NCT03375710

SIRONA Trial Heart Failure NYHA Class III

A Prospective, Multi-Center, Open-Label, Single-Arm Clinical Trial Evaluating the Safety and Efficacy of the Cordella™ Heart Failure System in (New York Heart Association) NYHA Class III Heart Failure Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (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 feasibility trial to assess device safety and efficacy of the Cordella™ Heart Failure System in 10 NYHA Class III heart failure patients who will receive the Cordella™ Sensor implant.

Detailed description

The objectives of this study are to establish that the Cordella™ Sensor can be safely delivered, deployed, and remain stable within the target pulmonary artery (PA) segment through 30 days post-implant as well as to measure the accuracy of Cordella™ Sensor PA pressure measurements compared with fluid-filled catheter PA pressure measurements obtained by standard right heart catheterization (RHC) at 90 days post implant. Safety measures will include the frequency and rates of adverse events, both overall and for each specific event, which will be collected throughout the study. Subjects will remain in this trial for 24 months.

Conditions

• Heart Failure NYHA Class III

Interventions

Type	Name	Description
DEVICE	Cordella™ Heart Failure System	The Cordella™ Heart Failure System collects, records, and transmits physiologic data and communications from the patient at home to clinicians for assessment, patient communication, and patient-centered heart failure management. The system consists of the following components: 1. myCordella™ Patient Management Portal 2. myCordella™ Hub 3. myCordella™ Peripherals, including the Cordella™ Pulmonary Artery Sensor System (CorPASS)

Timeline

• Start date: 2017-12-01
• Primary completion: 2019-05-28
• Completion: 2025-08-26
• First posted: 2017-12-18
• Last updated: 2025-09-02

Locations

2 sites across 2 countries: Belgium, Ireland