Evaluation of the A-FLUX Self-Expanding Coronary Sinus Reducer Device for Adults with Symptoms of Coronary Microvascular Dysfunction

What this Trial Is About

Researchers are evaluating the VahatiCor A-FLUX Self-Expanding Coronary Sinus Reducer device for adults with symptomatic coronary microvascular dysfunction CMD, a condition causing angina or angina-like symptoms. This early feasibility study aims to assess the safety and clinical performance of the A-FLUX Reducer in improving these symptoms in patients who continue to experience angina despite optimal medical therapy. Participants will receive the A-FLUX Reducer System, an implantable self-expanding device made of dense-cell nitinol and delivered via a catheter into the coronary sinus. The device is designed to restrict coronary sinus flow. The study follows a single group design where all participants undergo the implantation procedure, with eligibility confirmed before implantation based on specific heart function and anatomy criteria. During the study, participants will be monitored for procedural success and safety outcomes up to 12 months after implantation, including the rate of device- and procedure-related serious adverse events within 30 days post-procedure. Follow-up evaluations will include assessments of heart function and symptom tracking. Participants will be asked to comply with these evaluations and provide informed consent before joining the study.

Self Expanding Coronary Sinus Reducer for Treatment of Symptomatic Coronary Microvascular Dysfunction (CMD)