Trial Outcomes & Findings for A Study For Treatment of Paroxysmal Atrial Fibrillation (PAF) With the OMNYPULSE Catheter and the TRUPULSE Generator (NCT NCT05971693)
NCT ID: NCT05971693
Last Updated: 2026-03-25
Results Overview
Percentage of participants with PAEs was reported. PAEs (within seven \[7\] days of the index ablation procedure) included the following adverse events atrio-esophageal fistula, pulmonary vein stenosis, device or procedure related death, (up to 90 days post-procedure), phrenic nerve paralysis (permanent), cardiac tamponade/perforation (up to 30 days post-procedure), stroke/cerebrovascular accident (CVA), major vascular access complication, major bleeding, thromboembolism, myocardial infarction, transient ischemic attack (TIA), pericarditis, heart block, pulmonary edema (respiratory insufficiency), and vagal nerve injury/gastroparesis.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
188 participants
Primary outcome timeframe
90 days post catheter insertion on Day 0
Results posted on
2026-03-25
Participant Flow
A total of 188 participants who signed the informed consent form (ICF) were enrolled in the study. Out of 188, 11 participants who never underwent insertion of the study catheter were excluded, result for 177 evaluable participants (who had the study catheter inserted) is reported.
Results are currently reported until the primary completion date (10-Dec-2024). Remaining results will be posted upon study completion.
Participant milestones
| Measure |
Roll-In Analysis Set: OMNYPULSE Bi-Directional Catheter With TRUPULSE Generator
Participants enrolled in the roll-in phase with symptomatic paroxysmal atrial fibrillation (PAF) who were candidates for catheter ablation were enrolled and treated with OMNYPULSE bi-directional catheter in combination with the TRUPULSE generator for pulmonary vein isolation (PVI).
|
Main Safety Analysis Set: OMNYPULSE Bi-Directional Catheter With TRUPULSE Generator
Participants enrolled in the main phase with symptomatic PAF who were candidates for catheter ablation were enrolled and treated with OMNYPULSE bi-directional catheter in combination with the TRUPULSE generator for PVI.
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
136
|
|
Overall Study
COMPLETED
|
13
|
20
|
|
Overall Study
NOT COMPLETED
|
28
|
116
|
Reasons for withdrawal
| Measure |
Roll-In Analysis Set: OMNYPULSE Bi-Directional Catheter With TRUPULSE Generator
Participants enrolled in the roll-in phase with symptomatic paroxysmal atrial fibrillation (PAF) who were candidates for catheter ablation were enrolled and treated with OMNYPULSE bi-directional catheter in combination with the TRUPULSE generator for pulmonary vein isolation (PVI).
|
Main Safety Analysis Set: OMNYPULSE Bi-Directional Catheter With TRUPULSE Generator
Participants enrolled in the main phase with symptomatic PAF who were candidates for catheter ablation were enrolled and treated with OMNYPULSE bi-directional catheter in combination with the TRUPULSE generator for PVI.
|
|---|---|---|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
|
Overall Study
Ongoing
|
25
|
115
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Roll-In Analysis Set: OMNYPULSE Bi-Directional Catheter With TRUPULSE Generator
n=41 Participants
Participants enrolled in the roll-in phase with symptomatic paroxysmal atrial fibrillation (PAF) who were candidates for catheter ablation were enrolled and treated with OMNYPULSE bi-directional catheter in combination with the TRUPULSE generator for pulmonary vein isolation (PVI).
|
Main Safety Analysis Set: OMNYPULSE Bi-Directional Catheter With TRUPULSE Generator
n=136 Participants
Participants enrolled in the main phase with symptomatic PAF who were candidates for catheter ablation were enrolled and treated with OMNYPULSE bi-directional catheter in combination with the TRUPULSE generator for PVI.
|
Total
n=177 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.4 Years
STANDARD_DEVIATION 11.20 • n=41 Participants
|
59.8 Years
STANDARD_DEVIATION 9.55 • n=136 Participants
|
60.2 Years
STANDARD_DEVIATION 9.94 • n=177 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=41 Participants
|
42 Participants
n=136 Participants
|
58 Participants
n=177 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=41 Participants
|
94 Participants
n=136 Participants
|
119 Participants
n=177 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 90 days post catheter insertion on Day 0Population: Modified intention-to-treat (mITT) analysis set included all enrolled participants who met eligibility criteria and had insertion of the study catheter. Here, 'N' (overall number of participants analyzed) refers to participants who were evaluable for this outcome measure.
