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A Study for Treatment of Paroxysmal Atrial Fibrillation (PAF) by Pulsed Field Ablation (PFA) System With Irreversible Electroporation (IRE) (inspIRE)

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ClinicalTrials.gov Identifier: NCT04524364
Recruitment Status : Completed
First Posted : August 24, 2020
Results First Posted : May 14, 2024
Last Update Posted : May 14, 2024
Sponsor:
Information provided by (Responsible Party):
Biosense Webster, Inc.

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Atrial Fibrillation
Intervention Device: Pulsed Field Ablation (PFA) Therapy
Enrollment 272
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Wave I Wave II
Hide Arm/Group Description Participants with drug refractory, symptomatic pulse field ablation (PAF) who were candidates for catheter ablation, underwent the index procedure and additional neurological, pulmonary vein (PV) and esophageal assessments to obtain data for preliminary estimates of safety and (acute) effectiveness of the irreversible electroporation (IRE) ablation system. Participants were enrolled in Wave II (Wave II main phase or Wave II roll-in) and treated with the Circular IRE Catheter in conjunction with the IRE Generator.
Period Title: Overall Study
Started 45 227
Treated 40 216
Wave II: Main Phase Full Analysis Set 0 186
Wave II: Roll-in Analysis Set (RI AS) 0 30
Completed 40 216
Not Completed 5 11
Reason Not Completed
Physician Decision             3             6
Adverse Event             0             1
Investigational device deficiency             0             1
Implantable cardioverter device (ICD) discovered             0             1
Device unavailability             0             2
Atrio-ventricular Paroxysmal tachycardia requiring ablation outside PV             1             0
Low International normalized ratio (INR)             1             0
Arm/Group Title Wave I Wave II: Main Phase Wave II: Roll-In Total
Hide Arm/Group Description Participants with drug refractory, symptomatic pulse field ablation (PAF) who were candidates for catheter ablation, underwent the index procedure and additional neurological, pulmonary vein (PV) and esophageal assessments to obtain data for preliminary estimates of safety and (acute) effectiveness of the irreversible electroporation (IRE) ablation system. Participants enrolled in Wave II main phase, were treated with the Circular IRE Catheter in conjunction with the IRE Generator. Participants enrolled in Wave II roll-in, were treated with the Circular IRE Catheter in conjunction with the IRE Generator. Total of all reporting groups
Overall Number of Baseline Participants 40 186 30 256
Hide Baseline Analysis Population Description
Baseline characteristics were based on the full analysis set (FAS) for Wave I and Wave II (main phase) arms and the roll-in analysis set (RI AS) for the Wave II (roll-in) arm. FAS included all enrolled Wave I and Wave II (main phase) participants who had insertion of the study catheter (with or without delivery of PFA). The RI AS included all Wave II (roll-in) participants who were enrolled in the roll-in phase and underwent ablation with the irreversible electroporation (IRE) ablation system.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants 186 participants 30 participants 256 participants
58.4  (10.86) 59.4  (10.18) 56.2  (11.72) 58.0  (10.92)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 186 participants 30 participants 256 participants
Female
17
  42.5%
55
  29.6%
10
  33.3%
82
  32.0%
Male
23
  57.5%
131
  70.4%
20
  66.7%
174
  68.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
1.Primary Outcome
Title Number of Participants With Primary Adverse Events (PAEs)
Hide Description An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. The primary safety endpoint was the incidence of PAEs (within 7 days of the initial mapping and ablation procedure). PAEs included the following AEs: Atrio-esophageal fistula, cardiac tamponade/perforation, device or procedure related death, major vascular access complication/bleeding, myocardial infarction, pericarditis, phrenic nerve paralysis (permanent), pulmonary vein stenosis, stroke/cerebrovascular accident (CVA), thromboembolism, and transient ischemic attack (TIA).
Time Frame Within 7 days post-procedure on Day 0
Hide Outcome Measure Data
Hide Analysis Population Description
Wave I and Wave II (Main Phase): The full analysis set (FAS) included all enrolled Wave I and Wave II (main phase) participants who had insertion of the study catheter (with or without delivery of pulse field ablation [PFA]); Wave II (Roll-in): The Roll-In analysis set (RI AS) included all Wave II (roll-in) participants who were enrolled in the roll-in phase and underwent ablation with the irreversible electroporation (IRE) ablation system.
