The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Ceryx Medical’s clinical trial authorisation application for the pilot respiratory sinus arrhythmia (RSA)-pace study of the Cysoni-XT system for post-cardiac surgery patients.
Cysoni-XT is a temporary cardiac pacemaker which aims to boost cardiac performance by resynchronisation of the heart and lungs, a natural phenomenon known as RSA.
The system has shown an ability to boost performance and induce cardiac repair mechanisms in subjects with heart failure. RSA-pace will be the first time RSA therapy has been evaluated in patients.
The trial will enrol patients with heart failure with reduced ejection fraction (HFrEF) who have undergone a coronary artery bypass (CABG) procedure. The study will evaluate up to 10 days of therapeutic pacing in 32 participants in the UK. The trial’s primary objectives are to assess safety and feasibility, with the aim of evaluating initial efficacy.
The RSA-pace trial is due to begin in the UK later this year, recruiting patients from University Hospital Wales, Cardiff; Morriston Hospital, Swansea and the Bristol Heart Institute.
Ceryx Medical’s chief executive officer, Stuart Plant, said: “We believe Ceryx’s technology has the potential to transform the lives of patients with heart failure. This approval is a significant step on our journey towards a new therapy to support patients in their recovery and boost cardiac performance.”
Zaheer Yousef, a consultant cardiologist at University Hospital Wales (Cardiff, UK) and principal investigator (PI) for the study, said: “Patients with heart failure are at an increased risk of prolonged cardiac dysfunction following cardiac surgery. I am excited by the potential benefits of RSA pacing in post-surgical patients.”
