NCT06783335Recruiting
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
Source: ClinicalTrials.gov · Last updated 19 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 2150 (estimated)
- First submitted
- 14 Jan 2025
- Start date
- 7 Feb 2025
- Primary completion date
- 31 Dec 2030
- Lead sponsor
- Endotronix, Inc.
- Diseases
- Heart failure
- NCT number
- NCT06783335
What you commit to
- Study type: Observational
- Planned participants: 2150
- From 7 Feb 2025 to the primary completion date, 31 Dec 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Receiving palliative care/hospice during baseline period
- Unable to take dual antiplatelet therapy or anticoagulants for one month post implant (Cordella Cohort only)
Other illness
- Record of end-stage renal disease during baseline period
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Endotronix Coordinator of this site? Confirm its status | Naperville | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.