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