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

Part of paid clinical trials in Naperville, Illinois.

Sponsor
Endotronix, Inc.
Study ID
NCT06783335
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

Start date
Feb 7, 2025
Status verified
Nov 2025
Primary completion
Dec 31, 2030
Completion
Dec 31, 2030

Study Design

Enrollment
2,150 participants (estimated)

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
EndotronixNapervilleIllinois60563-

Find similar trials in Naperville, IL

By condition
Heart failure
By specialty
CardiologyHeart disease
By research site
Endotronix· Naperville, IL

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