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:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-26 @ 12:04 AM
NCT ID:
NCT05443594
Description:
None
Frequency Threshold:
0
Time Frame:
Through Day 360
Study:
NCT05443594
Study Brief:
A Prospective Single Arm Open Label Study of the FARAPULSE Pulsed Field Ablation System in Subjects With Persistent Atrial Fibrillation
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Pulsed Field Ablation (Phase 1) Non-Roll In Treatment Subjects | PHASE 1 only Phase 1: FARAPULSE Ablation System - Pulsed Field Ablation (PFA) to isolate the Pulmonary Veins and Posterior Wall using the FARAWAVE PFA Catheter. | 0 | None | 44 | 260 | 82 | 260 | View |
| Pulsed Field Ablation (Phase 2) Non-Roll In Treatment Subjects | Phase 2 only Phase 2: FARAPULSE Ablation System - Pulsed Field Ablation (PFA) to isolate the Pulmonary Veins and Posterior Wall using the FARAWAVE PFA Catheter and FARAPOINT PFA Catheter for cavo-tricuspid isthmus (CTI) ablation. | 2 | None | 53 | 255 | 76 | 255 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| 2nd degree AV block | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Abnormal laboratory values | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Adverse reaction-Medication | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Atrial Fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Atrial Flutter | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Major bleeding/Hemorrhage requiring transfusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Musculoskeletal | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Myocardial infarction | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Myocardial perforation with tamponade | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Stroke | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Atrial tachycardia/ Other SVT (AVRT, AVNRT, EAT) | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Cancer | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Cerebrovascular Accident (CVA) | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Cerebrovascular Accident (CVA)- Hemorrhagic | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Coronary artery Disease | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Coronary artery injury/ spasm | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Exacerbation of existing condition | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Fluid volume overload | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Gastrointestinal | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Genitourinary | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Hematoma - Unrelated procedure/device | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Localized infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Physical Trauma | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Pleural effusion - unrelated procedure/ device | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Post procedure infection/ sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Procedure related Anesthesia/ sedation | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Procedure related Genitourinary/ renal | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Procedure related heart failure | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Procedure related hypotension | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Procedure related Neurological (Non-TIA, non-stroke, dysphagia, speech disturbance/ dysarthria) | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Procedure related Pulmonary (including cough, hemoptysis) | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Psychological | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| ST segment elevation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Thrombus | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Valvular damage/ valvular insufficiency | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| AV block (Transient) | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Chest pain - Other | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Dyspnea - Heart Failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Embolism - Air | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Head, Eyes, Ears, Nose, Throat (HEENT) | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Hemolysis (laboratory confirmed) | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Hemolysis high suspicion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Hypertension/Hypertensive crisis | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Hypotension/Orthostatic hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Impaired Mobility | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Infection - Unrelated procedure/device | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Neurological | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Pericardial effusion - Unrelated procedure/device | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Post-surgical pocket hemorrhage/bleeding/drainage | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Procedure related Abnormal labs | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Procedure related Fatigue/Weakness | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Procedure related Genitourinary | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Procedure related Renal | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Pulmonary | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Sinus bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Vasovagal reaction | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Physical trauma | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Psychological | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Hernia | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Edema | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| AV block (permanent) | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Atrial Fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Atrial flutter | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Atrial tachycardia/ Other SVT(AVRT, AVNRT, EAT) | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Chest pain - Ischemic | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Fatigue/ weakness | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Hypertension/ hypertensive crisis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Multiple heart failure symptoms | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Peripheral edema - Heart Failure | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Sinus bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Cancer | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Genitourinary | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Localized infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Pulmonary | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| 1st degree AV block | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Adverse reaction - Medication | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Angina/Chest pain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Atrial flutter, not specified | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Bruising access site | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Cerebrovascular Accident (CVA) - Hemorrhagic | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Chest pain - Ischemic | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Edema | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Erosion | SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Fever and/or virus | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Fluid volume overload | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Gastrointestinal | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Headache | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Heart Failure symptoms - Unspecified | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Hematological | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Hematoma | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Hemolysis (Laboratory confirmed) | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Hiccups | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Inadequate healing of incision site | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Musculoskeletal | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Non-Sustained Ventricular Tachycardia (NSVT) | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Non-symptomatic pericardial effusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Oozing/Bleeding | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Pain (Non-cardiovascular) | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Pain cardiovascular (Non-ischemic) | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Pericarditis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Pericarditis | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Phrenic nerve injury temporary | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Post procedure infection/sepsis | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Post procedure wound discomfort | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Post -surgical infection (<=30 days post implant) | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Post surgical wound discomfort/bruising/swelling | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Post-surgical pocket hemorrhage/bleeding/drainage | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Procedure related Abnormal labs | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Procedure related Allergic reactions/Adverse drug reaction | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Procedure related Anesthesia/Sedation | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Procedure related Gastrointestinal | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Procedure related Genitourinary | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Procedure related Genitourinary/Renal | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Procedure related Heart Failure | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Procedure related Hypertension | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Procedure related Hypotension | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Procedure related Neurological (Non-TIA, non-stroke, dysphagia, speech disturbance/dysarthria) | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Procedure related Pulmonary (including cough, hemoptysis) | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Pulmonary edema | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Stroke | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Symptomatic pericardial effusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Vasovagal | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Visual blurring/disturbances, Migraine | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |