RSA-pace will be the first time RSA therapy has been evaluated in patients. 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.
- The trial will enrol 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.