Safety and Efficacy of the Cordella™ Pulmonary Artery Sensor System
Research type
Research Study
Full title
A Prospective, Multi-Center, Open Label, Randomized Control Clinical Trial Evaluating the Safety and Efficacy of the Cordella™ Pulmonary Artery Sensor System in New York Heart Association (NYHA) Class II - III Heart Failure Patients (PROACTIVE-HF-2 Trial).
IRAS ID
358689
Contact name
Alexander Rothman
Contact email
Sponsor organisation
Endotronix, Ireland Limited
Clinicaltrials.gov Identifier
Duration of Study in the UK
6 years, 1 months, 14 days
Research summary
Heart failure is a serious condition where the heart doesn't pump blood to the body effectively, causing symptoms like breathlessness, fatigue, and ankle swelling. People with heart failure are frequently hospitalized or need emergency treatment when fluid builds up, in their lungs or lower legs, a problem called congestion. Currently, doctors often don't know about this fluid buildup until patients develop
symptoms and need to come to hospital.This study aims to find out whether a new monitoring system called the Cordella™ Pulmonary Artery Sensor System can help doctors manage heart failure more effectively. The sensor measures pressure in the pulmonary artery (the blood vessel connecting the heart to the lungs), which can detect fluid buildup before patients feel unwell. By catching problems early, doctors may be able to adjust medications and prevent hospital admissions.
Approximately 1,650 adult patients with moderate to severe heart failure will participate across multiple hospitals in the USA and Europe. All participants will have a small wireless sensor implanted in their pulmonary artery during a brief procedure. Patients will then use a handheld reader at home to take daily measurements of their pulmonary artery pressure, along with weight, blood pressure, heart rate, and oxygen levels. A tablet captures this information, that then is sent to their medical team.
The study has different groups: some patients can see their pressure readings alongside their doctors, others will be partially blinded, while followed up for 24 months to compare hospital admissions and health outcomes between the different approaches. A group of participants will be allowed to self-manage part of their heart failure medication (“water pills”) to evaluate self-management, similar to blood sugar management in a diabetes patient.
If successful, this system could help reduce hospital admissions, improve quality of life, and allow patients to manage their condition more independently at home with better support from their healthcare team.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
25/YH/0209
Date of REC Opinion
19 Jan 2026
REC opinion
Further Information Favourable Opinion