Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2025-12-25 @ 7:46 PM
Study NCT ID:
NCT06783335
Status:
RECRUITING
Last Update Posted:
2025-11-19
First Post:
2025-01-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Real World Effectiveness of the Cordella Pulmonary Artery Sensor System in Patients With Chronic Heart Heart Failure
Sponsor:
Endotronix, Inc.
Organization:
Study Overview
Official Title:
The Real-World Effectiveness of The Cordella Pulmonary Artery Sensor System in Patients With Chronic Heart Failure: A Comparative Analysis to Standard of Care Pharmacologic Therapy
Status:
RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LOWER-PAP
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.
* 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: