Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2025-12-24 @ 10:10 PM
NCT ID:
NCT06783335
Brief Summary:
This retrospective, non-randomized cohort study will evaluate how well the Cordella PA Sensor System works compared to standard medication treatment in people with chronic heart failure. The study will track patients for two years to see if those using the Cordella system have fewer deaths and hospitalizations related to heart failure.
Detailed Description:
The study will compare two groups of patients with chronic heart failure:
* One group will use the Cordella PA Sensor System, which monitors heart pressure from home
* The other group will receive standard heart failure medications without a pressure monitoring system
The main goal is to see if patients using the Cordella system have fewer heart failure-related hospital stays and a lower death rate over a two-year period. The study will look especially closely at results for:
* Men and women separately
* Patients with different types of heart failure (preserved or reduced heart function)
* Patients aged 75 and older
* Different racial and ethnic groups
* Patients with kidney disease
* Patients with existing heart devices
The study will use real-world data from:
* Patients using the Cordella system in routine medical care
* Similar patients receiving standard care, identified through medical records and insurance claims Both groups of patients will be carefully matched to ensure they are similar in age, gender, and other important factors that could affect the results.
Study:
NCT06783335
Study Brief:
Protocol Section:
NCT06783335