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

NCT06783335 | Recruiting FDA Device

• 1 other identifier: OS-2025-001
• Study Type: observational
• Target: 2,150
• Locations: 1 country
• Sites: 1

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

Keywords

Heart failure; Heart Disease; Pulmonary Artery Pressure Sensor; Cardiovascular Disease; Cordella

Outcome Measures

Primary Outcomes (1)

• Composite of All-cause Mortality and Heart Failure Hospitalizations

  * 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

  up to 24 months

Secondary Outcomes (5)

• Composite Outcome in Racial and Ethnic Subgroups

  up to 24 months

• Composite Outcome in Patients with Chronic Kidney Disease

  up to 24 months

• Composite Outcome in Patients with Cardiac Devices

  up to 24 months

• Composite Outcome in Patients by Ejection Fraction

  up to 24 months

• Composite Outcome in Patients Age 75+

  up to 24 months

Interventions

Cordella PA Sensor System DEVICE

* 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 DRUG

* 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with NYHA III chronic HF

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Endotronix, Inc.: lead

Study Sites (1)

Endotronix

Naperville, Illinois, 60563, United States

RECRUITING

MeSH Terms

Conditions

Heart Failure; Heart Diseases; Cardiovascular Diseases

Study Officials

• Joanna VanHouten, PhD

  Endotronix, Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Sauerland

CONTACT

630-599-7176; andrea_sauerland@edwards.com

Max Gill

CONTACT

max_gill@edwards.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2025
• First Posted: January 20, 2025
• Study Start: February 7, 2025
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)