Study: NCT01687166

Adverse event: AV Fistula
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 159 at risk

Adverse event: Alcohol dependency
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 159 at risk

Adverse event: Arrhythmia (Ablation Procedure)
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 159 at risk

Adverse event: Atrial fibrillation (AF)
Serious: yes
Organ System: Cardiac disorders
Frequency: 18 affected / 159 at risk

Adverse event: Atrial flutter (type 1 Isthmus Dependent)
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 159 at risk

Adverse event: Atrial tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 159 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 159 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 159 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 159 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 159 at risk

Adverse event: Cardiac tamponade/perforation
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 159 at risk

Adverse event: Cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 159 at risk

Adverse event: Cerebrovascular accident (CVA)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 159 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 159 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 159 at risk

Adverse event: Dizziness
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 159 at risk

Adverse event: Fluid volume overload( i.e. diuresis, electrolyte imbalance) (Ablation Procedure)
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 159 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 159 at risk

Adverse event: Genitourinary
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 8 affected / 159 at risk

Adverse event: Head, eyes, ears, nose, throat (HEENT)
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 159 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 159 at risk

Adverse event: Heart failure symptoms - Unspecified
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 159 at risk

Adverse event: Hematoma (Ablation Procedure)
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 159 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 159 at risk

Adverse event: Multiple heart failure symptoms
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 159 at risk

Adverse event: Multiple symptoms
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 159 at risk

Adverse event: Musculoskeletal
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 159 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 159 at risk

Adverse event: Pericardial Effusion (Ablation Procedure)
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 159 at risk

Adverse event: Pericarditis (Ablation Procedure)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 159 at risk

Adverse event: Premature atrial contractions (PAC)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 159 at risk

Adverse event: Pulmonary
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 159 at risk

Adverse event: Pulmonary Vein Stenosis - Significant (>70%)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 159 at risk

Adverse event: Pulmonary edema - Heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 159 at risk

Adverse event: Pulmonary embolism (PE)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 159 at risk

Adverse event: Abdominal wall haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 159 at risk

Adverse event: Renal
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 159 at risk

Adverse event: Sinus bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 159 at risk

Adverse event: Syncope
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 159 at risk

Adverse event: 1st degree AV block
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 159 at risk

Adverse event: Abnormal laboratory values
Serious: no
Organ System: General disorders
Frequency: 6 affected / 159 at risk

Adverse event: Adverse medication reaction
Serious: no
Organ System: General disorders
Frequency: 9 affected / 159 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: General disorders
Frequency: 1 affected / 159 at risk

Adverse event: Allergic reaction (Ablation Procedure)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 159 at risk

Adverse event: Anesthesia/Sedation related complication (Ablation Procedure)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 159 at risk

Adverse event: Angina pectoris
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 159 at risk

Adverse event: Arrhythmia (Ablation Procedure)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 159 at risk

Adverse event: Arterial/Venous Thromboembolic Events
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 159 at risk

Adverse event: Atrial fibrillation (AF)
Serious: no
Organ System: Cardiac disorders
Frequency: 22 affected / 159 at risk

Adverse event: Atrial flutter (type 1 Isthmus Dependent)
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 159 at risk

Adverse event: Atrial tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 11 affected / 159 at risk

Adverse event: Atrial flutter
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 159 at risk

Adverse event: Brugada syndrome
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 159 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 12 affected / 159 at risk

Adverse event: Cyst on ascending aorta
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 159 at risk

Adverse event: Dehydration
Serious: no
Organ System: General disorders
Frequency: 1 affected / 159 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 2 affected / 159 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 159 at risk

Adverse event: Dyspnea on exertion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 159 at risk

Adverse event: Edema (Ablation Procedure)
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 159 at risk

Adverse event: Endocrine
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 159 at risk

Adverse event: Epistaxis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 159 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 159 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 159 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 159 at risk

Adverse event: Gastroparesis (Ablation Procedure)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 159 at risk

Adverse event: Genitourinary
Serious: no
Organ System: Renal and urinary disorders
Frequency: 10 affected / 159 at risk

