NCT06783335 Real World Effectiveness of the Cordella Pulmonary Artery Sensor System in Patients With Chronic Heart Heart Failure
| NCT ID | NCT06783335 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Endotronix, Inc. |
| Condition | Heart Failure NYHA Class III |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,150 participants |
| Start Date | 2025-02-07 |
| Primary Completion | 2030-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,150 participants in total. It began in 2025-02-07 with a primary completion date of 2030-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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)
Contact & Investigator
Joanna VanHouten, PhD
PRINCIPAL INVESTIGATOR
Endotronix, Inc.
Frequently Asked Questions
Who can join the NCT06783335 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Heart Failure NYHA Class III. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06783335 currently recruiting?
Yes, NCT06783335 is actively recruiting participants. Contact the research team at andrea_sauerland@edwards.com for enrollment information.
Where is the NCT06783335 trial being conducted?
This trial is being conducted at Naperville, United States.
Who is sponsoring the NCT06783335 clinical trial?
NCT06783335 is sponsored by Endotronix, Inc.. The principal investigator is Joanna VanHouten, PhD at Endotronix, Inc.. The trial plans to enroll 2,150 participants.
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