Trial Outcomes & Findings for Catheter Evaluation for Endocardial Ablation in Patients With Ventricular Tachycardia (NCT NCT00412607)
NCT ID: NCT00412607
Last Updated: 2025-02-04
Results Overview
The long-term primary safety endpoint is the percentage of subjects that expire from all-cause mortality within 12-months post ablation.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
249 participants
Primary outcome timeframe
12-month post ablation
Results posted on
2025-02-04
Participant Flow
The first subject was enrolled on April 3, 2007. Subject enrollment was completed on May 19, 2009 after reaching the minimum enrollment criteria of two hundred forty-nine (249) subjects. Subject follow-up was completed on June 8, 2012.
Participant milestones
| Measure |
NAVISTAR THERMOCOOL Catheter
NaviStar ThermoCool Deflectable Diagnostic/Ablation Catheter for the Treatment of Ventricular Tachycardia.
|
|---|---|
|
Overall Study
STARTED
|
249
|
|
Overall Study
Started Study Catheter
|
233
|
|
Overall Study
COMPLETED
|
145
|
|
Overall Study
NOT COMPLETED
|
104
|
Reasons for withdrawal
| Measure |
NAVISTAR THERMOCOOL Catheter
NaviStar ThermoCool Deflectable Diagnostic/Ablation Catheter for the Treatment of Ventricular Tachycardia.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
9
|
|
Overall Study
Lost to Follow-up
|
19
|
|
Overall Study
Death
|
61
|
|
Overall Study
Not meet inclusion/exclusion Criteria
|
15
|
Baseline Characteristics
Catheter Evaluation for Endocardial Ablation in Patients With Ventricular Tachycardia
Baseline characteristics by cohort
| Measure |
NAVISTAR THERMOCOOL Catheter
n=249 Participants
NaviStar ThermoCool Deflectable Diagnostic/Ablation Catheter for the Treatment of Ventricular Tachycardia.
|
|---|---|
|
Age, Continuous
|
67.4 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
234 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
14 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
229 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
4 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
249 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12-month post ablationPopulation: Safety analysis population - subjects who underwent insertion of the study catheter.
The long-term primary safety endpoint is the percentage of subjects that expire from all-cause mortality within 12-months post ablation.
Outcome measures
| Measure |
NAVISTAR THERMOCOOL Catheter
n=233 Participants
NaviStar ThermoCool Deflectable Diagnostic/Ablation Catheter for the Treatment of Ventricular Tachycardia.
|
Reported Recurrence
Subjects reported recurrence of Ventricular Tachycardia (VT) at 12-month, 3-year follow-up visit
|
Reported No Recurrence
Subjects reported no recurrence of Ventricular Tachycardia (VT) at 12-month, 3-year follow-up visit
|
|---|---|---|---|
|
The Percentage of Subjects That Expire From All-cause Mortality Within 12-months Post Ablation.
|
13.3 percentage of mortality
Interval 0.0 to 17.5
|
—
|
—
|
PRIMARY outcome
Timeframe: Seven days post ablation procedurePopulation: Safety Analysis Cohort - defined as subjects who underwent insertion of the study catheter.
The acute primary safety endpoint is the percentage of subjects who experienced cardiovascular-specific adverse events (CSAE) within seven days of the ablation procedure.
Outcome measures
| Measure |
NAVISTAR THERMOCOOL Catheter
n=233 Participants
NaviStar ThermoCool Deflectable Diagnostic/Ablation Catheter for the Treatment of Ventricular Tachycardia.
|
Reported Recurrence
Subjects reported recurrence of Ventricular Tachycardia (VT) at 12-month, 3-year follow-up visit
|
Reported No Recurrence
Subjects reported no recurrence of Ventricular Tachycardia (VT) at 12-month, 3-year follow-up visit
|
|---|---|---|---|
|
The Percentage of Subjects Who Experienced Cardiovascular-specific Adverse Events (CSAE) Within Seven Days of the Ablation Procedure.
|
4.3 percentage of Adverse Event
Interval 0.0 to 7.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Duration from post-procedure to hospital discharge, up to 2 daysPopulation: Subjects in the efficacy analysis cohort who had targeted ventricular tachycardia ablated were included. Efficacy Analysis Cohort includes subjects who are enrolled and treated with the study catheter in compliance with the protocol and treated specifically for the study-related arrhythmia.
Acute success was defined as the subjects receiving successful ablation of all targeted Ventricular Tachycardia (VT) and no recurrence prior to hospital discharge.