Adverse event: Groin pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 159 at risk

Adverse event: Head, eyes, ears, nose, throat (HEENT)
Serious: no
Organ System: General disorders
Frequency: 13 affected / 159 at risk

Adverse event: Hematological
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 159 at risk

Adverse event: Hematoma (Ablation Procedure)
Serious: no
Organ System: Vascular disorders
Frequency: 7 affected / 159 at risk

Adverse event: Hemorrhage (Ablation Procedure)
Serious: no
Organ System: General disorders
Frequency: 2 affected / 159 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 159 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 159 at risk

Adverse event: Integumentary
Serious: no
Organ System: General disorders
Frequency: 5 affected / 159 at risk

Adverse event: Intracardiac thrombus with no thromboembolic event
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 159 at risk

Adverse event: Junctional ectopic rhythm
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 159 at risk

Adverse event: Lyme disease
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 159 at risk

Adverse event: Multiple heart failure symptoms
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 159 at risk

Adverse event: Musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 159 at risk

Adverse event: Neurological
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 159 at risk

Adverse event: Nonsustained ventricular tachycardia (NSVT)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 159 at risk

Adverse event: Other SVT (AVRT, AVNRT, EAT etc.
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 159 at risk

Adverse event: Pain neuromuscular/non cardiovascular (Ablation Procedure)
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 159 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 159 at risk

Adverse event: Pericardial Effusion (Ablation Procedure)
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 159 at risk

Adverse event: Pericardial effusion
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 159 at risk

Adverse event: Pericardial effusion - Unrelated to procedure
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 159 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 159 at risk

Adverse event: Physical trauma
Serious: no
Organ System: General disorders
Frequency: 3 affected / 159 at risk

Adverse event: Premature atrial contractions (PAC)
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 159 at risk

Adverse event: Premature ventricular contractions (PVC)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 159 at risk

Adverse event: Psychological
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 159 at risk

Adverse event: Pulmonary
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 159 at risk

Adverse event: Pulmonary Vein Stenosis - Mild or Moderate (<70%)
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 159 at risk

Adverse event: Renal
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 159 at risk

Adverse event: Bundle branch block right
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 159 at risk

Adverse event: Sinus bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 159 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 8 affected / 159 at risk

Adverse event: Swollen groin
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 159 at risk

Adverse event: Syncope
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 159 at risk

Adverse event: Tachycardia (Ablation Procedure)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 159 at risk

Adverse event: Atrial flutter
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 159 at risk

Adverse event: Ventricular tachycardia (VT)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 159 at risk

Adverse event: Visual Blurring/Disturbances (Ablation Procedure)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 159 at risk

Adverse event: AV Fistula
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 167 at risk

Adverse event: Arrhythmia (Ablation Procedure)
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 167 at risk

Adverse event: Atrial fibrillation (AF)
Serious: yes
Organ System: Cardiac disorders
Frequency: 27 affected / 167 at risk

Adverse event: Atrial flutter (type 1 Isthmus Dependent)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 167 at risk

Adverse event: Atrial tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 167 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 167 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 167 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 167 at risk

Adverse event: Cardiac tamponade/perforation
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 167 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 167 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 167 at risk

Adverse event: Dizziness
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 167 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 167 at risk

Adverse event: Endocrine
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 167 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 167 at risk

Adverse event: Genitourinary
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 167 at risk

Adverse event: Head, eyes, ears, nose, throat (HEENT)
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 167 at risk

Adverse event: Hematoma (Ablation Procedure)
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 167 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 167 at risk

Adverse event: IV infiltrate
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 167 at risk

Adverse event: Musculoskeletal
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 167 at risk

Adverse event: Other SVT (AVRT, AVNRT, EAT etc.
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 167 at risk

Adverse event: Palpitations
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 167 at risk

Adverse event: Pericardial Effusion (Ablation Procedure)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 167 at risk

Adverse event: Psychological
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 167 at risk

Adverse event: Pulmonary
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 167 at risk

Adverse event: Sanguineous drainage
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 167 at risk

