Ceryx Medical has announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Ceryx Medical’s clinical trial authorisation application for the pilot 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 Respiratory Sinus Arrythmia (RSA).

The system has shown a remarkable 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 enroll patients with heart failure with reduced ejection fraction who have undergone a coronary artery by-pass 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 will begin in the UK later this year, recruiting patients from University Hospital Wales, Cardiff; Morriston Hospital, Swansea and the Bristol Heart Institute.

Dr Stuart Plant, Chief Executive Officer, Ceryx Medical said, "We believe Ceryx’s technology can potentially 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, consultant cardiologist at University Hospital Wales and 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."