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 @ 3:00 PM
Ignite Modification Date:
2025-12-25 @ 1:24 PM
NCT ID:
NCT04089059
Description:
The event is an SAE when the patient outcome is:
* Death
* Life-threatening
* Hospitalization (initial or prolonged)
* Disability or permanent change
* Congenital Anomaly/Birth Defect
* Required Intervention to Prevent Permanent Impairment or Damage
* Other Serious (Important Medical Events) A planned hospitalization for a pre-existing condition, or a procedure required by the protocol, without a serious deterioration in health, is not considered to be a serious adverse event.
Frequency Threshold:
0
Time Frame:
12 months
Study:
NCT04089059
Study Brief:
PROACTIVE-HF IDE Trial Heart Failure NYHA Class III
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Intent-to-Treat (ITT) | Received standard of care heart failure management (i.e., Guideline Directed Medical Therapy) and Pulmonary Artery Pressure Guided Heart Failure Management (PAPGHFM) using the Cordella Heart Failure System (CHFS) with the PA pressure sensor OR withdrew from trial and did not receive an implant. To capture safety of all patients in the trial, the ITT sample was used in all safety analyses. In contrast, the mITT sample was used in all efficacy analyses as, as only mITT patients received the active treatment. See participant flow section for more details. Cordella™ Pulmonary Artery Sensor System: The Cordella PA Sensor System (CorPASS) is intended to measure, record, and transmit pulmonary artery pressure (PAP) data from NYHA Class III heart failure patients at home to clinicians for assessment and patient-centered heart failure management and comprises of seven subsystems that operate together to take daily Pulmonary Artery Pressure (PAP) readings at a patient's home and transmit the results to a care provider for evaluation. 1. Cordella Sensor 2. Cordella Delivery System 3. myCordella Patient Reader 4. Reader Dock 5. Cordella Calibration Equipment (CalEQ) 6. myCordella Hub 7. Cordella Data Analysis Platform (CDAP) | 33 | None | 278 | 493 | 379 | 493 | View |
| Former Control Arm | Received standard of care heart failure management (i.e., Guideline Directed Medical Therapy) using the Cordella Heart Failure System (CHFS) excluding the PA pressure sensor until the trial redesign. After trial redesign were crossed over to receive standard of care HF management using the Cordella HF system with the PA pressure sensor. | 5 | None | 47 | 72 | 60 | 72 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Heart Failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Emergency Department Visit | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Hospitalization | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Urgent, Unscheduled Outpatient Office/ Practice | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Acute Kidney Injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Bleeding | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Conduction Disturbances and Arrhythmias | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Hemoptysis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Myocardial Infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Pulmonary Embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Pulmonary Occlusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Renal Dysfunction | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Stroke and Trans Ischemic Attack | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Vascular Access Site and Access-Related Complications | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Vessel Trauma | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Other | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Blood and lymphatic system disorders | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Cardiac disorders | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Ear and labyrinth disorders | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | None | View |
| Gastrointestinal disorders | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| General disorders and administration site conditions | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Hepatobiliary disorders | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | None | View |
| Immune system disorders | SYSTEMATIC_ASSESSMENT | Immune system disorders | None | View |
| Infections and infestations | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Injury, poisoning and procedural complications | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Investigations | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Metabolism and nutrition disorders | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Musculoskeletal and connective tissue disorders | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Nervous system disorders | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Product issues | SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| Psychiatric disorders | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Renal and urinary disorders | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Respiratory, thoracic and mediastinal disorders | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Skin and subcutaneous tissue disorders | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Surgical and medical procedures | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Vascular disorders | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Reproductive system and breast disorders | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| Endocrine Disorders | SYSTEMATIC_ASSESSMENT | Endocrine disorders | None | View |
| Social Circumstances | SYSTEMATIC_ASSESSMENT | Social circumstances | None | View |
| Congential, Familial, and Genetic Disorders | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | None | View |
| Eye Disorders | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |