Trial Outcomes & Findings for CONVERGE - Epi/Endo Ablation For Treatment of Persistent Atrial Fibrillation(AF) (NCT NCT01984346)
NCT ID: NCT01984346
Last Updated: 2023-11-13
Results Overview
This binary primary endpoint measures number of patients to achieve freedom from AF/AT/AFL absent class I and III AADs except for previously failed or intolerant I or III AAD with no increase in dosage following the 3-month blanking period through the 12 months post procedure follow-up visit will be compared between the two treatment groups using a chi-square test using a two-sided alpha of .05 to determine if superiority of the treatment arm is attained.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
170 participants
Primary outcome timeframe
12 Months
Results posted on
2023-11-13
Participant Flow
Recruiting for the CONVERGE Study began with first site IRB approval Nov 13, 2013. Recruiting locations included physician offices, clinics and site clinical study offices. * The first milestone for recruiting purposes was the first 25 patients treated. This milestone was reached July 06, 2015. * Milestone two was hit with the attainment of 50 patients treated on September 28, 2016 * The third milestone was the approval of the total cohort of 153 patients by the FDA on November 17, 2017.
10 subjects were consented but withdrew prior to assignment to a treatment arm. 5 subjects were excluded by Investigator decision, 3 subjects withdrew consent for unkown reasons and 2 subjects withdrew based on insurance coverage considerations
Participant milestones
| Measure |
Convergent Procedure
Procedure/Surgery: Convergent Procedure using EPi-Sense-AF Guided Coagulation System with Endocardial Catheter Ablation Treatment
AtriCure EPi-Sense-AF Guided Coagulation System with VisiTrax: Convergent Epicardial Endocardial Ablation Procedure
Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering: Endocardial Catheter Ablation Procedure
|
Standalone Endocardial Catheter Ablation
Procedure/Surgery: Endocardial Catheter Ablation Treatment
Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering: Endocardial Catheter Ablation Procedure
|
|---|---|---|
|
Overall Study
STARTED
|
115
|
55
|
|
Overall Study
Treated
|
102
|
51
|
|
Overall Study
COMPLETED
|
98
|
50
|
|
Overall Study
NOT COMPLETED
|
17
|
5
|
Reasons for withdrawal
| Measure |
Convergent Procedure
Procedure/Surgery: Convergent Procedure using EPi-Sense-AF Guided Coagulation System with Endocardial Catheter Ablation Treatment
AtriCure EPi-Sense-AF Guided Coagulation System with VisiTrax: Convergent Epicardial Endocardial Ablation Procedure
Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering: Endocardial Catheter Ablation Procedure
|
Standalone Endocardial Catheter Ablation
Procedure/Surgery: Endocardial Catheter Ablation Treatment
Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering: Endocardial Catheter Ablation Procedure
|
|---|---|---|
|
Overall Study
Physician Decision
|
4
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
|
Overall Study
Enrollment Closed
|
8
|
1
|
|
Overall Study
Insurance Coverage
|
1
|
0
|
|
Overall Study
Intra-operative Exclusion
|
2
|
0
|
Baseline Characteristics
CONVERGE - Epi/Endo Ablation For Treatment of Persistent Atrial Fibrillation(AF)
Baseline characteristics by cohort
| Measure |
Convergent Procedure
n=102 Participants
Procedure/Surgery: Convergent Procedure using EPi-Sense-AF Guided Coagulation System with Endocardial Catheter Ablation Treatment
AtriCure EPi-Sense-AF Guided Coagulation System with VisiTrax: Convergent Epicardial Endocardial Ablation Procedure
Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering: Endocardial Catheter Ablation Procedure
|
Standalone Endocardial Catheter Ablation
n=51 Participants
Procedure/Surgery: Endocardial Catheter Ablation Treatment
Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering: Endocardial Catheter Ablation Procedure
|
Total
n=153 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
46 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
56 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
80 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
100 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
150 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
96 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
146 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Height
|
177.7 cm
STANDARD_DEVIATION 8.43 • n=5 Participants
|
173.9 cm
STANDARD_DEVIATION 11.64 • n=7 Participants
|
176.5 cm
STANDARD_DEVIATION 9.76 • n=5 Participants
|
|
Weight
|
104.3 Kilograms
STANDARD_DEVIATION 19.985 • n=5 Participants
|
106.25 Kilograms
STANDARD_DEVIATION 23.903 • n=7 Participants
|
105.0 Kilograms
STANDARD_DEVIATION 21.31 • n=5 Participants
|
|
BMI
|
32.99 Kg/M2
STANDARD_DEVIATION 5.861 • n=5 Participants
|
35.11 Kg/M2
STANDARD_DEVIATION 7.128 • n=7 Participants
|
33.70 Kg/M2
STANDARD_DEVIATION 6.37 • n=5 Participants
|
|
Smoking History
Never Smoked
|
45 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Smoking History
Past Smoker
|
48 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Smoking History
Current Smoker
|
9 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Smoking History
Unknown
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Persistent AF
Persistent AF
|
64 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
|
Persistent AF
Long-Standing Persistent AF
|
38 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 MonthsThis binary primary endpoint measures number of patients to achieve freedom from AF/AT/AFL absent class I and III AADs except for previously failed or intolerant I or III AAD with no increase in dosage following the 3-month blanking period through the 12 months post procedure follow-up visit will be compared between the two treatment groups using a chi-square test using a two-sided alpha of .05 to determine if superiority of the treatment arm is attained.
Outcome measures
| Measure |
Convergent Procedure
n=102 Participants
Procedure/Surgery: Convergent Procedure using EPi-Sense-AF Guided Coagulation System with Endocardial Catheter Ablation Treatment
AtriCure EPi-Sense-AF Guided Coagulation System with VisiTrax: Convergent Epicardial Endocardial Ablation Procedure
Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering: Endocardial Catheter Ablation Procedure
|
Standalone Endocardial Catheter Ablation
n=51 Participants
Procedure/Surgery: Endocardial Catheter Ablation Treatment
Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering: Endocardial Catheter Ablation Procedure
|
|---|---|---|
|
Primary Efficacy Endpoint - Number of Participants to Achieve Freedom From AF/AT/AFL.
|
67 Participants
|
25 Participants
|
PRIMARY outcome
Timeframe: 30 daysThe primary safety analysis will measure the number of Major Adverse Events (MAE) collected from the start of the coagulation procedure to 30 days post procedure.
Outcome measures
| Measure |
Convergent Procedure
n=102 Participants
Procedure/Surgery: Convergent Procedure using EPi-Sense-AF Guided Coagulation System with Endocardial Catheter Ablation Treatment
AtriCure EPi-Sense-AF Guided Coagulation System with VisiTrax: Convergent Epicardial Endocardial Ablation Procedure
Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering: Endocardial Catheter Ablation Procedure
|
Standalone Endocardial Catheter Ablation
n=51 Participants
Procedure/Surgery: Endocardial Catheter Ablation Treatment
Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering: Endocardial Catheter Ablation Procedure
|
|---|---|---|
|
Primary Safety Analysis
|
8 Number of events
|
0 Number of events
|
SECONDARY outcome
Timeframe: 12 monthPopulation: Summary of Serious Adverse Events within 12 months occurring in \>3% of the subjects in any treatment group (Safety Population)
The secondary safety endpoint for the study was the number of participants with serious adverse events (SAEs) in the study through the 12-months post-procedure.
Outcome measures
| Measure |
Convergent Procedure
n=102 Participants
Procedure/Surgery: Convergent Procedure using EPi-Sense-AF Guided Coagulation System with Endocardial Catheter Ablation Treatment
AtriCure EPi-Sense-AF Guided Coagulation System with VisiTrax: Convergent Epicardial Endocardial Ablation Procedure
Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering: Endocardial Catheter Ablation Procedure
|
Standalone Endocardial Catheter Ablation
n=51 Participants
Procedure/Surgery: Endocardial Catheter Ablation Treatment
Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering: Endocardial Catheter Ablation Procedure
|
|---|---|---|
|
Secondary Safety Endpoint - Serious Adverse Events Through 12 Months Post-procedure.
