Study of the Colibri Transcatheter Aortic Heart Valve System for Treating Severe Aortic Stenosis in High-Risk Patients Aged 75 and Older

What this Trial Is About

Researchers are evaluating the Colibri Transcatheter Aortic Heart Valve System in patients aged over 75 years who have symptomatic severe aortic stenosis and are at high surgical risk. This prospective, single-arm clinical investigation will be conducted at about seven European sites to assess the safety and performance of this heart valve system compared to recent historical results. The primary focus is on the rate of all-cause mortality at 30 days post-implantation, with additional evaluations up to five years after the procedure. Participants will receive the Colibri heart valve implanted via transfemoral access. This treatment is intended for patients with severe aortic tricuspid valve stenosis who meet specific anatomical and clinical criteria, such as heart valve measurements and surgical risk assessments. The study involves a single treatment group receiving the investigational device, with follow-up visits scheduled at 30 days, 6 months, 12 months, and annually up to five years to monitor the devices performance and safety. During the study, participants will undergo assessments including ECG-gated Multi-Slice Computed Tomography MSCT for valve measurements and clinical evaluations by the Heart Team and a Centralized Case Review Committee. Researchers will track mortality and adverse events, along with heart function and symptom status. Participants are expected to provide informed consent and agree to scheduled follow-ups to help researchers understand the devices long-term impact on patient health and safety.

Colibri Transcatheter Aortic Heart Valve System Study