NCT06783335

Real World Effectiveness of the Cordella Pulmonary Artery Sensor System in Patients With Chronic Heart Heart Failure

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
• Phase: —
• Study type: Observational
• Enrollment: 2,150 (estimated)
• Sponsor: Endotronix, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Failure NYHA Class III
• Heart Failure

Interventions

Type	Name	Description
DEVICE	Cordella PA Sensor System	* Patients who receive the Cordella PA Sensor System for monitoring chronic heart failure * These patients will be monitored for 2 years after receiving the device * Patients must be on guideline-directed medical therapy appropriate for their ejection fraction status
DRUG	Standard of Care Pharmacologic Therapy	* Patients with chronic heart failure who receive standard medical care without PA pressure monitoring * These patients will be monitored for 2 years * Patients must be on guideline-directed medical therapy appropriate for their ejection fraction status

Timeline

• Start date: 2025-02-07
• Primary completion: 2030-12-31
• Completion: 2030-12-31
• First posted: 2025-01-20
• Last updated: 2025-11-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study