Respiratory, Thoracic & Mediastinal Disorder- Pulmonary Edema
|
3 Participants
|
0 Participants
|
|
Secondary Safety Endpoint - Serious Adverse Events Through 12 Months Post-procedure.
General Disorder and Administration Site-Chest Pain
|
3 Participants
|
0 Participants
|
|
Secondary Safety Endpoint - Serious Adverse Events Through 12 Months Post-procedure.
Cardiac Disorders-Cardiac Tamponade
|
4 Participants
|
0 Participants
|
|
Secondary Safety Endpoint - Serious Adverse Events Through 12 Months Post-procedure.
Cardiac Disorders- Pericardial Effusion
|
4 Participants
|
0 Participants
|
|
Secondary Safety Endpoint - Serious Adverse Events Through 12 Months Post-procedure.
Cardiac Disorders- Pericarditis
|
3 Participants
|
0 Participants
|
|
Secondary Safety Endpoint - Serious Adverse Events Through 12 Months Post-procedure.
Cardiac Disorders- Sinus Node Dysfunction
|
0 Participants
|
2 Participants
|
|
Secondary Safety Endpoint - Serious Adverse Events Through 12 Months Post-procedure.
Cardiac Disorders-Cardiac Failure Congestive
|
5 Participants
|
1 Participants
|
|
Secondary Safety Endpoint - Serious Adverse Events Through 12 Months Post-procedure.
Infections and Infestations- Pneumonia
|
3 Participants
|
4 Participants
|
|
Secondary Safety Endpoint - Serious Adverse Events Through 12 Months Post-procedure.
Not applicable
|
77 Participants
|
44 Participants
|
SECONDARY outcome
Timeframe: 12 MonthsPopulation: The number of subjects in the EPi- Sense group that achieved at least 90% reduction at 12 months, compared to subjects in the Catheter Ablation group.
AF Burden Reduction of at Least 90% at 12-Months (ITT Population): The first secondary effectiveness endpoint in the fixed-sequence testing was defined as at least 90% reduction in AF burden, absent of an increased dose or new class I/III AADs, at 12 months compared to baseline.
Outcome measures
| Measure |
Convergent Procedure
n=102 Participants
Procedure/Surgery: Convergent Procedure using EPi-Sense-AF Guided Coagulation System with Endocardial Catheter Ablation Treatment
AtriCure EPi-Sense-AF Guided Coagulation System with VisiTrax: Convergent Epicardial Endocardial Ablation Procedure
Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering: Endocardial Catheter Ablation Procedure
|
Standalone Endocardial Catheter Ablation
n=51 Participants
Procedure/Surgery: Endocardial Catheter Ablation Treatment
Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering: Endocardial Catheter Ablation Procedure
|
|---|---|---|
|
Number of Patients With AF Burden Reduction of at Least 90% at 12 Months Compared to Baseline
|
60 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: 12 MonthsNumber of patients with AF Freedom through 12 Months (ITT Population) absent of an increased dose or new class I/III AAD's
Outcome measures
| Measure |
Convergent Procedure
n=102 Participants
Procedure/Surgery: Convergent Procedure using EPi-Sense-AF Guided Coagulation System with Endocardial Catheter Ablation Treatment
AtriCure EPi-Sense-AF Guided Coagulation System with VisiTrax: Convergent Epicardial Endocardial Ablation Procedure
Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering: Endocardial Catheter Ablation Procedure
|
Standalone Endocardial Catheter Ablation
n=51 Participants
Procedure/Surgery: Endocardial Catheter Ablation Treatment
Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering: Endocardial Catheter Ablation Procedure
|
|---|---|---|
|
AF Freedom Through 12 Months- Absent of an Increased Dose or New Class I/III AAD's.
|
71 percentage of participants
Interval 61.7 to 79.4
|
51 percentage of participants
Interval 37.4 to 64.7
|
SECONDARY outcome
Timeframe: 12 MonthsNumber of subjects with AF freedom through 12 months achieved in the EPi-Sense group compared to subjects in the Catheter Ablation group.
