Conformal Medical has announced the launch of the CONFORM pivotal trial with the enrolment of the first patients at two US sites.
The investigational device exemption (IDE) study will evaluate the safety and efficacy of the company’s CLAAS system compared to commercially available LAAO devices to support US Food and Drug Administration (FDA) premarket approval.
The first patients were treated at their respective institutions by co-principal investigators of the trial, Shephal Doshi (Pacific Heart Institute, Santa Monica, USA) and William Gray (Lankenau Institute for Medical Research, Philadelphia, USA).
“I am excited to initiate this important trial and for the potential of this innovative technology to expand treatment options for patients with atrial fibrillation (AF),” stated Gray. “In this study, we will be evaluating the novel foam-based design of the CLAAS implant against the existing FDA-approved devices to evaluate performance on several metrics, including procedural safety, completeness of seal and incidence of device-related thrombus.”
The prospective, multicentre, randomised controlled study will enrol approximately 1,600 patients in the USA, Canada, and Japan. To date, over 75 patients have been successfully implanted with the CLAAS System as part of the company’s early feasibility studies.
“Based on our experience in the Early Feasibility Study, the CLAAS System is highly conformable to accommodate different anatomies,” stated Doshi. “The study is designed to demonstrate the benefits of this technology for both implanting physicians and patients.”
The CLAAS system is designed to seal the LAA in patients with non-valvular AF to reduce the risk of stroke without the need for anticoagulants.