Study: NCT04580914

Adverse event: Atrial flutter, not specified
Serious: yes
Organ System: Surgical and medical procedures
Notes: Ablation Related
Frequency: 1 affected / 299 at risk

Adverse event: Fistula (Arterial/Venous)
Serious: yes
Organ System: Surgical and medical procedures
Notes: Ablation Related
Frequency: 1 affected / 299 at risk

Adverse event: Haemodynamic instability
Serious: yes
Organ System: Surgical and medical procedures
Notes: Ablation Related
Frequency: 1 affected / 299 at risk

Adverse event: Myocardial Perforation with Tamponade
Serious: yes
Organ System: Surgical and medical procedures
Notes: Ablation Related
Frequency: 1 affected / 299 at risk

Adverse event: Oozing/Bleeding
Serious: yes
Organ System: Surgical and medical procedures
Notes: Ablation Related
Frequency: 1 affected / 299 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Surgical and medical procedures
Notes: Ablation Related
Frequency: 3 affected / 299 at risk

Adverse event: Pericarditis
Serious: yes
Organ System: Surgical and medical procedures
Notes: Ablation Related
Frequency: 6 affected / 299 at risk

Adverse event: Post procedure infection/sepsis
Serious: yes
Organ System: Surgical and medical procedures
Notes: Ablation Related
Frequency: 1 affected / 299 at risk

Adverse event: Procedure related Abnormal labs
Serious: yes
Organ System: Surgical and medical procedures
Notes: Ablation Related
Frequency: 1 affected / 299 at risk

Adverse event: Procedure related Allergic reactions/Adverse drug reaction
Serious: yes
Organ System: Surgical and medical procedures
Notes: Ablation Related
Frequency: 1 affected / 299 at risk

Adverse event: Procedure related anesthesia/sedation
Serious: yes
Organ System: Surgical and medical procedures
Notes: Ablation Related
Frequency: 2 affected / 299 at risk

Adverse event: Procedure related Gastrointestinal
Serious: yes
Organ System: Surgical and medical procedures
Notes: Ablation Related
Frequency: 2 affected / 299 at risk

Adverse event: Procedure related Genitourinary/Renal
Serious: yes
Organ System: Surgical and medical procedures
Notes: Ablation Related
Frequency: 1 affected / 299 at risk

Adverse event: Vascular pseudoaneurysm
Serious: yes
Organ System: Surgical and medical procedures
Notes: Ablation Related
Frequency: 1 affected / 299 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Surgical and medical procedures
Notes: Ablation Related
Frequency: 1 affected / 299 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Surgical and medical procedures
Notes: Ablation Related
Frequency: 2 affected / 299 at risk

Adverse event: Right atrial (Type I) atrial flutter
Serious: yes
Organ System: Surgical and medical procedures
Notes: Ablation Related
Frequency: 1 affected / 299 at risk

Adverse event: Sinus bradycardia
Serious: yes
Organ System: Surgical and medical procedures
Notes: Ablation Related
Frequency: 1 affected / 299 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Surgical and medical procedures
Notes: Ablation Related
Frequency: 1 affected / 299 at risk

Adverse event: Atrial Fibrillation (AF)
Serious: yes
Organ System: Cardiac disorders
Notes: Cardiovascular
Frequency: 4 affected / 299 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Notes: Cardiovascular
Frequency: 2 affected / 299 at risk

Adverse event: Atrial tachycardia/Other SVT (e.g. AVRT, AVNRT, EAT)
Serious: yes
Organ System: Cardiac disorders
Notes: Cardiovascular
Frequency: 1 affected / 299 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Notes: Cardiovascular
Frequency: 2 affected / 299 at risk

Adverse event: Dyspnea - Heart Failure
Serious: yes
Organ System: Cardiac disorders
Notes: Cardiovascular
Frequency: 1 affected / 299 at risk

Adverse event: Heart Failure symptoms - Unspecified
Serious: yes
Organ System: Cardiac disorders
Notes: Cardiovascular
Frequency: 1 affected / 299 at risk

Adverse event: Infection - Unrelated procedure/device
Serious: yes
Organ System: Cardiac disorders
Notes: Cardiovascular
Frequency: 1 affected / 299 at risk

Adverse event: Multiple Symptoms
Serious: yes
Organ System: Cardiac disorders
Notes: Cardiovascular
Frequency: 1 affected / 299 at risk

Adverse event: Ventricular Tachycardia (VT)/Monomorphic VT
Serious: yes
Organ System: Cardiac disorders
Notes: Cardiovascular
Frequency: 1 affected / 299 at risk

Adverse event: Abnormal laboratory values
Serious: yes
Organ System: General disorders
Notes: Non-Cardiovascular
Frequency: 2 affected / 299 at risk

Adverse event: Adverse reaction - Medication
Serious: yes
Organ System: General disorders
Notes: Non-Cardiovascular
Frequency: 1 affected / 299 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: General disorders
Notes: Non-Cardiovascular
Frequency: 2 affected / 299 at risk

Adverse event: Fever and/or virus
Serious: yes
Organ System: General disorders
Notes: Non-Cardiovascular
Frequency: 2 affected / 299 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: General disorders
Notes: Non-Cardiovascular
Frequency: 3 affected / 299 at risk

Adverse event: Head, Eyes, Ears, Nose, Throat (HEENT)
Serious: yes
Organ System: General disorders
Notes: Non-Cardiovascular
Frequency: 1 affected / 299 at risk

Adverse event: Hematological
Serious: yes
Organ System: General disorders
Notes: Non-Cardiovascular
Frequency: 2 affected / 299 at risk

Adverse event: Musculoskeletal
Serious: yes
Organ System: General disorders
Notes: Non-Cardiovascular
Frequency: 4 affected / 299 at risk

Adverse event: Neurological
Serious: yes
Organ System: General disorders
Notes: Non-Cardiovascular
Frequency: 2 affected / 299 at risk

Adverse event: Physical Trauma
Serious: yes
Organ System: General disorders
Notes: Non-Cardiovascular
Frequency: 1 affected / 299 at risk

Adverse event: Psychological
Serious: yes
Organ System: General disorders
Notes: Non-Cardiovascular
Frequency: 1 affected / 299 at risk

Adverse event: Pulmonary
Serious: yes
Organ System: General disorders
Notes: Non-Cardiovascular
Frequency: 4 affected / 299 at risk

Adverse event: Angina/Chest pain
Serious: no
Organ System: Surgical and medical procedures
Notes: Ablation Related
Frequency: 1 affected / 299 at risk

Adverse event: Atrial Fibrillation (AF)
Serious: no
Organ System: Surgical and medical procedures
Notes: Ablation Relate
Frequency: 2 affected / 299 at risk

Adverse event: Atrial flutter, not specified
Serious: no
Organ System: Surgical and medical procedures
Notes: Ablation Related
Frequency: 1 affected / 299 at risk

Adverse event: Bleeding related to anticoagulation
Serious: no
Organ System: Surgical and medical procedures
Notes: Ablation Related
Frequency: 1 affected / 299 at risk

Adverse event: Oedema
Serious: no
Organ System: Surgical and medical procedures
Notes: Ablation Related
Frequency: 1 affected / 299 at risk

Adverse event: Haematoma
Serious: no
Organ System: Surgical and medical procedures
Notes: Ablation Related
Frequency: 2 affected / 299 at risk

Adverse event: Nerve injury
Serious: no
Organ System: Surgical and medical procedures
Notes: Ablation Related
Frequency: 1 affected / 299 at risk

Adverse event: Oozing/Bleeding
Serious: no
Organ System: Surgical and medical procedures
Notes: Ablation Related
Frequency: 3 affected / 299 at risk

Adverse event: Pain (Non-cardiovascular)
Serious: no
Organ System: Surgical and medical procedures
Notes: Ablation Related
Frequency: 3 affected / 299 at risk

Adverse event: Pain cardiovascular (Non-ischemic)
Serious: no
Organ System: Surgical and medical procedures
Notes: Ablation Related
Frequency: 3 affected / 299 at risk

Adverse event: Pericardial effusion
Serious: no
Organ System: Surgical and medical procedures
Notes: Ablation Related
Frequency: 2 affected / 299 at risk

Adverse event: Pericarditis
Serious: no
Organ System: Surgical and medical procedures
Notes: Ablation Related
Frequency: 16 affected / 299 at risk

Adverse event: Pleurisy
Serious: no
Organ System: Surgical and medical procedures
Notes: Ablation Related
Frequency: 1 affected / 299 at risk