Outcome measures
| Measure |
Convergent Procedure
n=102 Participants
Procedure/Surgery: Convergent Procedure using EPi-Sense-AF Guided Coagulation System with Endocardial Catheter Ablation Treatment
AtriCure EPi-Sense-AF Guided Coagulation System with VisiTrax: Convergent Epicardial Endocardial Ablation Procedure
Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering: Endocardial Catheter Ablation Procedure
|
Standalone Endocardial Catheter Ablation
n=51 Participants
Procedure/Surgery: Endocardial Catheter Ablation Treatment
Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering: Endocardial Catheter Ablation Procedure
|
|---|---|---|
|
Number of Subjects With AF Burden Reduction of at Least 90% at 12 Months Relative to Baseline, Regardless of Class I/III AADs.
|
95 percentage of participants
Interval 88.8 to 99.2
|
88.6 percentage of participants
Interval 75.4 to 96.2
|
SECONDARY outcome
Timeframe: 12 monthsChange was calculated as the value at 12 months minus the value at baseline. The University of Toronto's Atrial Fibrillation Severity Scale (AFSS) is a composite score of overall subject-perceived severity, global well-being, atrial fibrillation frequency, and atrial fibrillation duration. The score ranges from 3 to 30, with higher scores indicating greater atrial fibrillation burden.
Outcome measures
| Measure |
Convergent Procedure
n=102 Participants
Procedure/Surgery: Convergent Procedure using EPi-Sense-AF Guided Coagulation System with Endocardial Catheter Ablation Treatment
AtriCure EPi-Sense-AF Guided Coagulation System with VisiTrax: Convergent Epicardial Endocardial Ablation Procedure
Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering: Endocardial Catheter Ablation Procedure
|
Standalone Endocardial Catheter Ablation
n=51 Participants
Procedure/Surgery: Endocardial Catheter Ablation Treatment
Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering: Endocardial Catheter Ablation Procedure
|
|---|---|---|
|
Change in Atrial Fibrillation Severity Scale (AFSS)
|
-11.7 score on a scale
Standard Deviation 7.71
|
-10.3 score on a scale
Standard Deviation 7.16
|
SECONDARY outcome
Timeframe: 12 MonthsPopulation: Subjects evaluated for quality of life using SF- 36 survey.
Change was calculated as the value at 12 months minus the value at baseline. The 36-Item Short Form Health Survey (SF-36) is used to determine a physical composite score based on following subscales: limitations in physical activities because of health problems; limitations in usual role activities because of physical health problems; bodily pain; vitality (energy and fatigue); and general health perceptions. The subscale scores are transformed into a range from 0 to 100, with 0=worst HRQL, 100=best HRQL. The physical component scores are constructed as a T-score with a mean of 50 and standard deviation of 10 and no minimum or maximum score, with higher scores indicating better health status.
Outcome measures
| Measure |
Convergent Procedure
n=102 Participants
Procedure/Surgery: Convergent Procedure using EPi-Sense-AF Guided Coagulation System with Endocardial Catheter Ablation Treatment
AtriCure EPi-Sense-AF Guided Coagulation System with VisiTrax: Convergent Epicardial Endocardial Ablation Procedure
Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering: Endocardial Catheter Ablation Procedure
|
Standalone Endocardial Catheter Ablation
n=51 Participants
Procedure/Surgery: Endocardial Catheter Ablation Treatment
Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering: Endocardial Catheter Ablation Procedure
|
|---|---|---|
|
Change in Quality of Life Physical Health Composite Scores Using Short Form Health Survey (SF-36)
|
7.3 score on a scale
Standard Deviation 10.67
|
5.7 score on a scale
Standard Deviation 10.49
|
SECONDARY outcome
Timeframe: 12 monthsChange was calculated as the value at 12 months minus the value at baseline. The 36-Item Short Form Health Survey (SF-36) is used to determine a mental composite score based on the following subscales: general mental health (psychological distress and well-being); limitations in usual role activities because of emotional problems; and general health perceptions. The subscale scores are transformed into a range from 0 to 100, with 0=worst HRQL, 100=best HRQL. The physical and mental component scores are constructed as a T-score with a mean of 50 and standard deviation of 10 and no minimum or maximum score, with higher scores indicating better health status.
