Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-24 @ 6:40 PM
Ignite Modification Date: 2025-12-25 @ 4:11 PM
NCT ID: NCT00779857
Description: An independent Physician Adjudicator adjudicated all site reported adverse events and assessed them for seriousness and attribution to the device or the procedure. The results of the adjudication served as the basis for the summary tabulations of adverse events, including the primary safety endpoint.
Frequency Threshold: 5
Time Frame: Adverse events were collection from Date of Procedure through 24 month Post Procedure Follow-up.
Study: NCT00779857
Study Brief: AtriCure Exclusion of the LAA in Patients Undergoing Concomitant Cardiac Surgery
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
AtriCure LAA Exclusion System AtriCure LAA Exclusion System AtriCure LAA Exclusion System : Exclusion of the left atrial appendage using the AtriCure LAA Exclusion System None None 35 70 63 70 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Heparin-Induced Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Atrial Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atrial Flutter SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atrioventricular Block SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atrioventricular Block Complete SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac Failure Congestive SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Low Cardiac Output Syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Sinoatrial Block SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Ventricular Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Ventricular Septal Defect Acquired SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Gastrointestinal Haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
General Physical Health Deterioration SYSTEMATIC_ASSESSMENT General disorders None View
Oedema SYSTEMATIC_ASSESSMENT General disorders None View
Bile Duct Stone SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Bacteriaemia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Incision Site Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Drug Administration Error SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Drug Toxicity SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Operative Haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Post Procedural Haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Toxic Encephalopathy SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Traumatic Lung Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Ejection Fraction Decreased SYSTEMATIC_ASSESSMENT Investigations None View
Cerebrovascular Accident SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Phrenic Nerve Paralysis SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Mental Status Changes SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Renal Failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Atelectasis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pleural Effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pleuritic Pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pulmonary Embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Respiratory Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Aortic Dissection SYSTEMATIC_ASSESSMENT Vascular disorders None View
Deep Vein Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Haemorrhage SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Atrial Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atrioventricular Block Complete SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac Failure Congestive SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Renal Failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Pleural Effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Haemorrhage SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Post Procedural Haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Respiratory Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View