 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
8.2%
4/49 • Number of events 4 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Cardiac disorders
Pericarditis
|
3.1%
8/261 • Number of events 8 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
4.1%
2/49 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Cardiac disorders
Sinus bradycardia
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Cardiac disorders
Sinus tachycardia
|
1.5%
4/261 • Number of events 6 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Cardiac disorders
Supraventricular extrasystoles
|
2.3%
6/261 • Number of events 6 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Cardiac disorders
Tachyarrhythmia
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Cardiac disorders
Ventricular tachycardia
|
1.5%
4/261 • Number of events 4 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
4.1%
2/49 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Cardiac disorders
Intracardiac mass
|
0.00%
0/261 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
4.1%
2/49 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/261 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
4.1%
2/49 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Congenital, familial and genetic disorders
Dermoid cyst
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Endocrine disorders
Hyperthyroidism
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Endocrine disorders
Thyroid mass
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Eye disorders
Cataract
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Eye disorders
Eye pain
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Eye disorders
Vision blurred
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
4.1%
2/49 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Eye disorders
Visual impairment
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
8.2%
4/49 • Number of events 4 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Eye disorders
Vitreous floaters
|
1.5%
4/261 • Number of events 4 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Gastrointestinal disorders
Abdominal distension
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Gastrointestinal disorders
Diarrhoea
|
4.6%
12/261 • Number of events 12 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Gastrointestinal disorders
Dyspepsia
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Gastrointestinal disorders
Large intestine polyp
|
1.5%
4/261 • Number of events 4 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Gastrointestinal disorders
Melaena
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Gastrointestinal disorders
Nausea
|
2.3%
6/261 • Number of events 6 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Gastrointestinal disorders
Periodontal disease
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
1.5%
4/261 • Number of events 4 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/261 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
4.1%
2/49 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
General disorders
Application site laceration
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
General disorders
Asthenia
|
1.5%
4/261 • Number of events 4 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
General disorders
Chest discomfort
|
3.1%
8/261 • Number of events 8 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
8.2%
4/49 • Number of events 4 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
General disorders
Chest pain
|
11.9%
31/261 • Number of events 34 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
2.0%
1/49 • Number of events 1 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
General disorders
Fatigue
|
3.8%
10/261 • Number of events 10 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
4.1%
2/49 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
General disorders
Local swelling
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
General disorders
Oedema
|
1.5%
4/261 • Number of events 4 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
General disorders
Peripheral swelling
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
4.1%
2/49 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
General disorders
Pyrexia
|
2.3%
6/261 • Number of events 6 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
General disorders
Oedema peripheral
|
4.6%
12/261 • Number of events 12 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Immune system disorders
Hypersensitivity
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Infections and infestations
Acute sinusitis
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
4.1%
2/49 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Infections and infestations
Bronchitis
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Infections and infestations
Conjunctivitis
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Infections and infestations
Conjunctivitis viral
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Infections and infestations
Corona virus infection
|
2.3%
6/261 • Number of events 6 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
4.1%
2/49 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Infections and infestations
Gastroenteritis
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Infections and infestations
Gastroenteritis viral
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Infections and infestations
Gingivitis
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Infections and infestations
Localised infection
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Infections and infestations
Medical device site infection
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Infections and infestations
Pneumonia
|
3.1%
8/261 • Number of events 12 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
4.1%
2/49 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Infections and infestations
Skin infection
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Infections and infestations
Tooth abscess
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Infections and infestations
Urinary tract infection
|
3.8%
10/261 • Number of events 10 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
4.1%
2/49 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Infections and infestations
Viral upper respiratory tract infection
|
1.5%
4/261 • Number of events 4 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/261 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
4.1%
2/49 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Injury, poisoning and procedural complications
Contusion
|
3.8%
10/261 • Number of events 10 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Injury, poisoning and procedural complications
Laceration
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Injury, poisoning and procedural complications
Nail avulsion
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Injury, poisoning and procedural complications
Scapula fracture
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Injury, poisoning and procedural complications
Vascular access site bruising
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Injury, poisoning and procedural complications
Vascular access site swelling
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Injury, poisoning and procedural complications
Wound secretion
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/261 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
4.1%
2/49 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Investigations
Blood creatinine increased
|
0.00%
0/261 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
4.1%