Adverse event: Sinus bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 167 at risk

Adverse event: Systemic infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 167 at risk

Adverse event: 1st degree AV block
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 167 at risk

Adverse event: 2nd degree AV block
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 167 at risk

Adverse event: Abnormal laboratory values
Serious: no
Organ System: General disorders
Frequency: 1 affected / 167 at risk

Adverse event: Adverse medication reaction
Serious: no
Organ System: General disorders
Frequency: 8 affected / 167 at risk

Adverse event: Allergic reaction (Ablation Procedure)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 167 at risk

Adverse event: Atrial fibrillation (AF)
Serious: no
Organ System: Cardiac disorders
Frequency: 32 affected / 167 at risk

Adverse event: Atrial flutter (type 1 Isthmus Dependent)
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 167 at risk

Adverse event: Atrial tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 167 at risk

Adverse event: Atrial flutter
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 167 at risk

Adverse event: Musculoskeletal discomfort
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 167 at risk

Adverse event: Breathing difficulties
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 167 at risk

Adverse event: Neoplasm malignant
Serious: no
Organ System: General disorders
Frequency: 1 affected / 167 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 167 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 167 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 7 affected / 167 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 167 at risk

Adverse event: Endocrine
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 167 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 167 at risk

Adverse event: Fluid retention
Serious: no
Organ System: General disorders
Frequency: 1 affected / 167 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 167 at risk

Adverse event: Genitourinary
Serious: no
Organ System: Renal and urinary disorders
Frequency: 10 affected / 167 at risk

Adverse event: Head, eyes, ears, nose, throat (HEENT)
Serious: no
Organ System: General disorders
Frequency: 12 affected / 167 at risk

Adverse event: Heart failure symptoms - Unspecified
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 167 at risk

Adverse event: Hematoma (Ablation Procedure)
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 167 at risk

Adverse event: Hemorrhage (Ablation Procedure)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 167 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 167 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 167 at risk

Adverse event: Hypotension (Ablation Procedure)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 167 at risk

Adverse event: Integumentary
Serious: no
Organ System: General disorders
Frequency: 3 affected / 167 at risk

Adverse event: Intracardiac thrombus with no thromboembolic event
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 167 at risk

Adverse event: Electrocardiogram QT prolonged
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 167 at risk

Adverse event: Musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 167 at risk

Adverse event: Neurological
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 167 at risk

Adverse event: Non-toxic LLE cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 167 at risk

Adverse event: Nonsustained ventricular tachycardia (NSVT)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 167 at risk

Adverse event: Other SVT (AVRT, AVNRT, EAT etc.
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 167 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 167 at risk

Adverse event: Pericardial Effusion (Ablation Procedure)
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 167 at risk

Adverse event: Peripheral edema - Heart failure
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 167 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 167 at risk

Adverse event: Physical trauma
Serious: no
Organ System: General disorders
Frequency: 2 affected / 167 at risk

Adverse event: Pleuritis (Ablation Procedure)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 167 at risk

Adverse event: Premature atrial contractions (PAC)
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 167 at risk

Adverse event: Premature ventricular contractions (PVC)
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 167 at risk

Adverse event: Psychological
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 167 at risk

Adverse event: Pulmonary
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 167 at risk

Adverse event: Pulmonary Vein Stenosis - Significant (>70%)
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 167 at risk

Adverse event: Sinus arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 167 at risk

Adverse event: Sinus bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 167 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 167 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 167 at risk

Adverse event: Atrial flutter
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 167 at risk

Adverse event: Vagal denervation symptoms
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 167 at risk

Adverse event: AV Fistula
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 51 at risk

Adverse event: Adverse medication reaction
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 51 at risk

Adverse event: Arrhythmia (Ablation Procedure)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 51 at risk

Adverse event: Atrial fibrillation (AF)
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 51 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 51 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 51 at risk

Adverse event: Chest pain - Heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 51 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 51 at risk

Adverse event: Endocrine
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 51 at risk

Adverse event: Fluid volume overload( i.e. diuresis, electrolyte imbalance) (Ablation Procedure)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 51 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 51 at risk

