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Real World Effectiveness of the Cordella Pulmonary Artery Sensor System in Patients With Chronic Heart Failure

This study is looking at how well the Cordella PA Sensor System works for people with chronic heart failure (a condition where your heart can't pump enough blood). It compares patients who use the Cordella system, which monitors heart pressure from home, to those who receive standard medical care without this device. To join the Cordella group, you would have received the device between October 2024 and December 2029, have chronic heart failure with NYHA Class III symptoms (meaning you have significant limitations with physical activity), and be on standard heart failure medications. The study will track patients for two years to see if using the Cordella system leads to fewer deaths and hospital stays related to heart failure. The current status of this study is unclear.

Study design
This is an observational study, meaning researchers will look at existing medical data rather than assigning treatments. It plans to include 2150 participants.
What's involved
Patients in both groups will be monitored for 2 years. The study uses real-world data, so specific visits or procedures beyond routine care are not detailed.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for up to 24 months to track outcomes like death and heart failure hospitalizations.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06783335

Real World Effectiveness of the Cordella Pulmonary Artery Sensor System in Patients With Chronic Heart Heart Failure

Recruiting
Not specifiedAges 18+Observational
Endotronix, Inc.
~2,150 participants
Updated 2025-11-19 on ClinicalTrials.gov
What's tested:Cordella PA Sensor SystemStandard of Care Pharmacologic Therapy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Composite of All-cause Mortality and Heart Failure Hospitalizations
Measured over up to 24 months

Conditions

Heart Failure NYHA Class III
Heart Failure

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Heart Failure

NCT06783335

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Endotronix

    Naperville, Illinoisno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Joanna VanHouten, PhD · PRINCIPAL_INVESTIGATOR · Endotronix, Inc.

Who to contact

Andrea Sauerland
[email protected]
630-599-7176
Email the study team

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Eligibility criteria

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

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)

What this trial measures

  • Composite of All-cause Mortality and Heart Failure Hospitalizationsup to 24 months

    * Description: The cumulative number of all-cause deaths and heart failure hospitalizations * Time Frame: 2 years after study entry (time zero) * Statistical Analysis Plan: The primary analysis will use an Andersen-Gill recurrent event model to account for multiple hospitalizations within individuals * Primary outcome will be assessed in the overall population