Study: NCT02768870

Adverse event: Arrhythmia - Persistent atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 26 at risk

Adverse event: Nonspecific, unknown, or other body system - Other complication
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 26 at risk

Adverse event: ePTFE cordal rupture
Serious: yes
Organ System: Product Issues
Frequency: 5 affected / 26 at risk

Adverse event: Blood sepsis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 26 at risk

Adverse event: Cardiovascular - Other
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 26 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 26 at risk

Adverse event: Pleural effusion - Left
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Regurgitation - Mitral-indeterminate +4
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 26 at risk

Adverse event: DAMAGE TO THE NATIVE MITRAL VALVE APPARATUS CHORD
Serious: yes
Organ System: Product Issues
Frequency: 2 affected / 26 at risk

Adverse event: BLEEDING - NEUROLOGICAL - MINOR (E.G. CVA)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 26 at risk

Adverse event: REGURGITATION - MITRAL-INDETERMINATE +2
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 26 at risk

Adverse event: CANCER - NEWLY DIAGNOSED
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 26 at risk

Adverse event: MUSCULAR SKELETAL/DERMATOLOGIC - OTHER
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 26 at risk

Adverse event: BLEEDING - CARDIOVASCULAR - MAJOR
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 26 at risk

Adverse event: ARRHYTHMIA - ATRIAL FLUTTER
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 26 at risk

Adverse event: PERFORATION, TEAR OR INJURY - VENTRICULAR MAJOR
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 26 at risk

Adverse event: Nonspecific, unknown, or other body system - Other complication
Serious: no
Organ System: General disorders
Frequency: 7 affected / 26 at risk

Adverse event: Arrhythmia - AV block - 1st degree
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 26 at risk

Adverse event: Genitourinary - Other
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 26 at risk

Adverse event: MUSCULAR SKELETAL/DERMATOLOGIC - OTHER
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 26 at risk

Adverse event: BLOOD/LYMPHATIC - OTHER
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 26 at risk

Adverse event: ANEMIA - NON-BLEEDING RELATED
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 26 at risk

Adverse event: ARRHYTHMIA - PAROXYSMAL ATRIAL FIBRILLATION (PAF)
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 26 at risk

Adverse event: ARRHYTHMIA - AV BLOCK - 3RD DEGREE
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 26 at risk

Adverse event: ARRHYTHMIA - BUNDLE BRANCH BLOCK - LEFT
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 26 at risk

Adverse event: ARRHYTHMIA - TACHYCARDIA - VENTRICULAR
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 26 at risk

Adverse event: REGURGITATION - MITRAL-INDETERMINATE +1
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 26 at risk

Adverse event: REGURGITATION - MITRAL-INDETERMINATE +2
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 26 at risk

Adverse event: REGURGITATION - MITRAL-INDETERMINATE +3
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 26 at risk

Adverse event: REGURGITATION - MITRAL-INDETERMINATE +4
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 26 at risk

Adverse event: URINARY TRACT INFECTION (UTI)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 26 at risk

Adverse event: INFECTION/INFLAMMATION - OTHER
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 26 at risk

Adverse event: METABOLIC COMPLICATIONS
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 26 at risk

Adverse event: STERNAL WOUND/THORACIC INFECTION
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 26 at risk

Adverse event: WOUND INFECTION - OTHER
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 26 at risk

Adverse event: PLEURAL EFFUSION - LEFT
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: RESPIRATORY FAILURE - OTHER
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: RESPIRATORY FAILURE - PNEUMOTHORAX
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: RESPIRATORY INFECTION - UPPER (URI)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 26 at risk