Study: NCT04250714

Adverse event: 3rd degree AV block
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 399 at risk

Adverse event: Angina/Chest pain
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 399 at risk

Adverse event: Atrial Fibrillation (AF)
Serious: yes
Organ System: Cardiac disorders
Notes: Including Atrial Fibrillation (AF) paroxysmal, AF persistent, AF recurrence, Atrial Tachycardia, hospital admission for AF
Frequency: 17 affected / 399 at risk

Adverse event: Implantation LBB Pacemaker
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 399 at risk

Adverse event: Atrial Flutter (AFl)
Serious: yes
Organ System: Cardiac disorders
Notes: Including palpitations and hospital admissions
Frequency: 4 affected / 399 at risk

Adverse event: Atrial tachycardia/Other supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Notes: AV-nodal re-entry tachycardia (AVNRT), supraventricular tachycardia
Frequency: 2 affected / 399 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Intestine Cancer, Lobectomy, Suspicion of a carcinoid in the intestine, uterus cancer surgery and whipple/ (Endoscopic retrograde cholangiopancreatography) ERCP
Frequency: 4 affected / 399 at risk

Adverse event: CerebroVascular Accident (CVA)
Serious: yes
Organ System: Vascular disorders
Notes: benign paroxysmal position dizziness, ischemia
Frequency: 2 affected / 399 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Notes: Chest pain, instable angina pectoris
Frequency: 2 affected / 399 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Vascular disorders
Notes: Coronary angiographia; electiv Recanalisation, actually without symptoms; Exclusion progress Coronary Artery Disease (CAD); Left main coronary artery intrastent restenosis
Frequency: 4 affected / 399 at risk

Adverse event: Dizziness
Serious: yes
Organ System: General disorders
Notes: domestic fall in benign positional vertigo
Frequency: 1 affected / 399 at risk

Adverse event: Dyspnea - Heart Failure
Serious: yes
Organ System: Cardiac disorders
Notes: Hisbundel Ablation
Frequency: 1 affected / 399 at risk

Adverse event: Embolism - Air
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: ST elevation during ablation procedure.
Frequency: 1 affected / 399 at risk

Adverse event: Endocrine
Serious: yes
Organ System: Endocrine disorders
Notes: Hyperthyroid struma multinodosa both sides; Parathyroidectomie
Frequency: 2 affected / 399 at risk

Adverse event: COVID19 infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 399 at risk

Adverse event: Fistula (Aterial/Venous)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Arteriovenous fistula; Fistula; Pain on the right femoral fistula; Right femoral arterio-venous fistula with hematoma
Frequency: 3 affected / 399 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Dyspnoe
Frequency: 1 affected / 399 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Notes: abdominal abces; Abdominal pain right lower abdomen; ileus, hernia umbilicalis; suspected appendicitis
Frequency: 4 affected / 399 at risk

Adverse event: Genitourinary
Serious: yes
Organ System: Renal and urinary disorders
Notes: urinary bladder tumor resection
Frequency: 1 affected / 399 at risk

Adverse event: Head, Eyes, Ears, Nose, Throat (HEENT)
Serious: yes
Organ System: General disorders
Notes: Cholesteatom right; nervus opticus inflammation;
Frequency: 2 affected / 399 at risk

Adverse event: Heart Failure symptoms - Unspecified
Serious: yes
Organ System: Cardiac disorders
Notes: CRT-D (cardiac resynchronization therapy - defibrillator) implant; worsening heart failure
Frequency: 2 affected / 399 at risk

Adverse event: Hematological
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Anemia
Frequency: 1 affected / 399 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: IHematoma, hematoma inguinal area, subcutaneous hematoma
Frequency: 3 affected / 399 at risk

Adverse event: Hypertension/Hypertensive Crisis
Serious: yes
Organ System: Vascular disorders
Notes: Hypertensive derailement
Frequency: 2 affected / 399 at risk

Adverse event: Integumentary
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Fever, melanoma of the skin
Frequency: 2 affected / 399 at risk

Adverse event: Musculoskeletal
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: carpal tunnel syndrom
Frequency: 1 affected / 399 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Post interventional STEMI (ST segment elevation myocardial infarction)
Frequency: 1 affected / 399 at risk

Adverse event: Myocardial perforation with tamponade
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: drained tamponade, pericardial effusion
Frequency: 2 affected / 399 at risk

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Notes: ICD (implantable cardioverter defibrillator) Shock
Frequency: 1 affected / 399 at risk

