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

Inclusion Criteria12

Received Cordella PA Sensor System implant between 10/1/2024-12/31/2029
Documented chronic heart failure with NYHA Class III symptoms
On guideline-directed medical therapy based on ejection fraction status:
For reduced EF (≤40%): At least one fill of ACE/ARB/ARNI, MRA, BB, or SGLT2i, and one fill of a loop diuretic
For preserved EF (\>40%): At least one fill of a loop diuretic
Has continuous health insurance enrollment for 12 months prior to implant
Two or more encounters with diagnosis codes for chronic systolic and/or diastolic heart failure
Documented ejection fraction reading within 6 months (+ or -) of second heart failure encounter
On guideline-directed medical therapy based on ejection fraction status:
For reduced EF (≤40%): At least one fill of ACE/ARB/ARNI, MRA, BB, or SGLT2i, and one fill of a loop diuretic
For preserved EF (\>40%): At least one fill of a loop diuretic
Has continuous health insurance enrollment for 12 months prior to study entry

Exclusion Criteria6

No implanted pulmonary artery sensor or monitoring at any time (Standard of Care Control Cohort only)
Record of temporary mechanical circulatory support during baseline period
Diagnosis of cardiogenic shock during baseline period
Receiving palliative care/hospice during baseline period
Record of end-stage renal disease during baseline period
Unable to take dual antiplatelet therapy or anticoagulants for one month post implant (Cordella Cohort only)

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