Percentage of participants with PAEs was reported. PAEs (within seven \[7\] days of the index ablation procedure) included the following adverse events atrio-esophageal fistula, pulmonary vein stenosis, device or procedure related death, (up to 90 days post-procedure), phrenic nerve paralysis (permanent), cardiac tamponade/perforation (up to 30 days post-procedure), stroke/cerebrovascular accident (CVA), major vascular access complication, major bleeding, thromboembolism, myocardial infarction, transient ischemic attack (TIA), pericarditis, heart block, pulmonary edema (respiratory insufficiency), and vagal nerve injury/gastroparesis.
Outcome measures
| Measure |
Roll-In Analysis Set: OMNYPULSE Bi-Directional Catheter With TRUPULSE Generator
n=40 Participants
Participants enrolled in the roll-in phase with symptomatic paroxysmal atrial fibrillation (PAF) who were candidates for catheter ablation were enrolled and treated with OMNYPULSE bi-directional catheter in combination with the TRUPULSE generator for pulmonary vein isolation (PVI).
|
Main Safety Analysis Set: OMNYPULSE Bi-Directional Catheter With TRUPULSE Generator
n=135 Participants
Participants enrolled in the main phase with symptomatic PAF who were candidates for catheter ablation were enrolled and treated with OMNYPULSE bi-directional catheter in combination with the TRUPULSE generator for PVI.
|
|---|---|---|
|
Percentage of Participants With Primary Adverse Events (PAEs)
Death (Device or procedure related)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Primary Adverse Events (PAEs)
Major Vascular Access Complication
|
2.5 Percentage of participants
|
2.2 Percentage of participants
|
|
Percentage of Participants With Primary Adverse Events (PAEs)
Major Bleeding
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Primary Adverse Events (PAEs)
Myocardial Infarction
|
2.5 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Primary Adverse Events (PAEs)
Transient Ischemic Attack (TIA)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Primary Adverse Events (PAEs)
Phrenic Nerve Paralysis
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Primary Adverse Events (PAEs)
Pulmonary Vein Stenosis
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Primary Adverse Events (PAEs)
Atrio-Esophageal Fistula
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Primary Adverse Events (PAEs)
Cardiac Tamponade/ Perforation
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Primary Adverse Events (PAEs)
Heart Block
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Primary Adverse Events (PAEs)
Stroke/Cerebrovascular Accident (CVA)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Primary Adverse Events (PAEs)
Thromboembolism
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Primary Adverse Events (PAEs)
Pulmonary Edema (Respiratory Insufficiency)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Primary Adverse Events (PAEs)
Pericarditis
|
0 Percentage of participants
|
0.7 Percentage of participants
|
|
Percentage of Participants With Primary Adverse Events (PAEs)
Vagal Nerve injury/ Gastroparesis
|
0 Percentage of participants
|
0 Percentage of participants
|
PRIMARY outcome
Timeframe: Immediately post-procedure on Day 0 (post catheter insertion)Population: Per Protocol Analysis set included participants who had undergone ablation using PF energy via the investigational ablation system, were treated for study-related arrhythmia, and were enrolled and without major protocol deviations that would affect the scientific integrity of the safety and effectiveness data. Here, 'N' (overall number of participants analyzed) refers to participants who were evaluable.
Percentage of participants with acute effectiveness success were reported. Procedural success was defined as electrical isolation of clinically relevant targeted pulmonary veins (PV; confirmed by entrance block) after adenosine/isoproterenol challenge at the end of the index ablation procedure.
