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

Launched by MEDICAL UNIVERSITY OF WARSAW · Jun 3, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment option called the Coronary Sinus Reducer (CSR) for patients experiencing chest pain, known as angina, but who do not have significant blockages in their coronary arteries. Many of these patients have symptoms caused by issues in the small blood vessels of the heart rather than large artery blockages. The goal of the trial is to see if implanting the CSR can help relieve angina symptoms, improve quality of life, and enhance heart function for these patients.

To participate in this study, patients must have stable angina without significant artery blockages and have already tried maximum medication for at least three months without success. Some key exclusions include recent heart failure hospitalization, severe heart valve disease, and certain heart conditions. Participants will receive the CSR implant and will be closely monitored through tests to assess heart function and quality of life over six months. This study could potentially lead to new guidelines for treating angina in patients without significant coronary artery disease.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Stable angina symptoms without significant obstruction of coronary artery (defined as coronary artery stenosis diameter ≤ 50% or coronary artery stenosis diameter \>50% and ≤70% with FFR\>0.8), with coronary microvascular dysfunction confirmed in invasive test (defined as coronary flow reserve ≤ 2.5 or index of microvascular resistance ≥ 25)
• • No future options for antianginal therapy (maximum antianginal therapy for at least three months)
• Exclusion Criteria:
• • Vasospastic angina (positive test with acetylcholine),
• • Evidence of cardiac ischemia,
• • Coronary flow limiting myocardial bridge,
• • Severe valvular disease
• • Hospitalization for acute heart failure \< 3 months
• • Hypertrophic cardiomyopathy,
• • Ejection fraction ≤ 30%,
• • Permanent pacemaker or defibrillator leads in the right heart,
• • Recent acute coronary syndrome \< 6 months,
• • Recent revascularization \< 2 months,
• • Right atrial pressure of 15 mmHg or higher,
• • Severe renal impairment,
• • Indication for cardiac resynchronization therapy,
• • Pregnancy,
• • Life expectancy of less than 1 year,
• • Inclusion in another clinical trial