Adverse event: Oozing/Bleeding
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Bleeding; Groin access site hematoma
Frequency: 2 affected / 399 at risk

Adverse event: Non Cardiovascular Pain
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: chest pain due to gastric problems
Frequency: 1 affected / 399 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: right ventricular effusion
Frequency: 1 affected / 399 at risk

Adverse event: Phrenic nerve injury temporary
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 399 at risk

Adverse event: Physical trauma
Serious: yes
Organ System: General disorders
Notes: Hand Fracture; Fracture of the neck and femur; right upper and lower limb motor deficit; spinal fracture following trauma; wound dehiscence
Frequency: 4 affected / 399 at risk

Adverse event: Procedure related Allergic reactions/Adverse drug reaction
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Bradycardy, Dizziness; Bronchospasm
Frequency: 2 affected / 399 at risk

Adverse event: Procedure related Pulmonary (including cough, hemoptysis)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Hospital admission with AF,heamoptysis and fever
Frequency: 1 affected / 399 at risk

Adverse event: Vascular pseudoaneurysm
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 399 at risk

Adverse event: Pulmonary
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: acute dyspnea; Pneumonia with exacerbated COPD (Chronic Obstructive Pulmonary Disease); pneumopathy
Frequency: 2 affected / 399 at risk

Adverse event: Left renal colic
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 399 at risk

Adverse event: Sinus tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 399 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: cerebellar infarctation left
Frequency: 1 affected / 399 at risk

Adverse event: Syncope
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 399 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Femoral vein thrombosis
Frequency: 1 affected / 399 at risk

Adverse event: Transient Ischemic Attack (TIA)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 399 at risk

Adverse event: Pectoralis twitching due to pacemaker
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 399 at risk

Adverse event: Ventricular Tachycardia (VT)/Monomorphic VT
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 399 at risk

Adverse event: Vessel trauma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: hematic leakage from collateral femoral artery
Frequency: 1 affected / 399 at risk

Adverse event: Angina/Chest pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: atypic thorax pain; Dyspnoe d'effort
Frequency: 2 affected / 399 at risk

Adverse event: Atrial Fibrillation (AF)
Serious: no
Organ System: Cardiac disorders
Notes: Atrial fibrillation (AF); Hospital admission with AF; repeat ablation procedure
Frequency: 4 affected / 399 at risk

Adverse event: Atrial flutter
Serious: no
Organ System: Cardiac disorders
Notes: tachycardia-like palpitations; Atrial flutter; Atypical Atrial flutter
Frequency: 3 affected / 399 at risk

Adverse event: Deep Vein Thrombosis (DVT)
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 399 at risk

Adverse event: Dyspnea - Heart Failure
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 399 at risk

Adverse event: Embolism - Air
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 399 at risk

Adverse event: Gastritis
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: stomach ache; GERD (Gastroesophageal reflux disease) exacerbation
Frequency: 2 affected / 399 at risk

Adverse event: Impaired gastric emptying
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 399 at risk

Adverse event: Haematoma
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 399 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 399 at risk

Adverse event: Oozing/Bleeding
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 399 at risk

Adverse event: Pain (Non-cardiovascular)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 399 at risk

Adverse event: Pain cardiovascular (Non-ischemic)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 399 at risk

Adverse event: Pericarditis
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 399 at risk

Adverse event: Phrenic nerve injury permanent
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 399 at risk

Adverse event: Phrenic nerve injury temporary
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 399 at risk

Adverse event: Procedure related Allergic reactions/Adverse drug reaction
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 399 at risk

Adverse event: Procedure related Anesthesia/Sedation
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Keratitis
Frequency: 1 affected / 399 at risk

Adverse event: Procedure related Gastrointestinal
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Abdominal pain
Frequency: 2 affected / 399 at risk

Adverse event: Procedure related Hypotension
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 399 at risk

Adverse event: Procedure related Neurological (Non-TIA, non-stroke, dysphagia, speech disturbance/dysarthria)
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: visual disturbance; migraine
Frequency: 3 affected / 399 at risk

Adverse event: Procedure related Pulmonary (including cough, hemoptysis)
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Dyspnoe, hemoptysis
Frequency: 3 affected / 399 at risk

Adverse event: Vascular pseudoaneurysm
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 399 at risk

Adverse event: Psychological issues related to Phrenic Nerve Injury (PNI)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 399 at risk

Adverse event: Sinus bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 399 at risk

Adverse event: Visual blurring/Disturbances
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 399 at risk