Arm/Group Title Wave I Wave II: Main Phase Wave II: Roll-In
Hide Arm/Group Description:
Participants with drug refractory, symptomatic pulse field ablation (PAF) who were candidates for catheter ablation, underwent the index procedure and additional neurological, pulmonary vein (PV) and esophageal assessments to obtain data for preliminary estimates of safety and (acute) effectiveness of the irreversible electroporation (IRE) ablation system.
Participants enrolled in Wave II main phase, were treated with the Circular IRE Catheter in conjunction with the IRE Generator.
Participants enrolled in Wave II roll-in, were treated with the Circular IRE Catheter in conjunction with the IRE Generator.
Overall Number of Participants Analyzed 40 186 30
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
2.Primary Outcome
Title Kaplan-Meier Estimates of the Success Rate of Freedom From Documented (Symptomatic and Asymptomatic) Atrial Arrhythmia (Atrial Fibrillation [AF], Atrial Tachycardia [AT], or Atrial Flutter [AFL]) Episodes From Day 91 to Day 365 Post Index Procedure
Hide Description Kaplan-Meier estimates of the success rate of freedom from primary effectiveness failure, that is, documented (symptomatic and asymptomatic) atrial arrhythmia (AF, AT, or AFL) recurrence based on electrocardiographic data (>=30 seconds on arrhythmia monitoring device) from Day 91 to Day 365 post index procedure, was reported. Acute procedural failure defined as failure to confirm entrance block in all PVs except those that are silent and/or cannot be cannulated post-procedure, use of a non-study catheter for PV isolation, or failure to have PFA delivery with the study catheter due to IRE system malfunctions, was also considered a long-term effectiveness failure.
Time Frame From Day 91 up to Day 365 post index procedure on Day 0
Hide Outcome Measure Data
Hide Analysis Population Description
Wave I and Wave II (Main Phase): The FAS included all enrolled Wave I and Wave II (main phase) participants who had insertion of the study catheter (with or without delivery of PFA); Wave II (Roll-in): The RI AS included all Wave II (roll-in) participants who were enrolled in the roll-in phase and underwent ablation with the IRE ablation system.
Arm/Group Title Wave I Wave II: Main Phase Wave II: Roll-In
Hide Arm/Group Description:
Participants with drug refractory, symptomatic pulse field ablation (PAF) who were candidates for catheter ablation, underwent the index procedure and additional neurological, pulmonary vein (PV) and esophageal assessments to obtain data for preliminary estimates of safety and (acute) effectiveness of the irreversible electroporation (IRE) ablation system.
Participants enrolled in Wave II main phase, were treated with the Circular IRE Catheter in conjunction with the IRE Generator.
Participants enrolled in Wave II roll-in, were treated with the Circular IRE Catheter in conjunction with the IRE Generator.
Overall Number of Participants Analyzed 40 186 30
Measure Type: Number
Unit of Measure: Percentage of participants
71.8 75.6 80.0
3.Secondary Outcome
Title Number of Participants Who Achieved Acute Procedural Success
Hide Description Number of participants who achieved acute procedural success were reported. Acute procedural success was defined as confirmation of entrance block in all clinically relevant targeted pulmonary veins (PVs) after adenosine/ isoproterenol challenge.
Time Frame Day 0 (Day of procedure)
Hide Outcome Measure Data
Hide Analysis Population Description
Wave I and Wave II (Main Phase): The FAS included all enrolled Wave I and Wave II (main phase) participants who had insertion of the study catheter (with or without delivery of PFA); Wave II (Roll-in): The RI AS included all Wave II (roll-in) participants who were enrolled in the roll-in phase and underwent ablation with the IRE ablation system.
Arm/Group Title Wave I Wave II: Main Phase Wave II: Roll-In
Hide Arm/Group Description:
Participants with drug refractory, symptomatic pulse field ablation (PAF) who were candidates for catheter ablation, underwent the index procedure and additional neurological, pulmonary vein (PV) and esophageal assessments to obtain data for preliminary estimates of safety and (acute) effectiveness of the irreversible electroporation (IRE) ablation system.
Participants enrolled in Wave II main phase, were treated with the Circular IRE Catheter in conjunction with the IRE Generator.
Participants enrolled in Wave II roll-in, were treated with the Circular IRE Catheter in conjunction with the IRE Generator.
