Trial Outcomes & Findings for TactiCath Contact Force Ablation Catheter Study for Atrial Fibrillation (NCT NCT01278953)
NCT ID: NCT01278953
Last Updated: 2019-02-21
Results Overview
Includes both acute success (successful electrical isolation of all pulmonary veins) and chronic success. Re-treatment for AF with ablation or the use of Class I or Class III antiarrhythmic drugs after a 3 month blanking period constitute a treatment failure.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
300 participants
Primary outcome timeframe
12 months
Results posted on
2019-02-21
Participant Flow
300 subjects consented and were randomized, 5 subjects did not have the study device introduced. Thus 295 subjects contributed to study endpoints.
Participant milestones
| Measure |
TactiCath
Ablation performed using the TactiCath contact force sensing catheter
Catheter ablation for the treatment of paroxysmal atrial fibrillation: A pulmonary vein isolation procedure will be performed using radiofrequency ablation.
|
Control
Ablation performed using a catheter with no contact force sensing capability
Catheter ablation for the treatment of paroxysmal atrial fibrillation: A pulmonary vein isolation procedure will be performed using radiofrequency ablation.
|
|---|---|---|
|
Overall Study
STARTED
|
155
|
145
|
|
Overall Study
COMPLETED
|
146
|
134
|
|
Overall Study
NOT COMPLETED
|
9
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
TactiCath Contact Force Ablation Catheter Study for Atrial Fibrillation
Baseline characteristics by cohort
| Measure |
TactiCath
n=155 Participants
Ablation performed using the TactiCath contact force sensing catheter
Catheter ablation for the treatment of paroxysmal atrial fibrillation: A pulmonary vein isolation procedure will be performed using radiofrequency ablation.
|
Control
n=145 Participants
Ablation performed using a catheter with no contact force sensing capability
Catheter ablation for the treatment of paroxysmal atrial fibrillation: A pulmonary vein isolation procedure will be performed using radiofrequency ablation.
|
Total
n=300 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.6 years
STANDARD_DEVIATION 9.32 • n=5 Participants
|
61 years
STANDARD_DEVIATION 10.84 • n=7 Participants
|
60.3 years
STANDARD_DEVIATION 10.09 • n=5 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
100 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
191 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
148 Participants
n=5 Participants
|
141 Participants
n=7 Participants
|
289 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
96 participants
n=5 Participants
|
87 participants
n=7 Participants
|
183 participants
n=5 Participants
|
|
Region of Enrollment
Europe
|
59 participants
n=5 Participants
|
58 participants
n=7 Participants
|
117 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Primary effectiveness was calculated using the Per Protocol (PP) population (n=280). 10 subjects who had PVI attempted were excluded from the PP population.due to insufficient data. A medical panel (DSMB) blinded to treatment, adjudicated the exclusion of subjects from the analysis (n=3 from TactiCath; n=7 from Control)
Includes both acute success (successful electrical isolation of all pulmonary veins) and chronic success. Re-treatment for AF with ablation or the use of Class I or Class III antiarrhythmic drugs after a 3 month blanking period constitute a treatment failure.
Outcome measures
| Measure |
TactiCath
n=146 Participants
Ablation performed using the TactiCath contact force sensing catheter
Catheter ablation for the treatment of paroxysmal atrial fibrillation: A pulmonary vein isolation procedure will be performed using radiofrequency ablation.
|
Control
n=134 Participants
Ablation performed using a catheter with no contact force sensing capability
Catheter ablation for the treatment of paroxysmal atrial fibrillation: A pulmonary vein isolation procedure will be performed using radiofrequency ablation.
|
|---|---|---|
|
Freedom From Recurrence of Symptomatic Atrial Fibrillation, Atrial Tachycardia or Atrial Flutter
|
99 participants
|
93 participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: The Safety analysis population excludes 5 subjects who signed consent and were randomized but were not exposed to the study procedure or the study device resulting in n=295 subjects. (n=3 excluded from TactiCath; n=2 excluded from the Control group)
Includes serious adverse events occurring within 7 days of the index procedure or hospital discharge, whichever is later, and diagnosed at any time during the follow-up period.
