Study of the Self-Expanding A-FLUX Coronary Sinus Reducer Device to Treat Symptomatic Coronary Microvascular Dysfunction in Adults

What this Trial Is About

Researchers are evaluating the safety and clinical performance of the VahatiCor A-FLUX Coronary Sinus Reducer in patients with symptomatic Coronary Microvascular Dysfunction CMD. This early feasibility study focuses on patients who experience angina or angina-like symptoms despite optimal medical therapy. The study aims to assess how well this new device works and its safety in this specific population. The intervention involves implanting the A-FLUX Reducer System, a self-expanding dense-cell nitinol device designed to restrict flow in the coronary sinus. This device is pre-loaded into a delivery catheter for implantation. The study monitors the procedural success and safety of the device, particularly looking for any serious adverse events related to the device or procedure within 30 days and up to 12 months post-implantation. Participants will undergo implantation of the device and be followed for up to 12 months after the procedure. Researchers will assess procedural success and monitor for safety events. Evaluations include tracking angina symptoms and clinical outcomes over time. Participants must comply with follow-up visits and assessments as specified by the study protocol to help determine the devices performance and safety in managing CMD symptoms.

Self-Expanding Coronary Sinus Reducer for Treatment of Symptomatic Coronary Microvascular Dysfunction (CMD) (SERRA-I Study)