Study: NCT04612244

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 305 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 305 at risk

Adverse event: Atrial Flutter-Not Specified
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 305 at risk

Adverse event: Atypical (Type II) Atrial Flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 305 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 305 at risk

Adverse event: Chest Pain Other
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 305 at risk

Adverse event: Conduction Disturbances/ Arrhythmia-Other
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 305 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 305 at risk

Adverse event: Myocardial Perforation with Tamponade
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 305 at risk

Adverse event: Symptomatic Pericardial Effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 305 at risk

Adverse event: Cardiac ventricular thrombosis
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 305 at risk

Adverse event: HEENT
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 305 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 305 at risk

Adverse event: EP/ ablation Other- Multi Organ Failure
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 305 at risk

Adverse event: Pericarditis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 305 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 305 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 305 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 305 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 305 at risk

Adverse event: Systemic infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 305 at risk

Adverse event: Access Site Complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 305 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 305 at risk

Adverse event: Musculoskeletal
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 305 at risk

Adverse event: Oozing/Bleeding
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 305 at risk

Adverse event: Physical Trauma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 305 at risk

Adverse event: Vascular pseudoaneurysm
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 305 at risk

Adverse event: Procedure Related Hypertension
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 305 at risk

Adverse event: Abnormal Lab Values
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 305 at risk

Adverse event: Musculoskeletal
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 305 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 305 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 305 at risk

Adverse event: Procedure Related Genitourinary
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 305 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 305 at risk

Adverse event: Fistula (Arterial/Venous)
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 305 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 12 affected / 305 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 305 at risk

Adverse event: Coronavirus infection
Serious: no
Organ System: Infections and infestations
Frequency: 30 affected / 305 at risk

Adverse event: Post Procedure Wound Discomfort
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 19 affected / 305 at risk

Adverse event: Musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 15 affected / 305 at risk

Adverse event: Patient Condition-Non Cardiovascular-Other
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 302 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 302 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 302 at risk

Adverse event: Atrial Flutter-Not Specified
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 302 at risk

Adverse event: Atrial Tachycardia Other SVT
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 302 at risk

Adverse event: Atypical (Type II) Atrial Flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 302 at risk

Adverse event: Cardiac Tamponade- Unrelated to Procedure/Device
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 302 at risk

Adverse event: Left Atrial (Type II, Atypical) Atrial Flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 302 at risk

Adverse event: Myocarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 302 at risk

Adverse event: SinuasBradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 302 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 302 at risk

Adverse event: Hemorrhage Unrelated to Procedure
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 302 at risk

Adverse event: Pain Cardiovascular (Non-Ischemic)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 302 at risk

Adverse event: Hemorrhage Unelated to Procedure
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 302 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 302 at risk

Adverse event: Coronavirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 302 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 302 at risk

Adverse event: Localised infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 302 at risk

Adverse event: Systemic infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 302 at risk

Adverse event: Physical Trauma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 302 at risk

Adverse event: Vascular pseudoaneurysm
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 302 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 302 at risk

Adverse event: Whole Body Other
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 302 at risk

Adverse event: Musculoskeletal
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 302 at risk

Adverse event: Cerebral Vascular Accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 302 at risk

Adverse event: Neurological
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 302 at risk

Adverse event: Syncope
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 302 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 302 at risk

Adverse event: Psychological
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 302 at risk

Adverse event: Procedure Related Genitourinary
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 302 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 302 at risk

Adverse event: Integumentary
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 302 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 302 at risk

Adverse event: Death
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 302 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 22 affected / 302 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 302 at risk

Adverse event: Coronavirus infection
Serious: no
Organ System: Infections and infestations
Frequency: 37 affected / 302 at risk

Adverse event: Post Procedure Wound Discomfort
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 8 affected / 302 at risk

Adverse event: Musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 21 affected / 302 at risk