Study: NCT04382612

Adverse event: BLEEDING - INTRACARDIAC/INTRATHORACIC INJURY DURING INDEX PROCEDURE
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 42 at risk

Adverse event: ARRHYTHMIA - TACHYCARDIA - VENTRICULAR
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 42 at risk

Adverse event: ARRHYTHMIA - BRADYCARDIA
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 42 at risk

Adverse event: ARRHYTHMIA - PAROXYSMAL ATRIAL FIBRILLATION (PAF)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 42 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 42 at risk

Adverse event: Pericarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 42 at risk

Adverse event: REGURGITATION - RECURRENT MITRAL SEVERE
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 42 at risk

Adverse event: DEVICE SPECIFIC COMPLICATION - EPTFE KNOT PULL-OUT/DETACHMENT (FROM LEAFLET)
Serious: yes
Organ System: Product Issues
Frequency: 2 affected / 42 at risk

Adverse event: DEVICE SPECIFIC COMPLICATION - OTHER CHORD/KNOT STRUCTURAL PROBLEMS
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 42 at risk

Adverse event: ACUTE KIDNEY INJURY/RENAL INSUFFICIENCY
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 42 at risk

Adverse event: BONE FRACTURE/BREAK
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 42 at risk

Adverse event: OTHER - NONSPECIFIC
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 42 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 42 at risk

Adverse event: Atelectasis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 42 at risk

Adverse event: RESPIRATORY COMPLICATION - PNEUMOTHORAX
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 42 at risk

Adverse event: ACCESS SITE AND VASCULAR COMPLICATIONS - OTHER MINOR
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 42 at risk

Adverse event: ANEMIA - NON-BLEEDING RELATED
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 42 at risk

Adverse event: ARRHYTHMIA - PAROXYSMAL ATRIAL FIBRILLATION (PAF)
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 42 at risk

Adverse event: ARRHYTHMIA - BRADYCARDIA
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 42 at risk

Adverse event: ARRHYTHMIA - OTHER
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 42 at risk

Adverse event: REGURGITATION - RECURRENT MITRAL MODERATE
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 42 at risk

Adverse event: REGURGITATION - RECURRENT MITRAL SEVERE
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 42 at risk

Adverse event: DEVICE SPECIFIC COMPLICATION - EPTFE KNOT PULL-OUT/DETACHMENT (FROM LEAFLET)
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 42 at risk

Adverse event: MUSCULAR SKELETAL/DERMATOLOGIC - OTHER
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 42 at risk

Adverse event: NEUROLOGICAL EVENT - TRANSIENT ISCHEMIC ATTACK (TIA)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 42 at risk

Adverse event: INFECTION/INFLAMMATION - OTHER
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 42 at risk

Adverse event: OTHER - NONSPECIFIC
Serious: no
Organ System: General disorders
Frequency: 2 affected / 42 at risk

Adverse event: ALLERGIC REACTION - OTHER
Serious: no
Organ System: General disorders
Frequency: 1 affected / 42 at risk

Adverse event: FEVER - UNKNOWN ORIGIN
Serious: no
Organ System: General disorders
Frequency: 1 affected / 42 at risk

Adverse event: PSYCHIATRIC - OTHER
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 42 at risk

Adverse event: PSYCHIATRIC DISORDER
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 42 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 42 at risk

Adverse event: RESPIRATORY COMPLICATION - PNEUMOTHORAX
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 42 at risk

Adverse event: RESPIRATORY INFECTION - UPPER (URI)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 42 at risk

Adverse event: PULMONARY/RESPIRATORY - OTHER
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 42 at risk