2/49 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Investigations
Blood sodium decreased
|
0.00%
0/261 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
4.1%
2/49 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Investigations
Heart rate increased
|
0.00%
0/261 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
8.2%
4/49 • Number of events 4 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Investigations
Weight increased
|
0.00%
0/261 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
8.2%
4/49 • Number of events 4 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Investigations
Blood uric acid increased
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Investigations
Blood cholesterol increased
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Investigations
C-reactive protein increased
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Metabolism and nutrition disorders
Fluid overload
|
1.5%
4/261 • Number of events 4 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Metabolism and nutrition disorders
Gout
|
1.5%
4/261 • Number of events 4 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/261 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
4.1%
2/49 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.3%
6/261 • Number of events 6 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
1.5%
4/261 • Number of events 4 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
1.5%
4/261 • Number of events 4 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
2.3%
6/261 • Number of events 6 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
2.3%
6/261 • Number of events 6 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Musculoskeletal and connective tissue disorders
Osteolysis
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.3%
6/261 • Number of events 6 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
4.1%
2/49 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.00%
0/261 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
4.1%
2/49 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer recurrent
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer recurrent
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Nervous system disorders
Carotid arteriosclerosis
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Nervous system disorders
Dizziness
|
5.4%
14/261 • Number of events 14 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Nervous system disorders
Headache
|
5.4%
14/261 • Number of events 14 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Nervous system disorders
Migraine with aura
|
1.5%
4/261 • Number of events 4 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
4.1%
2/49 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Nervous system disorders
Presyncope
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
4.1%
2/49 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Nervous system disorders
Sciatica
|
1.5%
4/261 • Number of events 4 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Nervous system disorders
Syncope
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
8.2%
4/49 • Number of events 4 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Nervous system disorders
Vestibular migraine
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Nervous system disorders
Migraine
|
0.00%
0/261 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
4.1%
2/49 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/261 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
4.1%
2/49 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Psychiatric disorders
Anxiety
|
1.5%
4/261 • Number of events 4 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
4.1%
2/49 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Psychiatric disorders
Depression
|
1.5%
4/261 • Number of events 4 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Psychiatric disorders
Mental status changes
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Renal and urinary disorders
Acute kidney injury
|
1.5%
4/261 • Number of events 4 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Renal and urinary disorders
Dysuria
|
1.5%
4/261 • Number of events 6 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Renal and urinary disorders
Haematuria
|
1.5%
4/261 • Number of events 4 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Renal and urinary disorders
Hydronephrosis
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/40 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Renal and urinary disorders
Renal pain
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Renal and urinary disorders
Urinary retention
|
2.3%
6/261 • Number of events 6 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Renal and urinary disorders
Dysuria, Pollakiuria
|
0.00%
0/261 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
4.1%
2/49 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/261 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
4.1%
2/49 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
4.1%
2/49 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.7%
28/261 • Number of events 28 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
8.2%
4/49 • Number of events 4 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.5%
4/261 • Number of events 4 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.5%
4/261 • Number of events 4 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Respiratory, thoracic and mediastinal disorders
Orthopnoea
|
1.5%
4/261 • Number of events 4 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhageq
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
1.5%
4/261 • Number of events 4 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
4.1%
2/49 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/261 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
4.1%
2/49 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
2.3%
6/261 • Number of events 6 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Vascular disorders
Arterial haemorrhage
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Vascular disorders
Arteriovenous fistula
|
1.5%
4/261 • Number of events 4 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Vascular disorders
Essential hypertension
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Vascular disorders
Haematoma
|
5.4%
14/261 • Number of events 14 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
4.1%
2/49 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Vascular disorders
Haemorrhage
|
1.5%
4/261 • Number of events 4 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Vascular disorders
Hypertension
|
8.4%
22/261 • Number of events 24 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
4.1%
2/49 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Vascular disorders
Hypotension
|
3.1%
8/261 • Number of events 10 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
4.1%
2/49 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Vascular disorders
Labile blood pressure
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Vascular disorders
Peripheral venous disease
|
0.77%
2/261 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
0.00%
0/49 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
|
Vascular disorders
Accelerated hypertension
|
0.00%
0/261 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
4.1%
2/49 • Number of events 2 • Up to 12 months
The safety set consisted of all enrolled participants who had undergone insertion of the SMARTTOUCH Surround Flow (STSF) or ST catheter and use of the VISITAG SURPOINT module with external processing unit (EPU).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
- Publication restrictions are in place
Restriction type: OTHER