NCT04012944

SIRONA 2 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 New York Heart Association (NYHA) Class III Heart Failure Patients (SIRONA 2 Trial)

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: Endotronix, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, multi-center, open-label, single-arm CE-Mark trial to assess device safety and efficacy of the Cordella PA Sensor System in up to 75 New York Heart Association (NYHA) Class III Heart Failure patients who will receive the Cordella PA Sensor Implant.

Detailed description

The study objectives are: 1. To establish that the Cordella PA Sensor can be safely delivered, deployed, and remain stable within the target pulmonary artery (PA) segment through 30 days post-implant. 2. To compare Cordella PA Sensor System pressure measurements with fluid-filled catheter PA pressure measurements obtained by standard right heart catheterization (RHC) at 90 days post implant.

Conditions

• Heart Failure NYHA Class III

Interventions

Type	Name	Description
DEVICE	Cordella™ Pulmonary Artery Sensor System	The Cordella PA Sensor System comprises 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: 2019-06-26
• Primary completion: 2021-10-30
• Completion: 2027-07-01
• First posted: 2019-07-09
• Last updated: 2025-08-07

Locations

7 sites across 3 countries: Belgium, Germany, Ireland