Overall Number of Participants Analyzed 40 186 30
Measure Type: Count of Participants
Unit of Measure: Participants
40
 100.0%
186
 100.0%
30
 100.0%
4.Secondary Outcome
Title Kaplan-Meier Estimates of the Success Rate of Freedom From Documented Symptomatic Re-Occurrence of Atrial Arrhythmia (Atrial Fibrillation [AF], Atrial Tachycardia [AT], or Atrial Flutter [AFL]) Episodes From Day 91 to Day 365 Post Index Procedure
Hide Description Kaplan-Meier estimates of the success rate of freedom from primary effectiveness failure, that is, documented symptomatic re-occurrence of atrial arrhythmia (AF, AT, or AFL) episodes based on electrocardiographic data (>=30 seconds on arrhythmia monitoring device) from Day 91 to Day 365 post index procedure, was reported. Acute procedural failure defined as failure to confirm entrance block in all PVs except those that are silent and/or cannot be cannulated post-procedure, use of a non-study catheter for PV isolation, or failure to have PFA delivery with the study catheter due to IRE system malfunctions, was also considered a long-term effectiveness failure.
Time Frame From Day 91 up to Day 365 post index procedure on Day 0
Hide Outcome Measure Data
Hide Analysis Population Description
Wave I and Wave II (Main Phase): The FAS included all enrolled Wave I and Wave II (main phase) participants who had insertion of the study catheter (with or without delivery of PFA); Wave II (Roll-in): The RI AS included all Wave II (roll-in) participants who were enrolled in the roll-in phase and underwent ablation with the IRE ablation system.
Arm/Group Title Wave I Wave II: Main Phase Wave II: Roll-In
Hide Arm/Group Description:
Participants with drug refractory, symptomatic pulse field ablation (PAF) who were candidates for catheter ablation, underwent the index procedure and additional neurological, pulmonary vein (PV) and esophageal assessments to obtain data for preliminary estimates of safety and (acute) effectiveness of the irreversible electroporation (IRE) ablation system.
Participants enrolled in Wave II main phase, were treated with the Circular IRE Catheter in conjunction with the IRE Generator.
Participants enrolled in Wave II roll-in, were treated with the Circular IRE Catheter in conjunction with the IRE Generator.
Overall Number of Participants Analyzed 40 186 30
Measure Type: Number
Unit of Measure: Percentage of participants
76.9 81.7 80.0
5.Secondary Outcome
Title Change From Baseline in Atrial Fibrillation Effect on Quality of Life (AFEQT) Total Score
Hide Description Change from baseline in AFEQT total score was reported. The AFEQT questionnaire is an atrial fibrillation-specific health-related quality of life (HRQoL) questionnaire designed to assess the impact of atrial fibrillation on participants' HRQoL. The questionnaire includes 20 questions on a 7-point Likert scale. Questions 1-18 evaluate HRQoL and questions 19-20 relate to participants' satisfaction with treatment. Overall or subscale scores range from 0 to 100, where 0 corresponds to complete disability (or responding "extremely" limited, difficult or bothersome to all questions answered), while a score of 100 corresponds to no disability (or responding "not at all" limited, difficult or bothersome to all questions answered). Therefore, a positive change in score corresponds to improvement in QoL. Total score was calculated using AFEQT formula: 100 -([sum of severity for all questions answered - number of questions answered]*100 / total number questions answered*6).
Time Frame Baseline, Months 3, 6, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all enrolled Wave I and Wave II (main phase) participants who had insertion of the study catheter (with or without delivery of PFA). The RI AS included all Wave II (roll-in) participants who were enrolled in the roll-in phase and underwent ablation with the IRE ablation system. Here, 'N' (number of participants analyzed) indicates number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) is defined as participants analyzed for specified timepoints.
Arm/Group Title Wave I Wave II: Main Phase Wave II: Roll-In
Hide Arm/Group Description:
Participants with drug refractory, symptomatic pulse field ablation (PAF) who were candidates for catheter ablation, underwent the index procedure and additional neurological, pulmonary vein (PV) and esophageal assessments to obtain data for preliminary estimates of safety and (acute) effectiveness of the irreversible electroporation (IRE) ablation system.
Participants enrolled in Wave II main phase, were treated with the Circular IRE Catheter in conjunction with the IRE Generator.
Participants enrolled in Wave II roll-in, were treated with the Circular IRE Catheter in conjunction with the IRE Generator.