Outcome measures
| Measure |
NAVISTAR THERMOCOOL Catheter
n=215 Participants
NaviStar ThermoCool Deflectable Diagnostic/Ablation Catheter for the Treatment of Ventricular Tachycardia.
|
Reported Recurrence
Subjects reported recurrence of Ventricular Tachycardia (VT) at 12-month, 3-year follow-up visit
|
Reported No Recurrence
Subjects reported no recurrence of Ventricular Tachycardia (VT) at 12-month, 3-year follow-up visit
|
|---|---|---|---|
|
Percentage of Subjects Achieved Acute Success
|
74.9 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 6-month follow upPopulation: Subjects in the Efficacy analysis cohort who had available chronic effectiveness outcomes were included
Chronic effectiveness is defined as subjects without recurrence of sustained monomorphic ventricular tachycardia (SMVT) at 6 month follow-up. For subjects with Implantable Cardioverter Defibrillator (ICD), recurrences of SMVT were defined as appropriate ICD shock therapies. For subjects without ICDs, recurrences of SMVT were recorded in the follow-up visits form. Besides SMVT, recurrence of incessant VT was also captured in this study. Recurrence of incessant VT was recorded up to 6 month post ablation procedure but not beyond.
Outcome measures
| Measure |
NAVISTAR THERMOCOOL Catheter
n=184 Participants
NaviStar ThermoCool Deflectable Diagnostic/Ablation Catheter for the Treatment of Ventricular Tachycardia.
|
Reported Recurrence
Subjects reported recurrence of Ventricular Tachycardia (VT) at 12-month, 3-year follow-up visit
|
Reported No Recurrence
Subjects reported no recurrence of Ventricular Tachycardia (VT) at 12-month, 3-year follow-up visit
|
|---|---|---|---|
|
Percentage of Subjects Who Achieved Chronic Effectiveness
|
62.0 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 3-year follow upPopulation: Subjects in the efficacy analysis cohort who completed 12-month, 2-year, or 3-year follow-up and had available long-term efficacy outcomes at the corresponding time points were included.
Long-term success is defined as patient-reported non-recurrence of Ventricular Tachycardia (VT) at the12-month, second year, and third year phone follow-ups.
Outcome measures
| Measure |
NAVISTAR THERMOCOOL Catheter
n=176 Participants
NaviStar ThermoCool Deflectable Diagnostic/Ablation Catheter for the Treatment of Ventricular Tachycardia.
|
Reported Recurrence
n=176 Participants
Subjects reported recurrence of Ventricular Tachycardia (VT) at 12-month, 3-year follow-up visit
|
Reported No Recurrence
n=176 Participants
Subjects reported no recurrence of Ventricular Tachycardia (VT) at 12-month, 3-year follow-up visit
|
|---|---|---|---|
|
Number of Subjects Achieved Long-term Efficacy Success
12-Month Follow-up
|
176 participants
|
40 participants
|
136 participants
|
|
Number of Subjects Achieved Long-term Efficacy Success
2-Year Follow-up
|
161 participants
|
48 participants
|
113 participants
|
|
Number of Subjects Achieved Long-term Efficacy Success
3-Year Follow-up
|
141 participants
|
34 participants
|
107 participants
|
SECONDARY outcome
Timeframe: 6-month follow upPopulation: Efficacy analysis cohort subjects with LVEF data available. The statistics for Baseline and 6-month were based on data available from 219 and 166 subjects respectively; the mean change was based on 163 subjects with data at both Baseline and 6-month. Hence the mean change is not the simple subtraction between Baseline and 6-month.
Change in Left Ventricular Ejection Fraction (LVEF) from baseline to 6 month follow up. LVEF is a measure of the percentage of blood leaving heart each time it contracts. Baseline LVEF data were collected at pre ablation procedure, at hospital discharge, and at the 6-month follow-up visit.