Outcome measures
| Measure |
Convergent Procedure
n=102 Participants
Procedure/Surgery: Convergent Procedure using EPi-Sense-AF Guided Coagulation System with Endocardial Catheter Ablation Treatment
AtriCure EPi-Sense-AF Guided Coagulation System with VisiTrax: Convergent Epicardial Endocardial Ablation Procedure
Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering: Endocardial Catheter Ablation Procedure
|
Standalone Endocardial Catheter Ablation
n=51 Participants
Procedure/Surgery: Endocardial Catheter Ablation Treatment
Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering: Endocardial Catheter Ablation Procedure
|
|---|---|---|
|
Quality of Life-Change in SF-36 Mental Health Composite Score Using Short Form Survey (SF-36)
|
5.7 score on a scale
Standard Deviation 10.51
|
7.7 score on a scale
Standard Deviation 12.78
|
SECONDARY outcome
Timeframe: 12 months6 minute walk score was measured by change from baseline compared to 12-months post-procedure between the EPi-Sense and Catheter Ablation groups.
Outcome measures
| Measure |
Convergent Procedure
n=94 Participants
Procedure/Surgery: Convergent Procedure using EPi-Sense-AF Guided Coagulation System with Endocardial Catheter Ablation Treatment
AtriCure EPi-Sense-AF Guided Coagulation System with VisiTrax: Convergent Epicardial Endocardial Ablation Procedure
Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering: Endocardial Catheter Ablation Procedure
|
Standalone Endocardial Catheter Ablation
n=48 Participants
Procedure/Surgery: Endocardial Catheter Ablation Treatment
Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering: Endocardial Catheter Ablation Procedure
|
|---|---|---|
|
Change in 6-Minute Walk Score
|
9.2 Meters
Standard Deviation 120.59
|
-12.4 Meters
Standard Deviation 190.09
|
SECONDARY outcome
Timeframe: 6 MonthsChange in Left Atrial Diameter at 6 months from baseline.
Outcome measures
| Measure |
Convergent Procedure
n=99 Participants
Procedure/Surgery: Convergent Procedure using EPi-Sense-AF Guided Coagulation System with Endocardial Catheter Ablation Treatment
AtriCure EPi-Sense-AF Guided Coagulation System with VisiTrax: Convergent Epicardial Endocardial Ablation Procedure
Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering: Endocardial Catheter Ablation Procedure
|
Standalone Endocardial Catheter Ablation
n=51 Participants
Procedure/Surgery: Endocardial Catheter Ablation Treatment
Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering: Endocardial Catheter Ablation Procedure
|
|---|---|---|
|
Change in Left Atrial Diameter
|
0.1 cm
Standard Deviation .62
|
1.9 cm
Standard Deviation 6.68
|
Adverse Events
Convergent Procedure
Serious events: 97 serious events
Other events: 9 other events
Deaths: 2 deaths
Standalone Endocardial Catheter Ablation
Serious events: 41 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Convergent Procedure
n=102 participants at risk
Procedure/Surgery: Convergent Procedure using EPi-Sense-AF Guided Coagulation System with Endocardial Catheter Ablation Treatment
AtriCure EPi-Sense-AF Guided Coagulation System with VisiTrax: Convergent Epicardial Endocardial Ablation Procedure
Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering: Endocardial Catheter Ablation Procedure
|
Standalone Endocardial Catheter Ablation
n=51 participants at risk
Procedure/Surgery: Endocardial Catheter Ablation Treatment
Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering: Endocardial Catheter Ablation Procedure
|
|---|---|---|
|
Cardiac disorders
Cardiac Failure Congestive
|
5.9%
6/102 • Number of events 6 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
3.9%
2/51 • Number of events 2 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
Cardiac disorders
Cardiac Tamponade
|
3.9%
4/102 • Number of events 4 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
2.0%
1/51 • Number of events 1 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
Cardiac disorders
Pericardial Effusion
|
3.9%
4/102 • Number of events 4 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
0.00%
0/51 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
Cardiac disorders
Pericarditis
|
2.9%
3/102 • Number of events 3 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
0.00%
0/51 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
Cardiac disorders
Sinus Node Dysfunction
|
0.00%
0/102 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
3.9%
2/51 • Number of events 2 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
Cardiac disorders
Atrioventricular Block Complete
|
0.98%
1/102 • Number of events 1 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
0.00%
0/51 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
Cardiac disorders
Bradycardia
|
0.98%
1/102 • Number of events 1 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
0.00%
0/51 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
Cardiac disorders
Coronary Artery Disease
|
2.0%
2/102 • Number of events 2 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
0.00%
0/51 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
Cardiac disorders
Mitral Valve Incompetence
|
0.00%
0/102 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
2.0%
1/51 • Number of events 1 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
Gastrointestinal disorders
Abdominal Hernia
|
0.00%
0/102 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
0.00%
0/51 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
Gastrointestinal disorders
Diverticular Perforation
|
0.98%
1/102 • Number of events 1 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
0.00%
0/51 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