Outcome measures
| Measure |
TactiCath
n=152 Participants
Ablation performed using the TactiCath contact force sensing catheter
Catheter ablation for the treatment of paroxysmal atrial fibrillation: A pulmonary vein isolation procedure will be performed using radiofrequency ablation.
|
Control
n=143 Participants
Ablation performed using a catheter with no contact force sensing capability
Catheter ablation for the treatment of paroxysmal atrial fibrillation: A pulmonary vein isolation procedure will be performed using radiofrequency ablation.
|
|---|---|---|
|
Incidence of Device-related Early-onset Primary Serious Adverse Events
|
3 participants
|
2 participants
|
Adverse Events
TactiCath
Serious events: 10 serious events
Other events: 70 other events
Deaths: 0 deaths
Control
Serious events: 11 serious events
Other events: 56 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TactiCath
n=152 participants at risk
Ablation performed using the TactiCath contact force sensing catheter
Catheter ablation for the treatment of paroxysmal atrial fibrillation: A pulmonary vein isolation procedure will be performed using radiofrequency ablation.
|
Control
n=143 participants at risk
Ablation performed using a catheter with no contact force sensing capability
Catheter ablation for the treatment of paroxysmal atrial fibrillation: A pulmonary vein isolation procedure will be performed using radiofrequency ablation.
|
|---|---|---|
|
Cardiac disorders
Cardiac perforation
|
0.66%
1/152 • Number of events 1 • 12 months
The Safety analysis population excludes 5 subjects who signed consent and were randomized but were not exposed to the study procedure or the study device resulting in n=295 subjects. 3 subjects were excluded from the TactiCath group resulting in n=152 subjects 2 subjects excluded from the Control group resulting in n=143 subjects
|
0.00%
0/143 • 12 months
The Safety analysis population excludes 5 subjects who signed consent and were randomized but were not exposed to the study procedure or the study device resulting in n=295 subjects. 3 subjects were excluded from the TactiCath group resulting in n=152 subjects 2 subjects excluded from the Control group resulting in n=143 subjects
|
|
Cardiac disorders
Atrial Perforation
|
0.00%
0/152 • 12 months
The Safety analysis population excludes 5 subjects who signed consent and were randomized but were not exposed to the study procedure or the study device resulting in n=295 subjects. 3 subjects were excluded from the TactiCath group resulting in n=152 subjects 2 subjects excluded from the Control group resulting in n=143 subjects
|
0.70%
1/143 • Number of events 1 • 12 months
The Safety analysis population excludes 5 subjects who signed consent and were randomized but were not exposed to the study procedure or the study device resulting in n=295 subjects. 3 subjects were excluded from the TactiCath group resulting in n=152 subjects 2 subjects excluded from the Control group resulting in n=143 subjects
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
1.3%
2/152 • Number of events 2 • 12 months
The Safety analysis population excludes 5 subjects who signed consent and were randomized but were not exposed to the study procedure or the study device resulting in n=295 subjects. 3 subjects were excluded from the TactiCath group resulting in n=152 subjects 2 subjects excluded from the Control group resulting in n=143 subjects
|
1.4%
2/143 • Number of events 2 • 12 months
The Safety analysis population excludes 5 subjects who signed consent and were randomized but were not exposed to the study procedure or the study device resulting in n=295 subjects. 3 subjects were excluded from the TactiCath group resulting in n=152 subjects 2 subjects excluded from the Control group resulting in n=143 subjects
|
|
Vascular disorders
Vascular Access Complication
|
2.0%
3/152 • Number of events 3 • 12 months
The Safety analysis population excludes 5 subjects who signed consent and were randomized but were not exposed to the study procedure or the study device resulting in n=295 subjects. 3 subjects were excluded from the TactiCath group resulting in n=152 subjects 2 subjects excluded from the Control group resulting in n=143 subjects
|
2.1%
3/143 • Number of events 3 • 12 months
The Safety analysis population excludes 5 subjects who signed consent and were randomized but were not exposed to the study procedure or the study device resulting in n=295 subjects. 3 subjects were excluded from the TactiCath group resulting in n=152 subjects 2 subjects excluded from the Control group resulting in n=143 subjects
|
|
General disorders
Hospitalization
|
2.6%
4/152 • Number of events 4 • 12 months
The Safety analysis population excludes 5 subjects who signed consent and were randomized but were not exposed to the study procedure or the study device resulting in n=295 subjects. 3 subjects were excluded from the TactiCath group resulting in n=152 subjects 2 subjects excluded from the Control group resulting in n=143 subjects
|
3.5%
5/143 • Number of events 5 • 12 months
The Safety analysis population excludes 5 subjects who signed consent and were randomized but were not exposed to the study procedure or the study device resulting in n=295 subjects. 3 subjects were excluded from the TactiCath group resulting in n=152 subjects 2 subjects excluded from the Control group resulting in n=143 subjects
|
Other adverse events
| Measure |
TactiCath
n=152 participants at risk
Ablation performed using the TactiCath contact force sensing catheter
Catheter ablation for the treatment of paroxysmal atrial fibrillation: A pulmonary vein isolation procedure will be performed using radiofrequency ablation.