Overall Number of Participants Analyzed 35 182 24
Mean (Standard Deviation)
Unit of Measure: Units on a score
Month 3 Number Analyzed 35 participants 182 participants 24 participants
27.38  (19.685) 23.02  (22.755) 26.03  (22.693)
Month 6 Number Analyzed 34 participants 182 participants 24 participants
28.21  (16.422) 25.06  (20.793) 24.77  (23.414)
Month 12 Number Analyzed 35 participants 176 participants 24 participants
30.5  (19.897) 26.05  (21.642) 31.17  (19.723)
Time Frame From screening up to 12 months
Adverse Event Reporting Description Wave I and Wave II (Main Phase): The full analysis set (FAS) included all enrolled Wave I and Wave II (main phase) participants who had insertion of the study catheter (with or without delivery of pulse field ablation [PFA]); Wave II (Roll-in): The Roll-In analysis set (RI AS) included all Wave II (roll-in) participants who were enrolled in the roll-in phase and underwent ablation with the irreversible electroporation (IRE) ablation system.
 
Arm/Group Title Wave I Wave II: Main Phase Wave II: Roll-In
Hide Arm/Group Description Participants with drug refractory, symptomatic pulse field ablation (PAF) who were candidates for catheter ablation, underwent the index procedure and additional neurological, pulmonary vein (PV) and esophageal assessments to obtain data for preliminary estimates of safety and (acute) effectiveness of the irreversible electroporation (IRE) ablation system. Participants enrolled in Wave II main phase, were treated with the Circular IRE Catheter in conjunction with the IRE Generator. Participants enrolled in Wave II roll-in, were treated with the Circular IRE Catheter in conjunction with the IRE Generator.
All-Cause Mortality
Wave I Wave II: Main Phase Wave II: Roll-In
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)      0/186 (0.00%)      0/30 (0.00%)    
Hide Serious Adverse Events
Wave I Wave II: Main Phase Wave II: Roll-In
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/40 (7.50%)      9/186 (4.84%)      2/30 (6.67%)    
Cardiac disorders       
Acute coronary syndrome * 1  1/40 (2.50%)  1 0/186 (0.00%)  0 0/30 (0.00%)  0
Coronary artery occlusion * 1  1/40 (2.50%)  1 0/186 (0.00%)  0 0/30 (0.00%)  0
Atrial flutter * 1  0/40 (0.00%)  0 0/186 (0.00%)  0 1/30 (3.33%)  1
Angina pectoris * 1  0/40 (0.00%)  0 1/186 (0.54%)  1 0/30 (0.00%)  0
Ventricular tachycardia * 1  0/40 (0.00%)  0 1/186 (0.54%)  1 0/30 (0.00%)  0
Gastrointestinal disorders       
Inguinal hernia * 1  0/40 (0.00%)  0 1/186 (0.54%)  1 0/30 (0.00%)  0
Infections and infestations       
Respiratory tract infection * 1  0/40 (0.00%)  0 0/186 (0.00%)  0 1/30 (3.33%)  1
Musculoskeletal and connective tissue disorders       
Arthritis * 1  1/40 (2.50%)  1 0/186 (0.00%)  0 0/30 (0.00%)  0
Arthralgia * 1  0/40 (0.00%)  0 1/186 (0.54%)  1 0/30 (0.00%)  0
