Cordella™ Sensor System for Heart Failure
(PROACTIVE-HF Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing a device called the Cordella PA Sensor System, which monitors heart pressure. It is aimed at patients with moderate to severe heart failure who need better treatment options. The device helps doctors track heart function and adjust treatments accordingly. The Cordella PA Sensor System is a novel device for continuous monitoring of heart pressure, similar to the previously approved CardioMEMS device.
Will I have to stop taking my current medications?
The trial requires participants to be on stable, optimally titrated heart failure medication for at least 30 days before joining. This means you should continue your current medications as prescribed.
Is the Cordella Sensor System safe for use in humans?
How is the Cordella™ Sensor System treatment different from other heart failure treatments?
What data supports the effectiveness of the Cordella™ Sensor System for Heart Failure treatment?
Who Is on the Research Team?
Andrea Sauerland
Principal Investigator
Endotronix, Inc.
Are You a Good Fit for This Trial?
This trial is for adults with NYHA Class III Heart Failure who've been on stable heart failure therapy for at least 30 days and have had a recent hospital visit or high NT-proBNP levels. They must be able to use the myCordella™ Patient Reader device daily, have good internet at home, and commit to follow-up visits. Excluded are those with severe kidney issues, non-compliance history, certain cardiovascular events within 3 months, specific intolerances or allergies, active infections, pregnancy/breastfeeding, or other life-limiting severe illnesses.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the Cordella PA Sensor System for heart failure management, with daily monitoring of pulmonary artery pressure and vital signs
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of heart failure hospitalizations and mortality
Extension
Participants may continue to be monitored for long-term outcomes such as heart failure hospitalizations and mortality
What Are the Treatments Tested in This Trial?
Interventions
- Cordella™ Pulmonary Artery Sensor System
Cordella™ Pulmonary Artery Sensor System is already approved in United States, European Union for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Endotronix, Inc.
Lead Sponsor