SIRONA 2 Trial
Research type
Research Study
Full title
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)
IRAS ID
258893
Contact name
Alexander Rothman
Contact email
Sponsor organisation
Endotronix, Ireland Limited
ISRCTN Number
ISRCTN00000000
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 6 months, 0 days
Research summary
Heart failure (HF) is a major public health problem that affects over 23 million people worldwide with approximately 2 million new cases diagnosed each year. HF is a complex clinical syndrome in which the ventricle’s ability to fill or eject blood is impaired, affecting delivery of oxygen and nutrient-rich blood throughout the body. The body’s compensation mechanisms in the presence of heart failure include enlargement of the heart, a faster heart rate (HR), narrowing of blood vessels to maintain blood pressure (BP), and diversion of blood away from other vital tissues and organs. While these compensation mechanisms may decrease heart failure symptoms, their effects are only temporary and eventually, the heart fails to keep up with the body’s demands. Heart failure is chronic, worsens over time, and is characterised by acute exacerbations (an increase in the severity of a disease or its signs and symptoms). These periodic exacerbations require treatment intensification most often in the hospital setting and are the single most frequent cause of hospitalisation in persons aged ≥65 years.
After the diagnosis of HF, survival estimates are 50% and 10% at 5 and 10 years, respectively, and left ventricular dysfunction is associated with an increase in the risk of sudden death. There is no cure for HF, but treatment plan options consist of lifestyle changes, medications, implantable cardiac devices, and surgical procedures including heart transplants. Treatment goals for HF include targeting the underlying cause of the condition, reducing clinical symptoms and improving the patient’s quality of life, and preserving heart function.
HF is associated with significant mortality, morbidity, and healthcare expenditures affecting patients, their families, care providers, and payers. The incidence of HF is on the rise and healthcare systems are grappling with the persistent burden of HF. Nearly 1 million hospitalisations for HF occur each year, and readmission rates are frequent. Entire economic systems are impacted due to the aging global population, high cost of care, and limitations of existing solutions for HF.
The main aim of the study is to obtain real-time accurate Pulmonary Artery Pressure (PAP) when activated and implanted in participants and to evaluate the safety and effectiveness of the Cordella PA Sensor System. Also the study will evaluate the frequency of adverse events throughout the study, device/system-related complications and pressure sensor failure rate throughout the study. This study will be performed at approximately 10 study centres in Europe and the study will enrol 50 male and female participants aged above 18 years who are suffering from the condition of moderate to advanced heart failure. Once selected for the study Cordella PA Sensor System will be implanted surgically in participants. Participants will be in the study for approximately 24 months (2 years).
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
19/YH/0047
Date of REC Opinion
31 May 2019
REC opinion
Further Information Favourable Opinion