NCT04089059

PROACTIVE-HF IDE Trial Heart Failure NYHA Class III

A Prospective, Multi-Center, Open Label, Single Arm Clinical Trial Evaluating the Safety and Efficacy of the Cordella™ Pulmonary Artery Sensor System in NYHA Class III Heart Failure Patients (PROACTIVE- HF Trial)

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 738 (actual)
• Sponsor: Endotronix, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, open- label, single arm, multicenter clinical trial to evaluate the safety and effectiveness of the Cordella PA Sensor System in NYHA Class III Heart Failure Patients compared to a Performance Goal (PG).

Conditions

• Heart Failure NYHA Class III

Interventions

Type	Name	Description
DEVICE	Cordella™ Pulmonary Artery Sensor System	The Cordella PA Sensor System (CorPASS) is intended to measure, record, and transmit pulmonary artery pressure (PAP) data from NYHA Class III heart failure patients at home to clinicians for assessment and patient-centered heart failure management and comprises of seven subsystems that operate together to take daily Pulmonary Artery Pressure (PAP) readings at a patient's home and transmit the results to a care provider for evaluation. 1. Cordella Sensor 2. Cordella Delivery System 3. myCordella Patient Reader 4. Reader Dock 5. Cordella Calibration Equipment (CalEQ) 6. myCordella Hub 7. Cordella Data Analysis Platform (CDAP)

Timeline

• Start date: 2020-01-10
• Primary completion: 2028-04-01
• Completion: 2028-04-01
• First posted: 2019-09-13
• Last updated: 2025-03-03
• Results posted: 2025-03-03

Locations

74 sites across 3 countries: United States, Belgium, Ireland

Regulatory

• FDA-regulated device study