Heart Failure Clinical Trials

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The Real-World Effectiveness of The Cordella Pulmonary Artery Sensor System in Patients With Chronic Heart Failure: A Comparative Analysis to Standard of Care Pharmacologic Therapy

Status: Recruiting
Location: See location...
Intervention Type: Device, Drug
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Illinois
Endotronix
RECRUITING
Naperville
Contact Information
Primary
Andrea Sauerland
andrea_sauerland@edwards.com
630-599-7176
Backup
Max Gill
max_gill@edwards.com
Time Frame
Start Date: 2025-02-07
Estimated Completion Date: 2030-12-31
Participants
Target number of participants: 2150
Related Therapeutic Areas
Sponsors
Leads: Endotronix, Inc.

This content was sourced from clinicaltrials.gov