Trial Outcomes & Findings for A Study For Treatment Of Paroxysmal Atrial Fibrillation (PAF) With The THERMOCOOL SMARTTOUCH SF Catheter and TRUPULSE Generator (NCT NCT05752487)

Last Updated: 2025-07-01

Results Overview

Percentage of participants with PAEs (within 7 days following the ablation procedure) was reported. PAEs included the following adverse events atrio-esophageal fistula, pulmonary vein stenosis, device or procedure related death, (that occurred greater than 7 days and less than or equal to 90 days post-procedure), phrenic nerve paralysis (permanent), cardiac tamponade/perforation, stroke/cerebrovascular accident (CVA), major vascular access complication/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

Target enrollment

149 participants

Primary outcome timeframe

90 days post-procedure on Day 1

Results posted on

2025-07-01

Participant Flow

Participant milestones

Participant milestones
Measure	Pulsed Field (PF) /Radiofrequency (RF) Catheter Ablation Participants with drug refractory, paroxysmal atrial fibrillation (PAF) who were candidates for catheter ablation were enrolled and treated with THERMOCOOL SMARTTOUCH SF (STSF) catheter and TRUPULSE generator to deliver radiofrequency (RF) or pulse field (PF) energy during cardiac ablation procedures .
Overall Study STARTED	149
Overall Study Study Catheter Inserted	140
Overall Study COMPLETED	137
Overall Study NOT COMPLETED	12

Reasons for withdrawal

Reasons for withdrawal
Measure	Pulsed Field (PF) /Radiofrequency (RF) Catheter Ablation Participants with drug refractory, paroxysmal atrial fibrillation (PAF) who were candidates for catheter ablation were enrolled and treated with THERMOCOOL SMARTTOUCH SF (STSF) catheter and TRUPULSE generator to deliver radiofrequency (RF) or pulse field (PF) energy during cardiac ablation procedures .
Overall Study Enrolled, not treated	9
Overall Study Study catheter inserted but did not undergo ablation	1
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pulsed Field (PF) /Radiofrequency (RF) Catheter Ablation n=140 Participants Participants with drug refractory, paroxysmal atrial fibrillation (PAF) who were candidates for catheter ablation were enrolled and treated with THERMOCOOL SMARTTOUCH SF (STSF) catheter and TRUPULSE generator to deliver radiofrequency (RF) or pulse field (PF) energy during cardiac ablation procedures .
Age, Continuous	61.6 Years STANDARD_DEVIATION 7.79 • n=140 Participants
Sex: Female, Male Female	60 Participants n=140 Participants
Sex: Female, Male Male	80 Participants n=140 Participants

PRIMARY outcome

Timeframe: 90 days post-procedure on Day 1

Population: Modified intention-to-treat (mITT) analysis set included all enrolled participants who met eligibility criteria and had insertion of the study catheter. Here, 'N' (number of participants analyzed) refers to participants who were evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Pulsed Field (PF) /Radiofrequency (RF) Catheter Ablation n=137 Participants Participants with drug refractory, paroxysmal atrial fibrillation (PAF) who were candidates for catheter ablation were enrolled and treated with THERMOCOOL SMARTTOUCH SF (STSF) catheter and TRUPULSE generator to deliver radiofrequency (RF) or pulse field (PF) energy during cardiac ablation procedures .
Percentage of Participants With Primary Adverse Events (PAEs) Atrio-esophageal Fistula	0.0 percentage of participants
Percentage of Participants With Primary Adverse Events (PAEs) Phrenic Nerve Paralysis (permanent)	0.0 percentage of participants
Percentage of Participants With Primary Adverse Events (PAEs) Pulmonary Vein Stenosis	1.5 percentage of participants
Percentage of Participants With Primary Adverse Events (PAEs) Cardiac Tamponade/perforation	1.5 percentage of participants
Percentage of Participants With Primary Adverse Events (PAEs) Stroke/Cerebrovascular Accident (CVA)	0.7 percentage of participants
Percentage of Participants With Primary Adverse Events (PAEs) Transient Ischemic Attack (TIA)	0.0 percentage of participants
Percentage of Participants With Primary Adverse Events (PAEs) Major Vascular Access Complication / Bleeding	0.0 percentage of participants
Percentage of Participants With Primary Adverse Events (PAEs) Thromboembolism	0.0 percentage of participants
Percentage of Participants With Primary Adverse Events (PAEs) Myocardial Infarction	0.0 percentage of participants
Percentage of Participants With Primary Adverse Events (PAEs) Pericarditis	0.7 percentage of participants
Percentage of Participants With Primary Adverse Events (PAEs) Heart Block	0.0 percentage of participants
Percentage of Participants With Primary Adverse Events (PAEs) Pulmonary Edema (Respiratory Insufficiency)	0.0 percentage of participants
Percentage of Participants With Primary Adverse Events (PAEs) Vagal Nerve injury/Gastroparesis	0.0 percentage of participants
Percentage of Participants With Primary Adverse Events (PAEs) Death (Device or procedure related)	0.0 percentage of participants