Gastrointestinal disorders
Enterocutaneous Fistula
|
0.98%
1/102 • Number of events 1 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
0.00%
0/51 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrage
|
2.0%
2/102 • Number of events 2 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
2.0%
1/51 • Number of events 1 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
Gastrointestinal disorders
Gastrointestinal Ulcer Haemorrhage
|
0.98%
1/102 • Number of events 1 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
0.00%
0/51 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
Gastrointestinal disorders
Haemorrhoidal Haemorrhage
|
0.00%
0/102 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
2.0%
1/51 • Number of events 1 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
Gastrointestinal disorders
Hiatus Hernia
|
0.00%
0/102 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
2.0%
1/51 • Number of events 1 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.98%
1/102 • Number of events 1 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
0.00%
0/51 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
Gastrointestinal disorders
Nausea
|
0.98%
1/102 • Number of events 1 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
0.00%
0/51 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
Gastrointestinal disorders
Salivary Gland Mass
|
0.98%
1/102 • Number of events 1 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
0.00%
0/51 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
2.0%
2/102 • Number of events 2 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
0.00%
0/51 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
General disorders
Chest Pain
|
3.9%
4/102 • Number of events 4 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
0.00%
0/51 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
General disorders
Death
|
2.0%
2/102 • Number of events 2 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
0.00%
0/51 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
General disorders
Multi-Organ Disorder
|
0.98%
1/102 • Number of events 1 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
0.00%
0/51 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
General disorders
Oedema Peripheral
|
0.00%
0/102 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
2.0%
1/51 • Number of events 1 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.98%
1/102 • Number of events 1 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
0.00%
0/51 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
Immune system disorders
Hypersensitivity
|
0.98%
1/102 • Number of events 1 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
0.00%
0/51 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
Infections and infestations
Cellulitis
|
0.00%
0/102 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
3.9%
2/51 • Number of events 2 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
Infections and infestations
Cholecystitis Infective
|
0.98%
1/102 • Number of events 1 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
0.00%
0/51 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/102 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
2.0%
1/51 • Number of events 1 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
Infections and infestations
Erysipelas
|
0.98%
1/102 • Number of events 1 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
0.00%
0/51 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
Infections and infestations
Herpes Zoster
|
0.98%
1/102 • Number of events 1 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
0.00%
0/51 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
Infections and infestations
Infection
|
2.9%
3/102 • Number of events 3 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
2.0%
1/51 • Number of events 1 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
Infections and infestations
Lobar Pneumonia
|
0.00%
0/102 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
2.0%
1/51 • Number of events 1 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.98%
1/102 • Number of events 1 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
0.00%
0/51 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
Infections and infestations
Pneumonia
|
4.9%
5/102 • Number of events 5 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
7.8%
4/51 • Number of events 4 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
Infections and infestations
Pneumonia Bacterial
|
0.00%
0/102 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
2.0%
1/51 • Number of events 1 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
Infections and infestations
Pneumonia Staphlyococcal
|
0.00%
0/102 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
2.0%
1/51 • Number of events 1 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
Infections and infestations
Postoperative Wound Infectiion
|
0.98%
1/102 • Number of events 1 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
0.00%
0/51 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/102 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
2.0%
1/51 • Number of events 1 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/102 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
2.0%
1/51 • Number of events 1 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
0.98%
1/102 • Number of events 1 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
0.00%
0/51 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
Injury, poisoning and procedural complications
Fibula Fracture
|
0.98%
1/102 • Number of events 1 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
