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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 2 years
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official 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)
Study sites (1)
IL
- Endotronix · Naperville, IL 60563More trials in Naperville