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

Launched by ENDOTRONIX, INC. · Jan 14, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of a device called the Cordella Pulmonary Artery Sensor System in patients with chronic heart failure, specifically those with moderate symptoms (known as NYHA Class III). The goal is to find out if this system helps patients avoid hospital visits and reduces the risk of death compared to standard medication treatments. Participants will be followed for two years to see how well the Cordella system performs in managing their heart condition.

To be eligible for this study, participants must have received the Cordella device between October 2024 and December 2029 and have been diagnosed with chronic heart failure. They also need to be on specific heart medications based on their heart function. Those in the control group, who will receive standard care, must have a history of heart failure and meet similar medication criteria. Participants can expect regular check-ups and monitoring over the study period, and everyone involved will have ongoing health insurance. This trial aims to provide valuable insights into how well the Cordella system works in a real-world setting.

Gender

ALL

Eligibility criteria

• 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)