Intervertebral disc protrusion * 1  0/40 (0.00%)  0 1/186 (0.54%)  1 0/30 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Invasive lobular breast carcinoma * 1  0/40 (0.00%)  0 1/186 (0.54%)  1 0/30 (0.00%)  0
Lung neoplasm malignant * 1  0/40 (0.00%)  0 1/186 (0.54%)  1 0/30 (0.00%)  0
Renal and urinary disorders       
Nephrolithiasis * 1  0/40 (0.00%)  0 0/186 (0.00%)  0 1/30 (3.33%)  1
Haematuria * 1  0/40 (0.00%)  0 1/186 (0.54%)  1 0/30 (0.00%)  0
Urinary retention * 1  0/40 (0.00%)  0 1/186 (0.54%)  1 0/30 (0.00%)  0
1
Term from vocabulary, MedDRA 23.0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Wave I Wave II: Main Phase Wave II: Roll-In
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   30/40 (75.00%)      85/186 (45.70%)      17/30 (56.67%)    
Blood and lymphatic system disorders       
Anaemia * 1  0/40 (0.00%)  0 1/186 (0.54%)  1 0/30 (0.00%)  0
Cardiac disorders       
Atrial flutter * 1  4/40 (10.00%)  5 10/186 (5.38%)  10 0/30 (0.00%)  0
Palpitation * 1  1/40 (2.50%)  1 2/186 (1.08%)  2 0/30 (0.00%)  0
Ventricular tachycardia * 1  1/40 (2.50%)  1 1/186 (0.54%)  1 0/30 (0.00%)  0
Atrial tachycardia * 1  0/40 (0.00%)  0 3/186 (1.61%)  3 1/30 (3.33%)  1
Coronary artery stenosis * 1  0/40 (0.00%)  0 1/186 (0.54%)  1 1/30 (3.33%)  1
Mayocarditis * 1  0/40 (0.00%)  0 0/186 (0.00%)  0 1/30 (3.33%)  1
Pericarditis * 1  0/40 (0.00%)  0 1/186 (0.54%)  1 1/30 (3.33%)  1
Supraventricular tachycardia * 1  0/40 (0.00%)  0 2/186 (1.08%)  2 2/30 (6.67%)  2
Angina pectoris * 1  0/40 (0.00%)  0 1/186 (0.54%)  1 0/30 (0.00%)  0
Atrioventricular block second degree * 1  0/40 (0.00%)  0 1/186 (0.54%)  1 0/30 (0.00%)  0
Bundle branch block left * 1  0/40 (0.00%)  0 1/186 (0.54%)  1 0/30 (0.00%)  0
Chronotropic incompetence * 1  0/40 (0.00%)  0 2/186 (1.08%)  2 0/30 (0.00%)  0
Sinus arrest * 1  0/40 (0.00%)  0 1/186 (0.54%)  1 0/30 (0.00%)  0
Supraventricular extrasystoles * 1  0/40 (0.00%)  0 1/186 (0.54%)  1 0/30 (0.00%)  0
Tachycardia * 1  0/40 (0.00%)  0 2/186 (1.08%)  2 0/30 (0.00%)  0
Congenital, familial and genetic disorders       
Hypertrophic cardiomyopathy * 1  0/40 (0.00%)  0 1/186 (0.54%)  1 0/30 (0.00%)  0
Endocrine disorders       
Hyperthyroidism * 1  0/40 (0.00%)  0 2/186 (1.08%)  2 0/30 (0.00%)  0
Eye disorders       
Cataract * 1  0/40 (0.00%)  0 0/186 (0.00%)  0 1/30 (3.33%)  1
Vision blurred * 1  0/40 (0.00%)  0 0/186 (0.00%)  0 1/30 (3.33%)  1
Gastrointestinal disorders       
Dyspepsia * 1  1/40 (2.50%)  1 0/186 (0.00%)  0 0/30 (0.00%)  0
Erosive oesophagatis * 1  1/40 (2.50%)  1 0/186 (0.00%)  0 0/30 (0.00%)  0
Gastric ulcer * 1  1/40 (2.50%)  1 0/186 (0.00%)  0 0/30 (0.00%)  0
Gastritis erosive * 1  1/40 (2.50%)  1 0/186 (0.00%)  0 0/30 (0.00%)  0
Gastritis haemorrhagic * 1  2/40 (5.00%)  2 0/186 (0.00%)  0 0/30 (0.00%)  0
Gastroesophageal reflux disease * 1  2/40 (5.00%)  2 0/186 (0.00%)  0 0/30 (0.00%)  0
Nausea * 1  2/40 (5.00%)  2 1/186 (0.54%)  1 0/30 (0.00%)  0