|
Control
n=143 participants at risk
Ablation performed using a catheter with no contact force sensing capability
Catheter ablation for the treatment of paroxysmal atrial fibrillation: A pulmonary vein isolation procedure will be performed using radiofrequency ablation.
|
|---|---|---|
|
Cardiac disorders
Cardiac disorders
|
25.0%
38/152 • Number of events 75 • 12 months
The Safety analysis population excludes 5 subjects who signed consent and were randomized but were not exposed to the study procedure or the study device resulting in n=295 subjects. 3 subjects were excluded from the TactiCath group resulting in n=152 subjects 2 subjects excluded from the Control group resulting in n=143 subjects
|
25.2%
36/143 • Number of events 59 • 12 months
The Safety analysis population excludes 5 subjects who signed consent and were randomized but were not exposed to the study procedure or the study device resulting in n=295 subjects. 3 subjects were excluded from the TactiCath group resulting in n=152 subjects 2 subjects excluded from the Control group resulting in n=143 subjects
|
|
Vascular disorders
Vascular disorders
|
11.2%
17/152 • Number of events 20 • 12 months
The Safety analysis population excludes 5 subjects who signed consent and were randomized but were not exposed to the study procedure or the study device resulting in n=295 subjects. 3 subjects were excluded from the TactiCath group resulting in n=152 subjects 2 subjects excluded from the Control group resulting in n=143 subjects
|
6.3%
9/143 • Number of events 9 • 12 months
The Safety analysis population excludes 5 subjects who signed consent and were randomized but were not exposed to the study procedure or the study device resulting in n=295 subjects. 3 subjects were excluded from the TactiCath group resulting in n=152 subjects 2 subjects excluded from the Control group resulting in n=143 subjects
|
|
Respiratory, thoracic and mediastinal disorders
Repiratory, thoracic and mediastinal disorders
|
7.2%
11/152 • Number of events 11 • 12 months
The Safety analysis population excludes 5 subjects who signed consent and were randomized but were not exposed to the study procedure or the study device resulting in n=295 subjects. 3 subjects were excluded from the TactiCath group resulting in n=152 subjects 2 subjects excluded from the Control group resulting in n=143 subjects
|
2.1%
3/143 • Number of events 3 • 12 months
The Safety analysis population excludes 5 subjects who signed consent and were randomized but were not exposed to the study procedure or the study device resulting in n=295 subjects. 3 subjects were excluded from the TactiCath group resulting in n=152 subjects 2 subjects excluded from the Control group resulting in n=143 subjects
|
|
General disorders
General disorders
|
3.9%
6/152 • Number of events 6 • 12 months
The Safety analysis population excludes 5 subjects who signed consent and were randomized but were not exposed to the study procedure or the study device resulting in n=295 subjects. 3 subjects were excluded from the TactiCath group resulting in n=152 subjects 2 subjects excluded from the Control group resulting in n=143 subjects
|
4.9%
7/143 • Number of events 8 • 12 months
The Safety analysis population excludes 5 subjects who signed consent and were randomized but were not exposed to the study procedure or the study device resulting in n=295 subjects. 3 subjects were excluded from the TactiCath group resulting in n=152 subjects 2 subjects excluded from the Control group resulting in n=143 subjects
|
|
Investigations
Investigations
|
3.9%
6/152 • Number of events 6 • 12 months
The Safety analysis population excludes 5 subjects who signed consent and were randomized but were not exposed to the study procedure or the study device resulting in n=295 subjects. 3 subjects were excluded from the TactiCath group resulting in n=152 subjects 2 subjects excluded from the Control group resulting in n=143 subjects
|
4.2%
6/143 • Number of events 8 • 12 months
The Safety analysis population excludes 5 subjects who signed consent and were randomized but were not exposed to the study procedure or the study device resulting in n=295 subjects. 3 subjects were excluded from the TactiCath group resulting in n=152 subjects 2 subjects excluded from the Control group resulting in n=143 subjects
|
|
Nervous system disorders
Nervous systems disorders
|
4.6%
7/152 • Number of events 7 • 12 months
The Safety analysis population excludes 5 subjects who signed consent and were randomized but were not exposed to the study procedure or the study device resulting in n=295 subjects. 3 subjects were excluded from the TactiCath group resulting in n=152 subjects 2 subjects excluded from the Control group resulting in n=143 subjects
|
1.4%
2/143 • Number of events 4 • 12 months
The Safety analysis population excludes 5 subjects who signed consent and were randomized but were not exposed to the study procedure or the study device resulting in n=295 subjects. 3 subjects were excluded from the TactiCath group resulting in n=152 subjects 2 subjects excluded from the Control group resulting in n=143 subjects
|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
2.6%
4/152 • Number of events 4 • 12 months
The Safety analysis population excludes 5 subjects who signed consent and were randomized but were not exposed to the study procedure or the study device resulting in n=295 subjects. 3 subjects were excluded from the TactiCath group resulting in n=152 subjects 2 subjects excluded from the Control group resulting in n=143 subjects
|
2.8%
4/143 • Number of events 5 • 12 months
The Safety analysis population excludes 5 subjects who signed consent and were randomized but were not exposed to the study procedure or the study device resulting in n=295 subjects. 3 subjects were excluded from the TactiCath group resulting in n=152 subjects 2 subjects excluded from the Control group resulting in n=143 subjects
|
|
Renal and urinary disorders
Renal and urinary disorders
|
2.6%
4/152 • Number of events 4 • 12 months
The Safety analysis population excludes 5 subjects who signed consent and were randomized but were not exposed to the study procedure or the study device resulting in n=295 subjects. 3 subjects were excluded from the TactiCath group resulting in n=152 subjects 2 subjects excluded from the Control group resulting in n=143 subjects
|
2.8%
4/143 • Number of events 4 • 12 months
The Safety analysis population excludes 5 subjects who signed consent and were randomized but were not exposed to the study procedure or the study device resulting in n=295 subjects. 3 subjects were excluded from the TactiCath group resulting in n=152 subjects 2 subjects excluded from the Control group resulting in n=143 subjects
|
|
Infections and infestations
Infection and infestations
|
2.6%
4/152 • Number of events 4 • 12 months
The Safety analysis population excludes 5 subjects who signed consent and were randomized but were not exposed to the study procedure or the study device resulting in n=295 subjects. 3 subjects were excluded from the TactiCath group resulting in n=152 subjects 2 subjects excluded from the Control group resulting in n=143 subjects
|
1.4%
2/143 • Number of events 2 • 12 months
The Safety analysis population excludes 5 subjects who signed consent and were randomized but were not exposed to the study procedure or the study device resulting in n=295 subjects. 3 subjects were excluded from the TactiCath group resulting in n=152 subjects 2 subjects excluded from the Control group resulting in n=143 subjects
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications
|
1.3%
2/152 • Number of events 2 • 12 months
The Safety analysis population excludes 5 subjects who signed consent and were randomized but were not exposed to the study procedure or the study device resulting in n=295 subjects. 3 subjects were excluded from the TactiCath group resulting in n=152 subjects 2 subjects excluded from the Control group resulting in n=143 subjects
|
2.1%
3/143 • Number of events 3 • 12 months
The Safety analysis population excludes 5 subjects who signed consent and were randomized but were not exposed to the study procedure or the study device resulting in n=295 subjects. 3 subjects were excluded from the TactiCath group resulting in n=152 subjects 2 subjects excluded from the Control group resulting in n=143 subjects
|
|
Musculoskeletal and connective tissue disorders
Muskuloskeletal and connective disorders
|
1.3%
2/152 • Number of events 2 • 12 months
The Safety analysis population excludes 5 subjects who signed consent and were randomized but were not exposed to the study procedure or the study device resulting in n=295 subjects. 3 subjects were excluded from the TactiCath group resulting in n=152 subjects 2 subjects excluded from the Control group resulting in n=143 subjects
|
1.4%
2/143 • Number of events 2 • 12 months
The Safety analysis population excludes 5 subjects who signed consent and were randomized but were not exposed to the study procedure or the study device resulting in n=295 subjects. 3 subjects were excluded from the TactiCath group resulting in n=152 subjects 2 subjects excluded from the Control group resulting in n=143 subjects
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders
|
0.00%
0/152 • 12 months
The Safety analysis population excludes 5 subjects who signed consent and were randomized but were not exposed to the study procedure or the study device resulting in n=295 subjects. 3 subjects were excluded from the TactiCath group resulting in n=152 subjects 2 subjects excluded from the Control group resulting in n=143 subjects
|
2.1%
3/143 • Number of events 3 • 12 months
The Safety analysis population excludes 5 subjects who signed consent and were randomized but were not exposed to the study procedure or the study device resulting in n=295 subjects. 3 subjects were excluded from the TactiCath group resulting in n=152 subjects 2 subjects excluded from the Control group resulting in n=143 subjects
|
|
Eye disorders
Eye disorders
|
0.00%
0/152 • 12 months
The Safety analysis population excludes 5 subjects who signed consent and were randomized but were not exposed to the study procedure or the study device resulting in n=295 subjects. 3 subjects were excluded from the TactiCath group resulting in n=152 subjects 2 subjects excluded from the Control group resulting in n=143 subjects