PRIMARY outcome

Timeframe: Immediately post-procedure on Day 1

Population: The per protocol analysis set included enrolled eligible participants who had undergone ablation using PF and/or RF energy via the investigational ablation system per clinical investigational plan (CIP), were treated for the study-related arrythmia, and without major CIP deviation that effected the scientific integrity of the safety and effectiveness.

Percentage of participants with acute procedural success were reported. Procedural success was defined as electrical isolation of clinically relevant targeted pulmonary veins (PVs) (confirmed by entrance block) after adenosine/isoproterenol challenge at the end of the index ablation procedure.

Outcome measures

Outcome measures
Measure	Pulsed Field (PF) /Radiofrequency (RF) Catheter Ablation n=137 Participants Participants with drug refractory, paroxysmal atrial fibrillation (PAF) who were candidates for catheter ablation were enrolled and treated with THERMOCOOL SMARTTOUCH SF (STSF) catheter and TRUPULSE generator to deliver radiofrequency (RF) or pulse field (PF) energy during cardiac ablation procedures .
Percentage of Participants With Acute Procedural Success	100 Percentage of participants

SECONDARY outcome

Timeframe: Day 91 to Day 365

Percentage of participants with freedom from documented (symptomatic and asymptomatic) atrial arrhythmia episodes including atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL; unknown origin) episodes based on electrocardiographic data (greater than equal to \[\>=\]30 seconds on arrhythmia monitoring device) were reported. Participants with an AF/AT/AFL (of unknown origin) episode that is \>=30 seconds on arrhythmia monitoring device during the evaluation period were considered failures of this long-term effectiveness outcome measure. Acute procedural failure (that is, failure to achieve entrance block with the study device in any of the targeted pulmonary vein \[PVs\]) were also deemed a failure of this outcome measure. AFL of unknown origin was defined as all AFL except those cavotricuspid isthmus (CTI) dependent AFL as confirmed by 12-lead electrocardiogram (ECG) or entrainment maneuvers in an electrophysiology (EP) study.

Outcome measures

Outcome measures
Measure	Pulsed Field (PF) /Radiofrequency (RF) Catheter Ablation n=134 Participants Participants with drug refractory, paroxysmal atrial fibrillation (PAF) who were candidates for catheter ablation were enrolled and treated with THERMOCOOL SMARTTOUCH SF (STSF) catheter and TRUPULSE generator to deliver radiofrequency (RF) or pulse field (PF) energy during cardiac ablation procedures .
Percentage of Participants With Freedom From Documented (Symptomatic and Asymptomatic) Atrial Arrhythmia	71.6 Percentage of participants

Adverse Events

Pulsed Field (PF) /Radiofrequency (RF) Catheter Ablation

Serious events: 23 serious events

Other events: 90 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Pulsed Field (PF) /Radiofrequency (RF) Catheter Ablation n=149 participants at risk Participants with drug refractory, paroxysmal atrial fibrillation (PAF) who were candidates for catheter ablation were enrolled and treated with THERMOCOOL SMARTTOUCH SF (STSF) catheter and TRUPULSE generator to deliver radiofrequency (RF) or pulse field (PF) energy during cardiac ablation procedures .
Cardiac disorders Atrial flutter	1.3% 2/149 • Number of events 2 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Cardiac disorders Atrial tachycardia	1.3% 2/149 • Number of events 2 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Cardiac disorders Cardiac tamponade	1.3% 2/149 • Number of events 2 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Infections and infestations Diverticulitis	1.3% 2/149 • Number of events 2 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Infections and infestations Pneumonia	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Infections and infestations Postoperative wound infection	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Injury, poisoning and procedural complications Radius fracture	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Injury, poisoning and procedural complications Rib fracture	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Musculoskeletal and connective tissue disorders Arthralgia	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Musculoskeletal and connective tissue disorders Cervical spinal stenosis	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Nervous system disorders Hemianaesthesia	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Nervous system disorders Migraine with aura	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Immune system disorders Anaphylactic shock	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Respiratory, thoracic and mediastinal disorders Pulmonary vein stenosis	1.3% 2/149 • Number of events 2 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Vascular disorders Hypotension	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Cardiac disorders Supraventricular tachycardia	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Nervous system disorders Carpal tunnel syndrome	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Nervous system disorders Radiculopathy	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
General disorders Chest pain	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Gastrointestinal disorders Large intestine polyp	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.

