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Clinical Trials in the USA / NCT06783335
Recruiting Observational

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

NCT06783335 · tracked via the Priya Life Science USA tracker
Sponsor
Endotronix, Inc.
Phase
Observational
Started
2025-02-07
Last updated
2025-11-19

Condition(s) studied

Heart Failure NYHA Class IIIHeart Failure

Investigational drug(s) / intervention(s)

Cordella PA Sensor SystemStandard of Care Pharmacologic Therapy

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

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

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria for Cordella PA Sensor System Cohort: * 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 Inclusion Criteria for Standard of Care Control Cohort: * 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 Criteria: * 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)

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Endotronix Naperville Illinois Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06783335 on ClinicalTrials.gov ↗ ← All trials in the USA