StudyFinder
A Prospective, Multi-Center, Open Label, Randomized Control Clinical Trial Evaluating the Safety and Efficacy of the Cordella™ Pulmonary Artery Sensor System in New York Heart Association (NYHA) Class II Heart Failure Patients (PROACTIVE- HF-2 Trial)
Recruiting
The Cordella™ Pulmonary Artery Sensor System is a possible treatment for New York Heart Association (NYHA) Class II and III heart failure. The main purpose of this study is to investigate the safety and effectiveness of the study device in helping to reduce Heart Failure hospitalizations.
Male or Female
18 years and over
Inclusion Criteria:
• Heart Failure NYHA Class II or Class III
Exclusion Criteria:
• ACC/AHA Stage D refractory Heart Failure (HF)
• history of multiple pulmonary embolism (PE)
• resting systolic blood pressure less than 90 mmHg
Device: Cordella™ Pulmonary Artery Sensor System
Heart & Vascular
Cardiovascular, Clinics and Surgery Center (CSC), Heart Failure, HF