Event Group
Event Groups are part of the Adverse Events Module within the Results Section. They provide a way to organize and summarize adverse event data by grouping related events together.
Each Event Group typically represents a category or class of adverse events and includes statistical information such as the number of participants affected and at risk for different event types: deaths, serious events, and other events.
Event Group path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Group
Event Group
Ignite Creation Date:
2025-12-24 @ 3:00 PM
Ignite Modification Date:
2025-12-25 @ 1:24 PM
NCT ID:
NCT04089059
Group ID:
EG000
Title:
Intent-to-Treat (ITT)
Description:
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)
Deaths Number Affected:
33
Deaths Number At Risk:
None
Serious Number Affected:
278
Serious Number At Risk:
493
Other Number Affected:
379
Other Number At Risk:
493
Study:
NCT04089059
Results Section:
NCT04089059
Adverse Events Module:
NCT04089059