Adverse event: Head, eyes, ears, nose, throat (HEENT)
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 51 at risk

Adverse event: Heart failure symptoms - Unspecified
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 51 at risk

Adverse event: Hematoma (Ablation Procedure)
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 51 at risk

Adverse event: Hiccups
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 51 at risk

Adverse event: Multiple heart failure symptoms
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 51 at risk

Adverse event: Musculoskeletal
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 51 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 51 at risk

Adverse event: Palpitations
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 51 at risk

Adverse event: Pericarditis (Ablation Procedure)
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 51 at risk

Adverse event: Pulmonary
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 51 at risk

Adverse event: Renal
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 51 at risk

Adverse event: Renal insufficiency - Heart failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 51 at risk

Adverse event: AV Fistula
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 51 at risk

Adverse event: Abnormal laboratory values
Serious: no
Organ System: General disorders
Frequency: 2 affected / 51 at risk

Adverse event: Adverse medication reaction
Serious: no
Organ System: General disorders
Frequency: 3 affected / 51 at risk

Adverse event: Anesthesia/Sedation related complication (Ablation Procedure)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 51 at risk

Adverse event: Aortic root atheromatosis
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 51 at risk

Adverse event: Arrhythmia (Ablation Procedure)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 51 at risk

Adverse event: Atrial fibrillation (AF)
Serious: no
Organ System: Cardiac disorders
Frequency: 12 affected / 51 at risk

Adverse event: Atrial flutter (type 1 Isthmus Dependent)
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 51 at risk

Adverse event: Musculoskeletal discomfort
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 51 at risk

Adverse event: Bradycardia with pauses
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 51 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 51 at risk

Adverse event: Chest pain - Ischemic
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 51 at risk

Adverse event: Cirrhosis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 51 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 51 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 2 affected / 51 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 51 at risk

Adverse event: Edema (Ablation Procedure)
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 51 at risk

Adverse event: Exacerbation of existing condition (Ablation Procedure)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 51 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 51 at risk

Adverse event: Fluid retention
Serious: no
Organ System: General disorders
Frequency: 1 affected / 51 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 51 at risk

Adverse event: Genitourinary
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 51 at risk

Adverse event: Groin bleed (Ablation Procedure)
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 51 at risk

Adverse event: Head, eyes, ears, nose, throat (HEENT)
Serious: no
Organ System: General disorders
Frequency: 3 affected / 51 at risk

Adverse event: Hematoma (Ablation Procedure)
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 51 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 51 at risk

Adverse event: Increased GERD
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 51 at risk

Adverse event: Integumentary
Serious: no
Organ System: General disorders
Frequency: 1 affected / 51 at risk

Adverse event: Intraventricular conduction delay
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 51 at risk

Adverse event: Junctional ectopic rhythm
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 51 at risk

Adverse event: Musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 51 at risk

Adverse event: Neurological
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 51 at risk

Adverse event: Other SVT (AVRT, AVNRT, EAT etc.
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 51 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 51 at risk

Adverse event: Pericardial Effusion (Ablation Procedure)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 51 at risk

Adverse event: Pericardial effusion - Unrelated to procedure
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 51 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 51 at risk

Adverse event: Physical trauma
Serious: no
Organ System: General disorders
Frequency: 1 affected / 51 at risk

Adverse event: Pleuritis (Ablation Procedure)
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 51 at risk

Adverse event: Premature atrial contractions (PAC)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 51 at risk

Adverse event: Premature ventricular contractions (PVC)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 51 at risk

Adverse event: Vascular pseudoaneurysm
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 51 at risk

Adverse event: Pulmonary
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 51 at risk

Adverse event: Pulmonary Vein Stenosis - Mild or Moderate (<70%)
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 51 at risk

Adverse event: Renal
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 51 at risk

Adverse event: Bundle branch block right
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 51 at risk

Adverse event: Sinus bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 51 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 51 at risk

Adverse event: Thrombus (No embolism) (Ablation Procedure)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 51 at risk