Treatment of Severe Refractory Angina with the Neovasc Coronary Sinus Reducer for Patients Not Eligible for Revascularization

What this Trial Is About

This research aims to evaluate the use of the Neovasc Coronary Sinus Reducer device in patients suffering from refractory angina who have advanced obstructive coronary artery disease and severe symptoms despite optimal medical treatment. These patients are not candidates for surgical or percutaneous revascularization. The study focuses on those with reversible ischemia and aims to reduce angina episodes and improve quality of life in this difficult-to-treat population. Participants will receive the Neovasc coronary sinus reducer device through an open-label procedure. This device is implanted in the coronary sinus and has been previously used in a limited number of patients with promising safety data up to three years. The procedure carries theoretical risks similar to pacemaker electrode insertion but has not shown procedure-related adverse events in prior studies. The goal is to reduce angina severity, improve heart function, and decrease reliance on medications and healthcare visits. During the study, participants will be monitored for changes in their angina severity using the Canadian Cardiovascular Society Angina Score over six months. Researchers will assess symptoms, quality of life, and heart function improvements. The study includes detailed follow-up visits and evaluations to track safety and effectiveness of the device. Total participation duration and ongoing monitoring details are determined by the study protocol.

Use of the Neovasc Coronary Sinus Reducer System for the Treatment of Refractory Angina Pectoris in Patients With Ngina Class 3-4 Who Are Not Candidates for Revascularization