Other adverse events

Other adverse events
Measure	Pulsed Field (PF) /Radiofrequency (RF) Catheter Ablation n=149 participants at risk Participants with drug refractory, paroxysmal atrial fibrillation (PAF) who were candidates for catheter ablation were enrolled and treated with THERMOCOOL SMARTTOUCH SF (STSF) catheter and TRUPULSE generator to deliver radiofrequency (RF) or pulse field (PF) energy during cardiac ablation procedures .
Cardiac disorders Atrial tachycardia	3.4% 5/149 • Number of events 6 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Cardiac disorders Palpitations	2.7% 4/149 • Number of events 4 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Cardiac disorders Bradycardia	2.0% 3/149 • Number of events 4 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Cardiac disorders Sinus tachycardia	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Cardiac disorders Cardiac failure	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Cardiac disorders Chronotropic incompetence	1.3% 2/149 • Number of events 2 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Cardiac disorders Pericarditis	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Cardiac disorders Sinus bradycardia	1.3% 2/149 • Number of events 2 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Nervous system disorders Headache	2.7% 4/149 • Number of events 4 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Nervous system disorders Encephalomalacia	1.3% 2/149 • Number of events 2 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Nervous system disorders Presyncope	1.3% 2/149 • Number of events 2 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Nervous system disorders Syncope	0.67% 1/149 • Number of events 3 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Nervous system disorders Amnesia	0.67% 1/149 • Number of events 2 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Nervous system disorders Aura	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Nervous system disorders Central nervous system lesion	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Nervous system disorders Cerebrovascular accident	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Nervous system disorders Hypoaesthesia	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Nervous system disorders Lacunar infarction	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Nervous system disorders Ophthalmic migraine	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Nervous system disorders Radiculopathy	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
General disorders Fatigue	3.4% 5/149 • Number of events 5 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
General disorders Chest pain	2.7% 4/149 • Number of events 4 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
General disorders Swelling	1.3% 2/149 • Number of events 2 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
General disorders Exercise tolerance decreased	1.3% 2/149 • Number of events 2 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
General disorders Medical device site reaction	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
General disorders Non-cardiac chest pain	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
General disorders Oedema	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
General disorders Oedema peripheral	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
General disorders Pyrexia	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Vascular disorders Hypertension	4.7% 7/149 • Number of events 7 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Vascular disorders Haemorrhage	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Vascular disorders Haematoma	1.3% 2/149 • Number of events 2 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Vascular disorders Hypotension	2.0% 3/149 • Number of events 3 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Infections and infestations COVID-19	4.0% 6/149 • Number of events 6 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Infections and infestations Bronchitis	1.3% 2/149 • Number of events 2 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Infections and infestations Candida infection	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Infections and infestations Helicobacter infection	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Infections and infestations Influenza	2.0% 3/149 • Number of events 3 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Infections and infestations Nasopharyngitis	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Infections and infestations Pharyngitis	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Infections and infestations Pneumonia	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Infections and infestations Upper respiratory tract infection	2.0% 3/149 • Number of events 3 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Musculoskeletal and connective tissue disorders Back pain	3.4% 5/149 • Number of events 5 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Musculoskeletal and connective tissue disorders Pain in extremity	1.3% 2/149 • Number of events 2 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Musculoskeletal and connective tissue disorders Joint effusion	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Musculoskeletal and connective tissue disorders Joint swelling	1.3% 2/149 • Number of events 2 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Musculoskeletal and connective tissue disorders Osteoarthritis	1.3% 2/149 • Number of events 3 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Gastrointestinal disorders Abdominal discomfort	1.3% 2/149 • Number of events 2 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Gastrointestinal disorders Abdominal pain lower	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Gastrointestinal disorders Colitis ulcerative	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Gastrointestinal disorders Dental caries	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Gastrointestinal disorders Enterocolitis	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Gastrointestinal disorders Gastritis erosive	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Gastrointestinal disorders Gingival bleeding	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Gastrointestinal disorders Nausea	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	2.0% 3/149 • Number of events 3 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.3% 2/149 • Number of events 2 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Respiratory, thoracic and mediastinal disorders Laryngospasm	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Respiratory, thoracic and mediastinal disorders Pulmonary vein stenosis	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Injury, poisoning and procedural