Study: NCT04133168

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 326 at risk

Adverse event: Chest pain-other
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 326 at risk

Adverse event: Sinus bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 326 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 326 at risk

Adverse event: Musculoskeletal
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 326 at risk

Adverse event: Peripheral vascular disorder
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 326 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 326 at risk

Adverse event: Hematological
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 326 at risk

Adverse event: Physical Trauma
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 326 at risk

Adverse event: 1st Degree AV block
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 326 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 326 at risk

Adverse event: Atypical (Type II) Atrial Flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 326 at risk

Adverse event: Hypertensive/ Hypertensive crisis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 326 at risk

Adverse event: Palpitations
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 326 at risk

Adverse event: Syncope
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 326 at risk

Adverse event: Ventricular Tachycardiac (VT)/ Monomorphic VT
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 326 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 326 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 326 at risk

Adverse event: Genitourinary
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 326 at risk

Adverse event: Neurological
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 326 at risk

Adverse event: Presyncope
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 326 at risk

Adverse event: Procedure related Pulmonary (including cough, hemoptysis)
Serious: no
Organ System: Surgical and medical procedures
Frequency: 5 affected / 326 at risk

Adverse event: Atrial (Type I) Flutter
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 326 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 326 at risk

Adverse event: Atrial flutter
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 326 at risk

Adverse event: Chest pain- other
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 326 at risk

Adverse event: Conduction pathway injury
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 326 at risk

Adverse event: Coronary artery disease
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 326 at risk

Adverse event: Dizziness
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 326 at risk

Adverse event: Hypertension/ Hypertensive crisis
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 326 at risk

Adverse event: Hypotension/ Orthostatic hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 326 at risk

Adverse event: Multiple symptoms
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 326 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 326 at risk

Adverse event: Sinus bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 326 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 326 at risk

Adverse event: Ventricular Tachycardia (VT)/ Monomorphic VT
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 326 at risk

Adverse event: Fever and/or virus
Serious: no
Organ System: General disorders
Frequency: 1 affected / 326 at risk

Adverse event: Head, Eyes, Ears, Nose, Throat (HEENT)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 326 at risk

Adverse event: Hematological
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 326 at risk

Adverse event: Neurological
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 326 at risk

Adverse event: Physical Trauma
Serious: no
Organ System: General disorders
Frequency: 1 affected / 326 at risk

Adverse event: Pulmonary
Serious: no
Organ System: General disorders
Frequency: 1 affected / 326 at risk

Adverse event: Renal
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 326 at risk

Adverse event: Procedure related Anesthesia/ sedation
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 326 at risk

Adverse event: Ablation induced Arrhythmia
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 326 at risk

Adverse event: Angina/ chest pain
Serious: no
Organ System: Surgical and medical procedures
Frequency: 5 affected / 326 at risk

Adverse event: Atrial Flutter (not specified)
Serious: no
Organ System: Surgical and medical procedures
Frequency: 6 affected / 326 at risk

Adverse event: Bleeding related to anticogulation
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 326 at risk

Adverse event: Oedema
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 326 at risk

Adverse event: Embolism - air
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 326 at risk

Adverse event: Oesophagitis
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 326 at risk

Adverse event: Gasteroparesis
Serious: no
Organ System: Surgical and medical procedures
Frequency: 5 affected / 326 at risk

Adverse event: Haematoma
Serious: no
Organ System: Surgical and medical procedures
Frequency: 13 affected / 326 at risk

Adverse event: Myocardial infarction
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 326 at risk

Adverse event: Myocardial Perforation with tamponade
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 326 at risk

Adverse event: Oozing/ bleeding
Serious: no
Organ System: Surgical and medical procedures
Frequency: 7 affected / 326 at risk

Adverse event: Pain (non-cardiovascular)
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 326 at risk

Adverse event: Pericarditis
Serious: no
Organ System: Surgical and medical procedures
Frequency: 13 affected / 326 at risk

Adverse event: Phrenic Nerve Injury temporary
Serious: no
Organ System: Surgical and medical procedures
Frequency: 10 affected / 326 at risk

Adverse event: Pleurisy
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 326 at risk

Adverse event: Post procedure infection/ Sepsis
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 326 at risk

Adverse event: Post procedure wound discomfort
Serious: no
Organ System: Surgical and medical procedures
Frequency: 5 affected / 326 at risk

Adverse event: Procedure related allergic reactions/ adverse drug reaction
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 326 at risk

Adverse event: Procedure related anesthesia/ sedation
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 326 at risk

Adverse event: Procedure related gastrointestinal
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 326 at risk

Adverse event: Procedure related hypertension
Serious: no
Organ System: Surgical and medical procedures
Frequency: 3 affected / 326 at risk

Adverse event: Procedure related Neurological (non-TIA, non-stroke, dysphagia, speech disturbance/ dysarthria)
Serious: no
Organ System: Surgical and medical procedures
Frequency: 4 affected / 326 at risk

Adverse event: Pulmonary oedema
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 326 at risk

Adverse event: Right atrial (type 1) atrial flutter
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 326 at risk

Adverse event: Chest pain-other
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 60 at risk

Adverse event: Fever and/or virus
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 60 at risk

Adverse event: Musculoskeletal
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 60 at risk

Adverse event: Atrial Tachycardia/ Other SVT (e.g. AVRT, AVNRT, EAT)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 60 at risk

Adverse event: Multiple Symptoms
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Peripheral vascular disorder
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 60 at risk

Adverse event: Abnormal lab values
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 60 at risk

Adverse event: Hematological
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 60 at risk

Adverse event: Physical Trauma
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pulmonary
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 60 at risk

Adverse event: Dizziness
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 60 at risk

Adverse event: Hypertension/ Hypertensive crisis
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 60 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 60 at risk

Adverse event: Fever and/or virus
Serious: no
Organ System: General disorders
Frequency: 2 affected / 60 at risk

Adverse event: Procedure related Anesthesia/ sedation
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 60 at risk

Adverse event: Atrial tachycardia/ Other SVT (e.g AVRT, AVNRT, EAT)
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 60 at risk

Adverse event: Localised infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 60 at risk

Adverse event: Psychological
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Ablation induced Arrhythmia
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 60 at risk

Adverse event: Gasteroparesis
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 60 at risk

Adverse event: Pericarditis
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 60 at risk

Adverse event: Phrenic Nerve Injury temporary
Serious: no
Organ System: Surgical and medical procedures
Frequency: 3 affected / 60 at risk

Adverse event: Post procedure wound discomfort
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 60 at risk

Adverse event: Procedure related anesthesia/ sedation
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 60 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 60 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 50 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 50 at risk

Adverse event: Sinus bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 50 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Integumentary
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 50 at risk

Adverse event: Chest pain- other
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 50 at risk

Adverse event: Dizziness
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 50 at risk

Adverse event: Fever and/or virus
Serious: no
Organ System: General disorders
Frequency: 2 affected / 50 at risk

Adverse event: Head, Eyes, Ears, Nose, Throat (HEENT)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 50 at risk

Adverse event: Premature atrial contractions (PAC)
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 50 at risk

Adverse event: Musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 50 at risk