Outcome measures
| Measure |
NAVISTAR THERMOCOOL Catheter
n=219 Participants
NaviStar ThermoCool Deflectable Diagnostic/Ablation Catheter for the Treatment of Ventricular Tachycardia.
|
Reported Recurrence
Subjects reported recurrence of Ventricular Tachycardia (VT) at 12-month, 3-year follow-up visit
|
Reported No Recurrence
Subjects reported no recurrence of Ventricular Tachycardia (VT) at 12-month, 3-year follow-up visit
|
|---|---|---|---|
|
Change in Left Ventricular Ejection Fraction at 6 Month From Baseline
Baseline (Pre-Ablation)
|
30.6 percentage of blood leaving the heart
Standard Deviation 12.5
|
—
|
—
|
|
Change in Left Ventricular Ejection Fraction at 6 Month From Baseline
6-Month
|
32.9 percentage of blood leaving the heart
Standard Deviation 11.53
|
—
|
—
|
|
Change in Left Ventricular Ejection Fraction at 6 Month From Baseline
Change from Baseline
|
0.9 percentage of blood leaving the heart
Standard Deviation 8.23
|
—
|
—
|
Adverse Events
NAVISTAR THERMOCOOL Catheter
Serious events: 37 serious events
Other events: 177 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
NAVISTAR THERMOCOOL Catheter
n=233 participants at risk
NaviStar ThermoCool Deflectable Diagnostic/Ablation Catheter for the Treatment of Ventricular Tachycardia.
|
|---|---|
|
Cardiac disorders
Bradycardia
|
0.43%
1/233 • Number of events 1 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Cardiac disorders
Death
|
1.3%
3/233 • Number of events 3 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Cardiac disorders
Congestive Heart Failure
|
2.1%
5/233 • Number of events 5 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Cardiac disorders
Palpitations
|
0.43%
1/233 • Number of events 1 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Cardiac disorders
Pericardial Effusion
|
1.3%
3/233 • Number of events 3 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Cardiac disorders
Coronary Artery Disease Intervention
|
0.43%
1/233 • Number of events 1 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Cardiac disorders
Ventricular Tachycardia
|
3.4%
8/233 • Number of events 8 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Cardiac disorders
Pulseless Electrical Activity at Device Site
|
0.43%
1/233 • Number of events 1 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Infections and infestations
Staphylococcus
|
0.43%
1/233 • Number of events 1 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Infections and infestations
Fever
|
0.43%
1/233 • Number of events 1 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Infections and infestations
MRSA
|
0.86%
2/233 • Number of events 2 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Infections and infestations
Pneumonia
|
0.43%
1/233 • Number of events 1 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Infections and infestations
Sepsis
|
0.43%
1/233 • Number of events 1 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Infections and infestations
Urinary Tract Infection/Urinary Retention Retention
|
2.1%
5/233 • Number of events 6 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Injury, poisoning and procedural complications
Fluid Overload
|
0.43%
1/233 • Number of events 1 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Injury, poisoning and procedural complications
AV Fistula
|
0.43%
1/233 • Number of events 1 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Injury, poisoning and procedural complications
Aortoiliac Dissection
|
0.43%
1/233 • Number of events 1 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Injury, poisoning and procedural complications
Thrombus
|
0.43%
1/233 • Number of events 1 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Injury, poisoning and procedural complications
Hematoma
|
0.43%
1/233 • Number of events 1 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Injury, poisoning and procedural complications
Hemodynamically Unstable
|
0.43%
1/233 • Number of events 1 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Injury, poisoning and procedural complications
Pseudoaneurysm
|
0.86%
2/233 • Number of events 2 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Injury, poisoning and procedural complications
Tamponade
|
0.43%
1/233 • Number of events 1 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
0.43%
1/233 • Number of events 1 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Respiratory, thoracic and mediastinal disorders
Renal Failure
|
1.3%
3/233 • Number of events 3 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Respiratory, thoracic and mediastinal disorders
Adult Respiratory Failure
|
0.43%
1/233 • Number of events 1 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
Other adverse events
| Measure |
NAVISTAR THERMOCOOL Catheter
n=233 participants at risk
NaviStar ThermoCool Deflectable Diagnostic/Ablation Catheter for the Treatment of Ventricular Tachycardia.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.43%
1/233 • Number of events 1 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Cardiac disorders
Atrioventricular node ablation
|
0.43%
1/233 • Number of events 1 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Cardiac disorders
Angina pectoris
|
2.6%
6/233 • Number of events 6 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Cardiac disorders
Arrhythmia - Not Elsewhere Classified
|
2.6%
6/233 • Number of events 7 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Cardiac disorders
Atrial Tachycardia
|
2.1%
5/233 • Number of events 5 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Cardiac disorders
Atrial fibrillation
|
9.4%
22/233 • Number of events 30 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Cardiac disorders
Biventricular assist device placed
|
0.43%
1/233 • Number of events 1 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Cardiac disorders
Bradycardia
|
0.43%
1/233 • Number of events 1 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Cardiac disorders