complications Vascular pseudoaneurysm	1.3% 2/149 • Number of events 2 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Cardiac disorders Atrial flutter	10.7% 16/149 • Number of events 16 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Injury, poisoning and procedural complications Contusion	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Injury, poisoning and procedural complications Joint injury	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Injury, poisoning and procedural complications Laryngeal injury	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Injury, poisoning and procedural complications Ligament injury	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Injury, poisoning and procedural complications Pharyngeal injury	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Injury, poisoning and procedural complications Spinal fracture	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Ear and labyrinth disorders Vertigo	2.0% 3/149 • Number of events 3 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Follicular lymphoma	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin cancer	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Skin and subcutaneous tissue disorders Dermatitis contact	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Skin and subcutaneous tissue disorders Skin lesion	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Endocrine disorders Hyperthyroidism	2.0% 3/149 • Number of events 3 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Investigations Heart rate increased	1.3% 2/149 • Number of events 2 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Renal and urinary disorders Haematuria	1.3% 2/149 • Number of events 2 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Renal and urinary disorders Urinary retention	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Eye disorders Visual impairment	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Hepatobiliary disorders Cholelithiasis	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Immune system disorders Hypersensitivity	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Psychiatric disorders Stress	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Vascular disorders Peripheral artery stenosis	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Eye disorders Amaurosis fugax	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Cardiac disorders Coronary artery stenosis	1.3% 2/149 • Number of events 2 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Cardiac disorders Coronary artery disease	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Cardiac disorders Extrasystoles	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Cardiac disorders Supraventricular extrasystoles	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
General disorders Puncture site haemorrhage	2.7% 4/149 • Number of events 4 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
General disorders Puncture site pain	2.0% 3/149 • Number of events 3 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Infections and infestations Cystitis	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Infections and infestations Ear infection	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Infections and infestations Nasal vestibulitis	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Infections and infestations Viral infection	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Infections and infestations Urinary tract infection	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Infections and infestations Vulvovaginal mycotic infection	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Nervous system disorders Ageusia	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Nervous system disorders Anosmia	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Nervous system disorders Balance disorder	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Nervous system disorders Cognitive disorder	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Nervous system disorders Transient ischaemic attack	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Gastrointestinal disorders Haemorrhoids	1.3% 2/149 • Number of events 2 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Gastrointestinal disorders Constipation	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Gastrointestinal disorders Diarrhoea	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Gastrointestinal disorders Diverticulum	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Gastrointestinal disorders Rectal lesion	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Musculoskeletal and connective tissue disorders Arthralgia	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Musculoskeletal and connective tissue disorders Myalgia	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	2.7% 4/149 • Number of events 4 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Respiratory, thoracic and mediastinal disorders Lung consolidation	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Injury, poisoning and procedural complications Bone contusion	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Injury, poisoning and procedural complications Lower limb fracture	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Injury, poisoning and procedural complications Meniscus injury	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Eye disorders Cataract	1.3% 2/149 • Number of events 2 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Eye disorders Glaucoma	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Investigations Blood pressure increased	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Investigations Gamma-glutamyltransferase increased	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Investigations Spirometry	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Psychiatric disorders Anxiety	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Psychiatric disorders Drug abuse	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Reproductive system and breast disorders Atrophic vulvovaginitis	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Reproductive system and breast disorders Cystocele	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Hepatobiliary disorders Hepatic steatosis	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Congenital, familial and genetic disorders Hereditary haemochromatosis	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Metabolism and nutrition disorders Hypercholesterolaemia	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.67% 1/149 • Number of events 1 • From screening (Day -60) up to 12 months Safety data was analyzed based on all enrolled participants.

Additional Information

Director Medical Affairs

Biosense Webster, Inc.

Phone: 844-434-4210

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place