Oesophageal mucosa erythema * 1  1/40 (2.50%)  1 0/186 (0.00%)  0 0/30 (0.00%)  0
Abdominal discomfort * 1  0/40 (0.00%)  0 0/186 (0.00%)  0 1/30 (3.33%)  1
Diarrhoea * 1  0/40 (0.00%)  0 0/186 (0.00%)  0 1/30 (3.33%)  1
Abdominal pain upper * 1  0/40 (0.00%)  0 1/186 (0.54%)  1 0/30 (0.00%)  0
Constipation * 1  0/40 (0.00%)  0 1/186 (0.54%)  1 0/30 (0.00%)  0
Flatulence * 1  0/40 (0.00%)  0 1/186 (0.54%)  1 0/30 (0.00%)  0
Gastritis * 1  0/40 (0.00%)  0 1/186 (0.54%)  1 0/30 (0.00%)  0
Large intestine polyp * 1  0/40 (0.00%)  0 2/186 (1.08%)  2 0/30 (0.00%)  0
Tooth impacted * 1  0/40 (0.00%)  0 1/186 (0.54%)  1 0/30 (0.00%)  0
General disorders       
Chest pain * 1  1/40 (2.50%)  1 2/186 (1.08%)  2 1/30 (3.33%)  1
Pyrexia * 1  1/40 (2.50%)  1 0/186 (0.00%)  0 0/30 (0.00%)  0
Chest discomfort * 1  0/40 (0.00%)  0 1/186 (0.54%)  1 0/30 (0.00%)  0
Drug withdrawal syndrome * 1  0/40 (0.00%)  0 1/186 (0.54%)  1 0/30 (0.00%)  0
Fatigue * 1  0/40 (0.00%)  0 3/186 (1.61%)  3 0/30 (0.00%)  0
Influenza like illness * 1  0/40 (0.00%)  0 1/186 (0.54%)  1 0/30 (0.00%)  0
Hepatobiliary disorders       
Cholecystitis * 1  0/40 (0.00%)  0 0/186 (0.00%)  0 1/30 (3.33%)  1
Infections and infestations       
Bronchitis * 1  1/40 (2.50%)  1 0/186 (0.00%)  0 0/30 (0.00%)  0
COVID-19 * 1  4/40 (10.00%)  4 16/186 (8.60%)  16 6/30 (20.00%)  6
Pharyngitis * 1  1/40 (2.50%)  1 0/186 (0.00%)  0 0/30 (0.00%)  0
Asymptomatic COVID-19 * 1  0/40 (0.00%)  0 0/186 (0.00%)  0 1/30 (3.33%)  1
Herpes zoster * 1  0/40 (0.00%)  0 1/186 (0.54%)  1 1/30 (3.33%)  1
Sinusitis * 1  0/40 (0.00%)  0 0/186 (0.00%)  0 1/30 (3.33%)  1
Urinary tract infection * 1  0/40 (0.00%)  0 3/186 (1.61%)  3 1/30 (3.33%)  1
Abdominal infection * 1  0/40 (0.00%)  0 1/186 (0.54%)  1 0/30 (0.00%)  0
Gastroenteritis * 1  0/40 (0.00%)  0 1/186 (0.54%)  1 0/30 (0.00%)  0
Gingivitis * 1  0/40 (0.00%)  0 1/186 (0.54%)  1 0/30 (0.00%)  0
Infection * 1  0/40 (0.00%)  0 1/186 (0.54%)  1 0/30 (0.00%)  0
Influenza * 1  0/40 (0.00%)  0 1/186 (0.54%)  1 0/30 (0.00%)  0
Nasopharyngitis * 1  0/40 (0.00%)  0 1/186 (0.54%)  1 0/30 (0.00%)  0
Pneumonia * 1  0/40 (0.00%)  0 4/186 (2.15%)  4 0/30 (0.00%)  0
Respiratory tract infection * 1  0/40 (0.00%)  0 1/186 (0.54%)  1 0/30 (0.00%)  0
Soft tissue infection * 1  0/40 (0.00%)  0 1/186 (0.54%)  1 0/30 (0.00%)  0
Injury, poisoning and procedural complications       
Endotracheal intubation complication * 1  5/40 (12.50%)  6 0/186 (0.00%)  0 0/30 (0.00%)  0
Vascular pseudoaneurysm * 1  1/40 (2.50%)  1 0/186 (0.00%)  0 0/30 (0.00%)  0
Meniscus injury * 1  0/40 (0.00%)  0 0/186 (0.00%)  0 1/30 (3.33%)  1
Tendon rupture * 1  0/40 (0.00%)  0 0/186 (0.00%)  0 1/30 (3.33%)  1
Ankle Fracture * 1  0/40 (0.00%)  0 1/186 (0.54%)  1 0/30 (0.00%)  0
Avulsion fracture * 1  0/40 (0.00%)  0 1/186 (0.54%)  1 0/30 (0.00%)  0
Epicondylitis * 1  0/40 (0.00%)  0 1/186 (0.54%)  1 0/30 (0.00%)  0
