Coronary Sinus Reducer in Patients With Angina With no Obstructive Coronary Disease: a Prospective Single-arm Study

What this Trial Is About

Researchers are investigating the use of the Coronary Sinus Reducer (CSR) device in patients who have angina symptoms but no significant blockage in their coronary arteries, a condition known as ANOCA (Angina with No Obstructive Coronary Artery Disease). This condition can involve coronary microvascular dysfunction (CMD), which is challenging to treat with drugs due to multiple underlying causes. The study also considers the frequent coexistence of heart failure with preserved ejection fraction (HFpEF) in these patients, a condition linked to worse outcomes and associated with CMD. The aim is to evaluate CSR's potential to improve angina symptoms, quality of life, and heart function. In this prospective, single-arm study, patients will receive implantation of the Neovasc CSR device, which narrows the coronary sinus to increase pressure and improve blood flow in heart muscle microcirculation. The procedure includes periprocedural testing of coronary microcirculation before and immediately after implantation. Follow-up assessments will be performed six months later. The CSR device is the only treatment evaluated in this study. Participants will undergo baseline and six-month echocardiography analyzed by an external core lab, exercise testing using a six-minute walk test, and quality of life questionnaires (SF-36). Angina severity will be tracked using the Seattle Angina Questionnaire, a dedicated app, and Canadian Cardiovascular Society grading. Researchers will measure changes in angina symptoms, heart muscle function, microvascular resistance, and exercise capacity to understand the device's effects and safety over the study period.

Coronary Sinus Reducer in Patients With Angina With no Obstructive Coronary Disease