RecruitingNCT06783335

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

Sponsor

Endotronix, Inc.

Enrollment

2,150 participants

Start Date

Feb 7, 2025

Study Type

OBSERVATIONAL

Conditions

Heart Failure Heart Failure NYHA Class III

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is examining real-world outcomes of a small implantable sensor called the Cordella Pulmonary Artery Sensor System, which is placed in the heart to continuously monitor blood pressure in the lungs. This data helps doctors adjust heart failure medications before symptoms worsen, potentially reducing hospitalizations. **You may be eligible if...** - You have received the Cordella PA sensor implant between October 2024 and December 2029 - You have chronic, Class III (moderately severe) heart failure with symptoms - You are on guideline-recommended heart failure medications and have continuous health insurance for at least 12 months **You may NOT be eligible if...** - You have a different type of implanted monitoring device already in place - You do not meet the insurance continuity or medication requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICECordella 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

DRUGStandard 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

Locations(1)

Endotronix

Naperville, Illinois, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06783335

Related Trials

A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Heart Failure

NCT06424288653 locations

A Study to Test Whether Vicadrostat (BI 690517) in Combination With Empagliflozin Helps People With Heart Failure and a Weak Pumping Function of the Left Side of the Heart

NCT06935370638 locations

Impact of Optimized Pacing Strategies on Clinical and Hemodynamic Outcomes in Heart Failure Patients With Pacemaker

NCT075631531 location

A Study to Learn About the Study Medicine Called PF-07328948 in Adults With Heart Failure (BRANCH-HF)

NCT06991257135 locations

The Salt Study for Heart Failure

NCT075605921 location