Fall * 1  0/40 (0.00%)  0 1/186 (0.54%)  1 0/30 (0.00%)  0
Hand fracture * 1  0/40 (0.00%)  0 1/186 (0.54%)  1 0/30 (0.00%)  0
Humerus fracture * 1  0/40 (0.00%)  0 1/186 (0.54%)  1 0/30 (0.00%)  0
Ligament sprain * 1  0/40 (0.00%)  0 2/186 (1.08%)  2 0/30 (0.00%)  0
Lip injury * 1  0/40 (0.00%)  0 1/186 (0.54%)  1 0/30 (0.00%)  0
Radius fracture * 1  0/40 (0.00%)  0 1/186 (0.54%)  1 0/30 (0.00%)  0
Spinal compression fracture * 1  0/40 (0.00%)  0 1/186 (0.54%)  1 0/30 (0.00%)  0
Suture related complication * 1  0/40 (0.00%)  0 1/186 (0.54%)  1 0/30 (0.00%)  0
Vascular pseudoaneurysm * 1  0/4 (0.00%)  0 1/186 (0.54%)  1 0/30 (0.00%)  0
Investigations       
Brain natriuretic peptide increased * 1  0/40 (0.00%)  0 0/186 (0.00%)  0 1/30 (3.33%)  1
Blood potassium decreased * 1  0/40 (0.00%)  0 1/186 (0.54%)  1 0/30 (0.00%)  0
Metabolism and nutrition disorders       
Hyperlipidaemia * 1  0/40 (0.00%)  0 1/186 (0.54%)  1 0/30 (0.00%)  0
Hypokalaemia * 1  0/40 (0.00%)  0 1/186 (0.54%)  1 0/30 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Back pain * 1  1/40 (2.50%)  1 0/186 (0.00%)  0 0/30 (0.00%)  0
Pain in extremity * 1  1/40 (2.50%)  1 0/186 (0.00%)  0 0/30 (0.00%)  0
Groin pain * 1  0/40 (0.00%)  0 2/186 (1.08%)  2 1/30 (3.33%)  1
Muscle hypertrophy * 1  0/40 (0.00%)  0 0/186 (0.00%)  0 1/30 (3.33%)  1
Arthralgia * 1  0/40 (0.00%)  0 1/186 (0.54%)  1 0/30 (0.00%)  0
Bone loss * 1  0/40 (0.00%)  0 1/186 (0.54%)  1 0/30 (0.00%)  0
Dupuytren's contracture * 1  0/40 (0.00%)  0 1/186 (0.54%)  1 0/30 (0.00%)  0
Exostosis * 1  0/40 (0.00%)  0 1/186 (0.54%)  1 0/30 (0.00%)  0
Facet joint syndrome * 1  0/40 (0.00%)  0 1/186 (0.54%)  1 0/30 (0.00%)  0
Invertebral disc disorder * 1  0/40 (0.00%)  0 1/186 (0.54%)  1 0/30 (0.00%)  0
Muscle fatigue * 1  0/40 (0.00%)  0 1/186 (0.54%)  1 0/30 (0.00%)  0
Muscle tightness * 1  0/40 (0.00%)  0 1/186 (0.54%)  1 0/30 (0.00%)  0
Pain in extremity * 1  0/40 (0.00%)  0 1/186 (0.54%)  1 0/30 (0.00%)  0
Periarthritis * 1  0/40 (0.00%)  0 1/186 (0.54%)  1 0/30 (0.00%)  0
Rotator cuff syndrome * 1  0/40 (0.00%)  0 1/186 (0.54%)  1 0/30 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Prostate cancer * 1  2/40 (5.00%)  2 0/186 (0.00%)  0 0/30 (0.00%)  0
Apocrine breast carcinoma * 1  0/40 (0.00%)  0 0/186 (0.00%)  0 1/30 (3.33%)  1
Lipoma * 1  0/40 (0.00%)  0 0/186 (0.00%)  0 1/30 (3.33%)  1
Adrenal neoplasm * 1  0/40 (0.00%)  0 1/186 (0.54%)  1 0/30 (0.00%)  0
Breast cancer * 1  0/40 (0.00%)  0 1/186 (0.54%)  1 0/30 (0.00%)  0
Chronic lymphocytic leukaemia * 1  0/40 (0.00%)  0 1/186 (0.54%)  1 0/30 (0.00%)  0
Marrow hyperplasia * 1  0/40 (0.00%)  0 1/186 (0.54%)  1 0/30 (0.00%)  0
Prostatic adenoma * 1  0/40 (0.00%)  0 1/186 (0.54%)  1 0/30 (0.00%)  0
Nervous system disorders       
Cerebral artery embolism * 1  9/40 (22.50%)  10 0/186 (0.00%)  0 0/30 (0.00%)  0
Headache * 1  1/40 (2.50%)  1 2/186 (1.08%)  2 2/30 (6.67%)  2