|
1.4%
2/143 • Number of events 4 • 12 months
The Safety analysis population excludes 5 subjects who signed consent and were randomized but were not exposed to the study procedure or the study device resulting in n=295 subjects. 3 subjects were excluded from the TactiCath group resulting in n=152 subjects 2 subjects excluded from the Control group resulting in n=143 subjects
|
|
Immune system disorders
Immune system disorders
|
0.66%
1/152 • Number of events 1 • 12 months
The Safety analysis population excludes 5 subjects who signed consent and were randomized but were not exposed to the study procedure or the study device resulting in n=295 subjects. 3 subjects were excluded from the TactiCath group resulting in n=152 subjects 2 subjects excluded from the Control group resulting in n=143 subjects
|
0.70%
1/143 • Number of events 1 • 12 months
The Safety analysis population excludes 5 subjects who signed consent and were randomized but were not exposed to the study procedure or the study device resulting in n=295 subjects. 3 subjects were excluded from the TactiCath group resulting in n=152 subjects 2 subjects excluded from the Control group resulting in n=143 subjects
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders
|
1.3%
2/152 • Number of events 2 • 12 months
The Safety analysis population excludes 5 subjects who signed consent and were randomized but were not exposed to the study procedure or the study device resulting in n=295 subjects. 3 subjects were excluded from the TactiCath group resulting in n=152 subjects 2 subjects excluded from the Control group resulting in n=143 subjects
|
0.00%
0/143 • 12 months
The Safety analysis population excludes 5 subjects who signed consent and were randomized but were not exposed to the study procedure or the study device resulting in n=295 subjects. 3 subjects were excluded from the TactiCath group resulting in n=152 subjects 2 subjects excluded from the Control group resulting in n=143 subjects
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders
|
0.00%
0/152 • 12 months
The Safety analysis population excludes 5 subjects who signed consent and were randomized but were not exposed to the study procedure or the study device resulting in n=295 subjects. 3 subjects were excluded from the TactiCath group resulting in n=152 subjects 2 subjects excluded from the Control group resulting in n=143 subjects
|
0.70%
1/143 • Number of events 1 • 12 months
The Safety analysis population excludes 5 subjects who signed consent and were randomized but were not exposed to the study procedure or the study device resulting in n=295 subjects. 3 subjects were excluded from the TactiCath group resulting in n=152 subjects 2 subjects excluded from the Control group resulting in n=143 subjects
|
|
Endocrine disorders
Endocrine disorders
|
0.00%
0/152 • 12 months
The Safety analysis population excludes 5 subjects who signed consent and were randomized but were not exposed to the study procedure or the study device resulting in n=295 subjects. 3 subjects were excluded from the TactiCath group resulting in n=152 subjects 2 subjects excluded from the Control group resulting in n=143 subjects
|
0.70%
1/143 • Number of events 1 • 12 months
The Safety analysis population excludes 5 subjects who signed consent and were randomized but were not exposed to the study procedure or the study device resulting in n=295 subjects. 3 subjects were excluded from the TactiCath group resulting in n=152 subjects 2 subjects excluded from the Control group resulting in n=143 subjects
|
|
Psychiatric disorders
Psychiatric disorders
|
0.00%
0/152 • 12 months
The Safety analysis population excludes 5 subjects who signed consent and were randomized but were not exposed to the study procedure or the study device resulting in n=295 subjects. 3 subjects were excluded from the TactiCath group resulting in n=152 subjects 2 subjects excluded from the Control group resulting in n=143 subjects
|
0.70%
1/143 • Number of events 1 • 12 months
The Safety analysis population excludes 5 subjects who signed consent and were randomized but were not exposed to the study procedure or the study device resulting in n=295 subjects. 3 subjects were excluded from the TactiCath group resulting in n=152 subjects 2 subjects excluded from the Control group resulting in n=143 subjects
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders
|
0.66%
1/152 • Number of events 1 • 12 months
The Safety analysis population excludes 5 subjects who signed consent and were randomized but were not exposed to the study procedure or the study device resulting in n=295 subjects. 3 subjects were excluded from the TactiCath group resulting in n=152 subjects 2 subjects excluded from the Control group resulting in n=143 subjects
|
0.00%
0/143 • 12 months
The Safety analysis population excludes 5 subjects who signed consent and were randomized but were not exposed to the study procedure or the study device resulting in n=295 subjects. 3 subjects were excluded from the TactiCath group resulting in n=152 subjects 2 subjects excluded from the Control group resulting in n=143 subjects
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60