The prospective and multi-centre Sirona 11 study has been designed to assess the safety and efficacy of the Cordell Sensor in support of the company’s CE mark submission.
Cardiologist Prof. Dr. Wilfried Mullens recruited the first patient in the trail patient at the Hospital Oost-Limburg in Genk, Belgium.
Dr. Mullens, an investigator in the Sirona I First-in-Human study, said: “The current treatment model for chronic heart failure is reactive and costly. Clinical data demonstrates that pulmonary artery (PA) pressure is the best indicator for early detection and proactive care of heart failure decompensation.”
The open-label Sirona CE mark trial will enroll patients at up to eight European sites to demonstrate the safety and efficacy of the Cordella Sensor for the management of New York Heart Association (NYHA) Class III heart failure patients.
Major secondary endpoints of the trial comprise of heart failure hospitalisations, device performance, and patient quality of life.
Cordella Sensor is an integrated component of the comprehensive Cordella heart failure system (Cordella System). The system is also comprised of a remote patient management platform with tools to collect and share daily patient data with healthcare providers.
Both the Cordella system and Sensor intend to proactively deliver healthcare providers with the required information to enhance patient care between office visits and support reimbursement for care delivery activities.
The system allows remote titration of medication, as well as streamlines patient management to make patients out of the hospital.
Cordella Sensor, which is an investigational device, is not yet commercially available for use in any geography. Cordella System, without the sensor, is commercially marketed in the US and EU.
Endotronix chief medical officer Dr Katrin Leadley said: “SIRONA II builds on the success of our First-in-Human trial and expands our experience with the Cordella Sensor as we progress towards receiving our CE Mark.
“It is the next step in our robust clinical program, which also includes a pivotal IDE trial for the implantable sensor, PROACTIVE-HF, set to begin later this year in the U.S.”