0.00%
0/51 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
Injury, poisoning and procedural complications
Incisional Hernia
|
0.98%
1/102 • Number of events 1 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
0.00%
0/51 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
Injury, poisoning and procedural complications
Lower Limb Fracture
|
0.00%
0/102 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
2.0%
1/51 • Number of events 1 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
Injury, poisoning and procedural complications
Nerve Injury
|
0.98%
1/102 • Number of events 1 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
0.00%
0/51 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
Injury, poisoning and procedural complications
Post Procedure Haemorrhage
|
0.98%
1/102 • Number of events 1 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
0.00%
0/51 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
Injury, poisoning and procedural complications
Traumatic Haemothorax
|
0.98%
1/102 • Number of events 1 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
0.00%
0/51 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
Injury, poisoning and procedural complications
Vascular Access Complication
|
0.00%
0/102 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
2.0%
1/51 • Number of events 1 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
Investigations
Toponian Increased
|
0.00%
0/102 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
2.0%
1/51 • Number of events 1 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
Metabolism and nutrition disorders
Fluid Overload
|
2.0%
2/102 • Number of events 2 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
0.00%
0/51 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.98%
1/102 • Number of events 1 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
0.00%
0/51 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.98%
1/102 • Number of events 1 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
0.00%
0/51 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
2.0%
2/102 • Number of events 2 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
0.00%
0/51 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
Musculoskeletal and connective tissue disorders
Cervical Spinal Stenosis
|
0.98%
1/102 • Number of events 1 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
0.00%
0/51 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.98%
1/102 • Number of events 1 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
0.00%
0/51 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
Musculoskeletal and connective tissue disorders
Vertebral Foraminal Stenosis
|
0.98%
1/102 • Number of events 1 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
0.00%
0/51 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer Recurrent
|
0.00%
0/102 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
2.0%
1/51 • Number of events 1 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
0.98%
1/102 • Number of events 1 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
0.00%
0/51 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive Ductal Breast Carcinoma
|
0.98%
1/102 • Number of events 1 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
0.00%
0/51 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Kaposi's Sarcoma
|
0.00%
0/102 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
2.0%
1/51 • Number of events 1 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mestastatic Malignant Melanoma
|
0.00%
0/102 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
2.0%
1/51 • Number of events 1 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.98%
1/102 • Number of events 1 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
0.00%
0/51 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
Nervous system disorders
Cervical Myelopathy
|
0.00%
0/102 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
2.0%
1/51 • Number of events 1 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.98%
1/102 • Number of events 1 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
0.00%
0/51 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
Nervous system disorders
viith Nerve Paralysis
|
0.98%
1/102 • Number of events 1 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
0.00%
0/51 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
Psychiatric disorders
Alcoholism
|
0.98%
1/102 • Number of events 1 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
0.00%
0/51 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
Psychiatric disorders
Depression
|
0.98%
1/102 • Number of events 1 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
0.00%
0/51 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.98%
1/102 • Number of events 1 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
2.0%
1/51 • Number of events 1 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
Renal and urinary disorders
Chronic Kidney Disease
|
0.98%
1/102 • Number of events 1 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
0.00%
0/51 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/102 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
2.0%
1/51 • Number of events 1 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
Renal and urinary disorders
Renal Failure
|
0.98%
1/102 • Number of events 1 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
0.00%
0/51 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respitory Failure
|
0.98%
1/102 • Number of events 1 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
0.00%
0/51 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.98%
