Summary
The PROACTIVE-HF-2 Trial is a research study looking at a small device called the Cordella™ Pulmonary Artery Sensor. Doctors use this sensor to check how your heart is working by measuring the pressure in your lungs every day. The goal of the study is to help people with heart failure feel better and stay out of the hospital.
Description
This is a prospective, multi-center, open label, randomized control clinical trial evaluating the safety and efficacy of the Cordella™ Pulmonary Artery Sensor System in NYHA Class II-III Heart Failure Patients (PROACTIVE-HF-2 Trial).
The study contains of 5 arms:
NYHA II Cohort - To demonstrate safety and efficacy of the Cordella PA Sensor System in NYHA Class II HF patients, where patients have daily access to PAP data.
- Treatment Arm (Group 1)
- Active Control Arm (Group 2)
- Crossover Arm (Group 3)
NYHA III Cohort - To demonstrate safety and efficacy of the Cordella PA Sensor System in NYHA Class III HF patients, where patients have daily access to PAP data, including a randomized sub-study to evaluate a clinician-directed patient self-management strategy.
Principal Investigator
Study Coordinator
Faculty Contact
Kristi Sutphin - kristi.sutphin@vandaliahealth.org