Presyncope * 1  1/40 (2.50%)  1 0/186 (0.00%)  0 1/30 (3.33%)  1
Dizziness * 1  0/40 (0.00%)  0 1/186 (0.54%)  1 1/30 (3.33%)  1
Migraine * 1  0/40 (0.00%)  0 1/186 (0.54%)  1 0/30 (0.00%)  0
Migraine with aura * 1  0/40 (0.00%)  0 3/186 (1.61%)  3 0/30 (0.00%)  0
Syncope * 1  0/40 (0.00%)  0 2/186 (1.08%)  2 0/30 (0.00%)  0
Psychiatric disorders       
Sleep disorder * 1  0/40 (0.00%)  0 0/186 (0.00%)  0 1/30 (3.33%)  1
Agitation * 1  0/40 (0.00%)  0 1/186 (0.54%)  1 0/30 (0.00%)  0
Depression mood * 1  0/40 (0.00%)  0 1/186 (0.54%)  1 0/30 (0.00%)  0
Renal and urinary disorders       
Haematuria * 1  0/40 (0.00%)  0 1/186 (0.54%)  1 1/30 (3.33%)  1
Urinary retention * 1  0/40 (0.00%)  0 1/186 (0.54%)  1 0/30 (0.00%)  0
Reproductive system and breast disorders       
Genital swelling * 1  0/40 (0.00%)  0 1/186 (0.54%)  1 0/30 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Vasomotor rhinitis * 1  1/40 (2.50%)  1 0/186 (0.00%)  0 0/30 (0.00%)  0
Dyspnoea * 1  0/40 (0.00%)  0 3/186 (1.61%)  3 1/30 (3.33%)  1
Haemoptysis * 1  0/40 (0.00%)  0 1/186 (0.54%)  1 0/30 (0.00%)  0
Hyperventilation * 1  0/40 (0.00%)  0 1/186 (0.54%)  1 0/30 (0.00%)  0
Obstructive airways disorder * 1  0/40 (0.00%)  0 1/186 (0.54%)  1 0/30 (0.00%)  0
Oropharyngeal pain * 1  0/40 (0.00%)  0 1/186 (0.54%)  1 0/30 (0.00%)  0
Pulmonary hypertension * 1  0/40 (0.00%)  0 1/186 (0.54%)  1 0/30 (0.00%)  0
Skin and subcutaneous tissue disorders       
Rash * 1  0/40 (0.00%)  0 1/186 (0.54%)  1 1/30 (3.33%)  1
Vascular disorders       
Arteriosclerosis * 1  1/40 (2.50%)  1 0/186 (0.00%)  0 0/30 (0.00%)  0
Haematoma * 1  4/40 (10.00%)  4 1/186 (0.54%)  1 0/30 (0.00%)  0
Hypertension * 1  1/40 (2.50%)  1 6/186 (3.23%)  7 0/30 (0.00%)  0
Hypotension * 1  1/40 (2.50%)  1 1/186 (0.54%)  1 1/30 (3.33%)  1
1
Term from vocabulary, MedDRA 23.0
*
Indicates events were collected by non-systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Authorship will be determined prior to development of any manuscript. All information concerning the study, investigational medical device, sponsor operations, patent application, manufacturing processes, and basic scientific data supplied by the sponsor to the investigator and not previously published, are considered confidential and remain the sole property of the sponsor.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Associate Director - Medical Affairs
Organization: Biosense Webster, Inc.
Phone: 844-434-4210
EMail: ClinicalTrialDisclosure@its.jnj.com
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Responsible Party: Biosense Webster, Inc.
ClinicalTrials.gov Identifier: NCT04524364    
Other Study ID Numbers: BWI_2019_08
BWI_2019_08 ( Other Identifier: Biosense Webster, Inc. )
First Submitted: August 18, 2020
First Posted: August 24, 2020
Results First Submitted: April 17, 2024
Results First Posted: May 14, 2024
Last Update Posted: May 14, 2024