Recruiting

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

Sponsor:

Endotronix, Inc.

Code:

NCT06783335

Conditions

Heart Failure NYHA Class III

Heart Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cordella PA Sensor System

Standard of Care Pharmacologic Therapy

Study Details

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.

Conditions

Heart Failure NYHA Class III

Heart Failure

Study ID

NCT06783335

Start date

Feb 7, 2025

Status verified date

Nov, 2025

Completion date

Dec 31, 2030

Anticipated

Primary completion date

Dec 31, 2030

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

2150 participants

Anticipated

Interventions and Outcome Measures

Interventions

Cordella PA Sensor System

Patients who receive the Cordella PA Sensor System for monitoring chronic heart failure
These patients will be monitored for 2 years after receiving the device
Patients must be on guideline-directed medical therapy appropriate for their ejection fraction status

Standard of Care Pharmacologic Therapy

Patients with chronic heart failure who receive standard medical care without PA pressure monitoring
These patients will be monitored for 2 years
Patients must be on guideline-directed medical therapy appropriate for their ejection fraction status

Primary outcome measure

Composite of All-cause Mortality and Heart Failure Hospitalizations [ Time Frame: up to 24 months ]

Central Contacts and Locations

Central contacts

Andrea Sauerland

630-599-7176 andrea_sauerland@edwards.com

Max Gill

max_gill@edwards.com

Locations

Endotronix

Recruiting

Naperville, Illinois, United States, 60563

More Information

Sponsor

Endotronix, Inc.

Last update posted

Nov 19, 2025

Last verified

Nov, 2025

Keywords

Heart failure
Heart Disease
Pulmonary Artery Pressure Sensor
Cardiovascular Disease
Cordella

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Endotronix, Inc. on 2025-11-19.