Adverse event: Post procedure infection/sepsis
Serious: no
Organ System: Surgical and medical procedures
Notes: Ablation Related
Frequency: 3 affected / 299 at risk

Adverse event: Post procedure wound discomfort
Serious: no
Organ System: Surgical and medical procedures
Notes: Ablation Related
Frequency: 1 affected / 299 at risk

Adverse event: Procedure related Allergic reactions/Adverse drug reaction
Serious: no
Organ System: Surgical and medical procedures
Notes: Ablation Related
Frequency: 2 affected / 299 at risk

Adverse event: Procedure related Anesthesia/Sedation
Serious: no
Organ System: Surgical and medical procedures
Notes: Ablation Related
Frequency: 3 affected / 299 at risk

Adverse event: Procedure related Gastrointestinal
Serious: no
Organ System: Surgical and medical procedures
Notes: Ablation Related
Frequency: 1 affected / 299 at risk

Adverse event: Procedure related Genitourinary/Renal
Serious: no
Organ System: Surgical and medical procedures
Notes: Ablation Related
Frequency: 4 affected / 299 at risk

Adverse event: Procedure related Hypertension
Serious: no
Organ System: Surgical and medical procedures
Notes: Ablation Related
Frequency: 1 affected / 299 at risk

Adverse event: Procedure related Neurological (Non-TIA, non-stroke, dysphagia, speech disturbance/dysarthria)
Serious: no
Organ System: Surgical and medical procedures
Notes: Ablation Related
Frequency: 1 affected / 299 at risk

Adverse event: Procedure related Pulmonary (including cough, hemoptysis)
Serious: no
Organ System: Surgical and medical procedures
Notes: Ablation Related
Frequency: 1 affected / 299 at risk

Adverse event: Cerebrovascular accident
Serious: no
Organ System: Surgical and medical procedures
Notes: Ablation Related
Frequency: 1 affected / 299 at risk

Adverse event: Visual blurring/disturbances
Serious: no
Organ System: Surgical and medical procedures
Notes: Ablation Related
Frequency: 2 affected / 299 at risk

Adverse event: Atrial Fibrillation (AF)
Serious: no
Organ System: Cardiac disorders
Notes: Cardiovascular
Frequency: 7 affected / 299 at risk

Adverse event: Atrial flutter
Serious: no
Organ System: Cardiac disorders
Notes: Cardiovascular
Frequency: 1 affected / 299 at risk

Adverse event: Chest pain - Other
Serious: no
Organ System: Cardiac disorders
Notes: Cardiovascular
Frequency: 2 affected / 299 at risk

Adverse event: Distal thromboemboli
Serious: no
Organ System: Cardiac disorders
Notes: Cardiovascular
Frequency: 1 affected / 299 at risk

Adverse event: Multiple Heart Failure symptoms
Serious: no
Organ System: Cardiac disorders
Notes: Cardiovascular
Frequency: 1 affected / 299 at risk

Adverse event: Multiple symptoms
Serious: no
Organ System: Cardiac disorders
Notes: Cardiovascular
Frequency: 1 affected / 299 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Notes: Cardiovascular
Frequency: 1 affected / 299 at risk

Adverse event: Sinus bradycardia
Serious: no
Organ System: Cardiac disorders
Notes: Cardiovascular
Frequency: 1 affected / 299 at risk

Adverse event: Adverse reaction - Medication
Serious: no
Organ System: General disorders
Notes: Non-Cardiovascular
Frequency: 1 affected / 299 at risk

Adverse event: Fever and/or virus
Serious: no
Organ System: General disorders
Notes: Non-Cardiovascular
Frequency: 5 affected / 299 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: General disorders
Notes: Non-Cardiovascular
Frequency: 1 affected / 299 at risk

Adverse event: Genitourinary
Serious: no
Organ System: General disorders
Notes: Non-Cardiovascular
Frequency: 2 affected / 299 at risk

Adverse event: Hematological
Serious: no
Organ System: General disorders
Notes: Non-Cardiovascular
Frequency: 1 affected / 299 at risk

Adverse event: Neurological
Serious: no
Organ System: General disorders
Notes: Non-Cardiovascular
Frequency: 1 affected / 299 at risk