Outcome measures
| Measure |
Roll-In Analysis Set: OMNYPULSE Bi-Directional Catheter With TRUPULSE Generator
n=41 Participants
Participants enrolled in the roll-in phase with symptomatic paroxysmal atrial fibrillation (PAF) who were candidates for catheter ablation were enrolled and treated with OMNYPULSE bi-directional catheter in combination with the TRUPULSE generator for pulmonary vein isolation (PVI).
|
Main Safety Analysis Set: OMNYPULSE Bi-Directional Catheter With TRUPULSE Generator
n=136 Participants
Participants enrolled in the main phase with symptomatic PAF who were candidates for catheter ablation were enrolled and treated with OMNYPULSE bi-directional catheter in combination with the TRUPULSE generator for PVI.
|
|---|---|---|
|
Percentage of Participants With Acute Effectiveness Success
|
100 Percentage of participants
|
100 Percentage of participants
|
SECONDARY outcome
Timeframe: From Day 91 to Day 365 post catheter insertion on Day 0Outcome measures
Outcome data not reported
Adverse Events
Roll-In Analysis Set: OMNYPULSE Bi-Directional Catheter With TRUPULSE Generator
Serious events: 5 serious events
Other events: 20 other events
Deaths: 1 deaths
Main Safety Analysis Set: OMNYPULSE Bi-Directional Catheter With TRUPULSE Generator
Serious events: 10 serious events
Other events: 71 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Roll-In Analysis Set: OMNYPULSE Bi-Directional Catheter With TRUPULSE Generator
n=41 participants at risk
Participants enrolled in the roll-in phase with symptomatic paroxysmal atrial fibrillation (PAF) who were candidates for catheter ablation were enrolled and treated with OMNYPULSE bi-directional catheter in combination with the TRUPULSE generator for pulmonary vein isolation (PVI).
|
Main Safety Analysis Set: OMNYPULSE Bi-Directional Catheter With TRUPULSE Generator
n=136 participants at risk
Participants enrolled in the main phase with symptomatic PAF who were candidates for catheter ablation were enrolled and treated with OMNYPULSE bi-directional catheter in combination with the TRUPULSE generator for PVI.
|
|---|---|---|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.74%
1/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Nervous system disorders
Migraine
|
0.00%
0/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.74%
1/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Nervous system disorders
Migraine with aura
|
0.00%
0/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.74%
1/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.74%
1/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Cardiac disorders
Atrial tachycardia
|
0.00%
0/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.74%
1/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Cardiac disorders
Cardiomyopathy
|
2.4%
1/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.00%
0/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Cardiac disorders
Myocardial infarction
|
2.4%
1/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.00%
0/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
General disorders
Pyrexia
|
0.00%
0/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.74%
1/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
General disorders
Sense of oppression
|
0.00%
0/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.74%
1/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.00%
0/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.74%
1/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm thrombosis
|
0.00%
0/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.74%
1/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Injury, poisoning and procedural complications
Airway complication of anaesthesia
|
2.4%
1/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.00%
0/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.74%
1/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Hepatobiliary disorders
Cholecystitis
|
2.4%
1/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.00%
0/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Hepatobiliary disorders
Cholelithiasis
|
2.4%
1/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.00%
0/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Vascular disorders
Haematoma
|
2.4%
1/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.00%
0/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
Other adverse events
| Measure |
Roll-In Analysis Set: OMNYPULSE Bi-Directional Catheter With TRUPULSE Generator
n=41 participants at risk
Participants enrolled in the roll-in phase with symptomatic paroxysmal atrial fibrillation (PAF) who were candidates for catheter ablation were enrolled and treated with OMNYPULSE bi-directional catheter in combination with the TRUPULSE generator for pulmonary vein isolation (PVI).