1/102 • Number of events 1 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
0.00%
0/51 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.98%
1/102 • Number of events 1 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
2.0%
1/51 • Number of events 1 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Respitory Failure
|
0.98%
1/102 • Number of events 1 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
0.00%
0/51 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/102 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
2.0%
1/51 • Number of events 1 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/102 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
2.0%
1/51 • Number of events 1 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
Respiratory, thoracic and mediastinal disorders
Organising Pneumonia
|
0.00%
0/102 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
2.0%
1/51 • Number of events 1 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
Respiratory, thoracic and mediastinal disorders
Plueral Effusion
|
2.0%
2/102 • Number of events 2 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
3.9%
2/51 • Number of events 2 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
Respiratory, thoracic and mediastinal disorders
Pleuratic Pain
|
0.98%
1/102 • Number of events 1 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
0.00%
0/51 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
2.9%
3/102 • Number of events 3 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
0.00%
0/51 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
Surgical and medical procedures
Cardiac Ablation
|
0.98%
1/102 • Number of events 1 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
0.00%
0/51 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
Surgical and medical procedures
Colostomy Closure
|
0.98%
1/102 • Number of events 1 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
0.00%
0/51 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
Surgical and medical procedures
knee Arthroplasty
|
2.0%
2/102 • Number of events 2 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
0.00%
0/51 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
Surgical and medical procedures
Shoulder Arthroplasty
|
0.98%
1/102 • Number of events 1 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
0.00%
0/51 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
Vascular disorders
Haematoma
|
0.00%
0/102 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
2.0%
1/51 • Number of events 1 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
Vascular disorders
Hypertensive Emergency
|
0.00%
0/102 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
2.0%
1/51 • Number of events 1 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
Vascular disorders
Jugular Vein Thrombosis
|
0.98%
1/102 • Number of events 1 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
0.00%
0/51 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
Blood and lymphatic system disorders
Anemia
|
0.98%
1/102 • Number of events 1 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
2.0%
1/51 • Number of events 1 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.98%
1/102 • Number of events 1 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
0.00%
0/51 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
Endocrine disorders
Hyperthyroidism
|
0.98%
1/102 • Number of events 1 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
0.00%
0/51 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
Other adverse events
| Measure |
Convergent Procedure
n=102 participants at risk
Procedure/Surgery: Convergent Procedure using EPi-Sense-AF Guided Coagulation System with Endocardial Catheter Ablation Treatment
AtriCure EPi-Sense-AF Guided Coagulation System with VisiTrax: Convergent Epicardial Endocardial Ablation Procedure
Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering: Endocardial Catheter Ablation Procedure
|
Standalone Endocardial Catheter Ablation
n=51 participants at risk
Procedure/Surgery: Endocardial Catheter Ablation Treatment
Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering: Endocardial Catheter Ablation Procedure
|
|---|---|---|
|
Cardiac disorders
Tamponade
|
3.9%
4/102 • Number of events 4 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
0.00%
0/51 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
Cardiac disorders
Excessive Bleeding
|
2.0%
2/102 • Number of events 2 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
0.00%
0/51 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
Nervous system disorders
Phrenic Nerve Injury
|
0.98%
1/102 • Number of events 1 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
0.00%
0/51 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
General disorders
Stoke
|
0.98%
1/102 • Number of events 1 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
0.00%
0/51 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
|
Nervous system disorders
Transient Ischemic Attack
|
0.98%
1/102 • Number of events 1 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
0.00%
0/51 • 12-month post procedure
ADVERSE EVENT (AE) Any undesirable clinical occurrence or change from patient's baseline (or pre-device procedure) condition, whether it is considered device related or not. SERIOUS ADVERSE EVENT (SAE) Serious adverse events that are deemed device-related and/or procedure-related will be captured in the study. MAJOR ADVERSE EVENTS (MAE) 9 specific major adverse events defined by protocol (including death) that are device procedure related
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER