Studies a heart sensor device for people with chronic heart failure
Compares a pulmonary artery sensor with standard medicines in adults with heart failure.
Plain-language title generated from the registry record
Registry title: Real World Effectiveness of the Cordella Pulmonary Artery Sensor System in Patients With Chronic Heart Heart Failure
Key facts
- Where
- Naperville, United StatesSee the site
Where in United States
- EndotronixNaperville, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Endotronix, Inc.
- Trial code
- NCT06783335
- Record updated
- 19 November 2025
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: Receiving palliative care/hospice during baseline period; Unable to take dual antiplatelet therapy or anticoagulants for one month post implant (Cordella Cohort only); Record of end-stage renal disease during baseline period; 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.