|
Main Safety Analysis Set: OMNYPULSE Bi-Directional Catheter With TRUPULSE Generator
n=136 participants at risk
Participants enrolled in the main phase with symptomatic PAF who were candidates for catheter ablation were enrolled and treated with OMNYPULSE bi-directional catheter in combination with the TRUPULSE generator for PVI.
|
|---|---|---|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.74%
1/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.74%
1/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Gastrointestinal disorders
Lip swelling
|
0.00%
0/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.74%
1/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Cardiac disorders
Palpitations
|
4.9%
2/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
6.6%
9/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
5.1%
7/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Cardiac disorders
Bradycardia
|
2.4%
1/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.74%
1/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
1.5%
2/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
1.5%
2/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
1.5%
2/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Cardiac disorders
Atrial tachycardia
|
4.9%
2/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.74%
1/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Cardiac disorders
Supraventricular extrasystoles
|
2.4%
1/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.74%
1/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.74%
1/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Cardiac disorders
Atrial thrombosis
|
2.4%
1/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.00%
0/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Cardiac disorders
Coronary artery stenosis
|
2.4%
1/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.00%
0/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Gastrointestinal disorders
Dyspepsia
|
4.9%
2/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.00%
0/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
General disorders
Adverse drug reaction
|
2.4%
1/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.00%
0/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
General disorders
Chest pain
|
2.4%
1/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
1.5%
2/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
General disorders
Puncture site pain
|
2.4%
1/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.00%
0/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Renal and urinary disorders
Urinary retention
|
4.9%
2/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.00%
0/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Injury, poisoning and procedural complications
Vascular access site haemorrhage
|
4.9%
2/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
6.6%
9/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Renal and urinary disorders
Dysuria
|
2.4%
1/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.00%
0/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Vascular disorders
Hypertension
|
4.9%
2/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
2.9%
4/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Vascular disorders
Hypotension
|
2.4%
1/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
1.5%
2/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.74%
1/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Infections and infestations
Influenza
|
0.00%
0/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.74%
1/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.74%
1/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
General disorders
Oedema peripheral
|
0.00%
0/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.74%
1/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
2.4%
1/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
2.2%
3/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
General disorders
Pyrexia
|
0.00%
0/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.74%
1/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.00%
0/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.74%
1/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Ear and labyrinth disorders
Middle ear effusion
|
0.00%
0/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.74%
1/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.74%
1/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Ear and labyrinth disorders
Vestibular disorder
|
0.00%
0/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.74%
1/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Investigations
Blood pressure increased
|
0.00%
0/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.74%
1/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Investigations
Heart rate irregular
|
0.00%
0/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.74%
1/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.74%
1/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
2.4%
1/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
1.5%
2/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.74%
1/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Infections and infestations
Cystitis
|
4.9%
2/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.74%
1/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Infections and infestations
COVID-19
|
4.9%
2/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.74%
1/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Infections and infestations
Erysipelas
|
2.4%
1/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.00%
0/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Infections and infestations
Nasopharyngitis
|
2.4%
1/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.74%
1/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Infections and infestations
Sinusitis
|
2.4%
1/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.00%
0/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Infections and infestations
Skin infection
|
2.4%
1/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.00%
0/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Infections and infestations
Vaginal infection
|
2.4%
1/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.00%
0/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Infections and infestations
Wound infection
|
2.4%
1/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.00%
0/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.74%
1/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
0.00%
0/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.74%
1/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Injury, poisoning and procedural complications
Incision site haemorrhage
|
0.00%
0/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.74%
1/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.74%
1/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Injury, poisoning and procedural complications
Post ablation syndrome
|
0.00%
0/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.74%
1/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Injury, poisoning and procedural complications
Vascular access site pain
|
0.00%
0/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.74%
1/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.00%
0/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.74%
1/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Injury, poisoning and procedural complications
Bone contusion
|
2.4%
1/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.00%
0/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Injury, poisoning and procedural complications
Eye contusion
|
2.4%
1/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.00%
0/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
2.4%
1/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.00%
0/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Injury, poisoning and procedural complications
Sedation complication
|
2.4%