Cardiac - Not Elsewhere Classified
|
2.6%
6/233 • Number of events 6 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Cardiac disorders
Cardiac Arrest
|
1.3%
3/233 • Number of events 3 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Cardiac disorders
Cardiac stents
|
1.7%
4/233 • Number of events 4 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Cardiac disorders
Chest Pain - Not Elsewhere Classified
|
1.3%
3/233 • Number of events 3 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Cardiac disorders
Congestive Heart Failure
|
21.5%
50/233 • Number of events 78 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Cardiac disorders
Coronary Artery Disease
|
2.6%
6/233 • Number of events 6 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Cardiac disorders
Endocarditis
|
0.43%
1/233 • Number of events 1 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Cardiac disorders
Heart Block
|
1.3%
3/233 • Number of events 3 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Cardiac disorders
Heart Transplant
|
0.86%
2/233 • Number of events 2 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Cardiac disorders
Implantable Cardioverter Defibrillator maintenance
|
4.3%
10/233 • Number of events 10 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Cardiac disorders
Implantable Cardioverter Defibrillator shock - Not Elsewhere Classified
|
4.3%
10/233 • Number of events 12 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Cardiac disorders
Mitral valve regurgitation
|
0.86%
2/233 • Number of events 3 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Cardiac disorders
Myocardial Infarction
|
2.1%
5/233 • Number of events 5 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Cardiac disorders
Pericardial effusion
|
0.86%
2/233 • Number of events 2 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Cardiac disorders
Pleural Effusion
|
0.86%
2/233 • Number of events 2 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Cardiac disorders
Thrombus
|
1.7%
4/233 • Number of events 4 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Cardiac disorders
Ventricular Tachycardia
|
29.2%
68/233 • Number of events 125 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Gastrointestinal disorders
Abdominal pain - Not Elsewhere Classified
|
0.43%
1/233 • Number of events 1 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Gastrointestinal disorders
Appendicitis
|
0.43%
1/233 • Number of events 1 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Gastrointestinal disorders
Ascites
|
0.43%
1/233 • Number of events 1 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Gastrointestinal disorders
Colitis
|
0.43%
1/233 • Number of events 1 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Gastrointestinal disorders
Esophageal cancer
|
0.43%
1/233 • Number of events 1 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Gastrointestinal disorders
Gastrointestinal bleed
|
1.3%
3/233 • Number of events 3 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Gastrointestinal disorders
Ulcer
|
0.43%
1/233 • Number of events 1 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
General disorders
Chest Pain - Not Elsewhere Classified
|
0.43%
1/233 • Number of events 1 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
General disorders
Chest Pain - Non cardiac
|
2.6%
6/233 • Number of events 6 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
General disorders
Diabetes
|
0.43%
1/233 • Number of events 1 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
General disorders
Elective - Dental
|
0.43%
1/233 • Number of events 1 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
General disorders
Fluid overload
|
1.3%
3/233 • Number of events 3 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
General disorders
Pain - Not Elsewhere Classified
|
0.43%
1/233 • Number of events 1 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
General disorders
Weakness
|
1.3%
3/233 • Number of events 3 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Infections and infestations
Bacteremia
|
0.43%
1/233 • Number of events 1 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Infections and infestations
Bronchitis
|
0.86%
2/233 • Number of events 2 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Infections and infestations
Fever
|
0.86%
2/233 • Number of events 2 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Infections and infestations
Gangrene
|
0.43%
1/233 • Number of events 1 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Infections and infestations
Infection - Not Elsewhere Classified
|
0.86%
2/233 • Number of events 2 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Infections and infestations
Knee infection
|
0.43%
1/233 • Number of events 2 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Infections and infestations
Methicillin-resistant Staphylococcus aureus
|
0.43%
1/233 • Number of events 1 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Infections and infestations
Pneumonia
|
3.4%
8/233 • Number of events 9 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Infections and infestations
Prostatitis
|
0.43%
1/233 • Number of events 1 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Infections and infestations
Sepsis
|
3.0%
7/233 • Number of events 7 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Infections and infestations
Urinary Tract Infections
|
0.43%
1/233 • Number of events 1 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Infections and infestations
Viral infection
|
0.86%
2/233 • Number of events 2 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula
|
0.43%
1/233 • Number of events 1 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Injury, poisoning and procedural complications
Cardiac - Not Elsewhere Classified
|
0.86%
2/233 • Number of events 2 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Injury, poisoning and procedural complications
