Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2025-12-24 @ 10:10 PM
NCT ID:
NCT06783335
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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06783335
Study Brief:
Protocol Section:
NCT06783335