1/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.00%
0/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Gastrointestinal disorders
Nausea
|
2.4%
1/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
4.4%
6/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
1.5%
2/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
1.5%
2/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Gastrointestinal disorders
Oesophageal irritation
|
0.00%
0/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
1.5%
2/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.74%
1/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.74%
1/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Gastrointestinal disorders
Barrett's oesophagus
|
0.00%
0/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.74%
1/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.74%
1/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Gastrointestinal disorders
Erosive oesophagitis
|
0.00%
0/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.74%
1/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Gastrointestinal disorders
Gastritis
|
2.4%
1/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.74%
1/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.3%
3/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
2.9%
4/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
4.9%
2/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
4.4%
6/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
2.4%
1/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.00%
0/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
2.4%
1/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.00%
0/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
2.4%
1/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.74%
1/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Musculoskeletal and connective tissue disorders
Sacroiliac joint dysfunction
|
2.4%
1/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.00%
0/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
2.4%
1/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.00%
0/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Musculoskeletal and connective tissue disorders
Vertebral foraminal stenosis
|
2.4%
1/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.00%
0/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
1.5%
2/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.74%
1/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Musculoskeletal and connective tissue disorders
Chondropathy
|
0.00%
0/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.74%
1/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.74%
1/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Nervous system disorders
Headache
|
0.00%
0/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
3.7%
5/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Nervous system disorders
Migraine
|
2.4%
1/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
2.2%
3/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Nervous system disorders
Dizziness
|
4.9%
2/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
1.5%
2/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.74%
1/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Nervous system disorders
Central nervous system lesion
|
0.00%
0/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.74%
1/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.74%
1/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.74%
1/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.74%
1/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Nervous system disorders
Migraine with aura
|
0.00%
0/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.74%
1/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.74%
1/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Blood and lymphatic system disorders
Intravascular haemolysis
|
4.9%
2/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.00%
0/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Endocrine disorders
Hypothyroidism
|
2.4%
1/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.00%
0/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Hepatobiliary disorders
Gallbladder disorder
|
2.4%
1/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.00%
0/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
2.4%
1/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.00%
0/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Psychiatric disorders
Insomnia
|
2.4%
1/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.00%
0/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Vascular disorders
Haematoma
|
0.00%
0/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
2.9%
4/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.74%
1/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.74%
1/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.74%
1/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.74%
1/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Infections and infestations
Ear infection
|
0.00%
0/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.74%
1/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Infections and infestations
Respiratory tract infection
|
2.4%
1/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.74%
1/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.74%
1/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.74%
1/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
2.9%
4/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
2.2%
3/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
1.5%
2/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.74%
1/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.74%
1/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
General disorders
Fatigue
|
0.00%
0/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
1.5%
2/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
General disorders
Exercise tolerance decreased
|
0.00%
0/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.74%
1/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.74%
1/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Investigations
Monoclonal immunoglobulin increased
|
0.00%
0/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.74%
1/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Investigations
Prostatic specific antigen increased
|
0.00%
0/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.74%
1/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Eye disorders
Astigmatism
|
0.00%
0/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.74%
1/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Eye disorders
Retinopathy
|
0.00%
0/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.74%
1/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.74%
1/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Blood and lymphatic system disorders
Lymphadenopathy mediastinal
|
0.00%
0/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.74%
1/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Congenital, familial and genetic disorders
Ectopic posterior pituitary gland
|
0.00%
0/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.74%
1/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.74%
1/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Psychiatric disorders
Depression
|
0.00%
0/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.74%
1/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.74%
1/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.00%
0/41 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
0.74%
1/136 • From date of signing ICF (Day -60) up to 12 months
Safety analysis set included all the enrolled participants who had insertion of the study catheter, regardless of energy delivery.
|
Additional Information
Executive Medical Director
Janssen Research and Development, LLC
Phone: 844-434-4210
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
- Publication restrictions are in place
Restriction type: OTHER