Fracture - Fibula
|
0.43%
1/233 • Number of events 2 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Injury, poisoning and procedural complications
Fracture - hip
|
0.43%
1/233 • Number of events 1 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Injury, poisoning and procedural complications
Fracture - jaw
|
0.43%
1/233 • Number of events 1 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Injury, poisoning and procedural complications
Fracture - pelvis
|
0.43%
1/233 • Number of events 1 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Injury, poisoning and procedural complications
Fracture - rib
|
0.43%
1/233 • Number of events 1 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Injury, poisoning and procedural complications
Fracture - wrist
|
0.43%
1/233 • Number of events 1 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Injury, poisoning and procedural complications
Hematoma
|
3.9%
9/233 • Number of events 9 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Injury, poisoning and procedural complications
Pseudoaneurysm
|
0.86%
2/233 • Number of events 2 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Injury, poisoning and procedural complications
Spider bite
|
0.43%
1/233 • Number of events 1 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Injury, poisoning and procedural complications
Wound - Not Elsewhere Classified
|
0.43%
1/233 • Number of events 1 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Investigations
Death
|
5.2%
12/233 • Number of events 12 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
2.6%
6/233 • Number of events 6 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.43%
1/233 • Number of events 1 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowel Cancer
|
0.43%
1/233 • Number of events 1 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer
|
0.43%
1/233 • Number of events 1 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer
|
0.86%
2/233 • Number of events 2 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cysts
|
0.43%
1/233 • Number of events 1 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic Cancer
|
0.43%
1/233 • Number of events 1 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Nervous system disorders
Ataxia
|
0.43%
1/233 • Number of events 1 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.43%
1/233 • Number of events 1 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Nervous system disorders
Neuropathy
|
0.43%
1/233 • Number of events 1 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Nervous system disorders
Stroke
|
0.86%
2/233 • Number of events 2 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Nervous system disorders
Syncope
|
0.43%
1/233 • Number of events 2 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Nervous system disorders
Vertigo
|
0.43%
1/233 • Number of events 1 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Nervous system disorders
Visual disturbance
|
0.43%
1/233 • Number of events 1 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Psychiatric disorders
Schizophrenia
|
0.43%
1/233 • Number of events 1 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Renal and urinary disorders
Renal - Not Elsewhere Classified
|
0.43%
1/233 • Number of events 1 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Renal and urinary disorders
Renal Failure
|
2.1%
5/233 • Number of events 5 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Renal and urinary disorders
Hematuria
|
0.43%
1/233 • Number of events 1 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Renal and urinary disorders
Kidney stone
|
0.43%
1/233 • Number of events 1 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.43%
1/233 • Number of events 1 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
2.1%
5/233 • Number of events 5 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Respiratory, thoracic and mediastinal disorders
Diaphragmatic paralysis
|
0.43%
1/233 • Number of events 1 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.43%
1/233 • Number of events 1 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Respiratory, thoracic and mediastinal disorders
Edema
|
0.43%
1/233 • Number of events 1 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Respiratory, thoracic and mediastinal disorders
Epitaxis
|
0.86%
2/233 • Number of events 2 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Respiratory, thoracic and mediastinal disorders
Fibrosis
|
0.43%
1/233 • Number of events 1 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Vascular disorders
Aortic Aneurysm
|
1.3%
3/233 • Number of events 3 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Vascular disorders
Hypertension
|
0.86%
2/233 • Number of events 2 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Vascular disorders
Hypotension
|
2.1%
5/233 • Number of events 5 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Vascular disorders
Revascularization
|
0.43%
1/233 • Number of events 2 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Investigations
Transplant - Not Elsewhere Classified
|
0.43%
1/233 • Number of events 1 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nodule
|
0.43%
1/233 • Number of events 1 • 3-year follow up
Serious adverse events (SAE) were those that meet the protocol definition of SAE, excluding the Cardiovascular Specific Adverse Events occurring within 7 days of the ablation procedure, but including deaths that occurred within the time frame. Deaths occurring after 7 days post-ablation were considered non-serious per the protocol definition.
|
Additional Information
Karen Cropper, Manager, Clinical Operations
Biosense Webster, Inc.
Phone: (800) 729-9010
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Please contact Biosense Webster for additional information.
- Publication restrictions are in place
Restriction type: OTHER