Coronary Sinus Reducer in Coronary Microvascular Disease

Launched by UMC UTRECHT · Mar 26, 2025

Keywords

ClinConnect Summary

The clinical trial titled "Coronary Sinus Reducer in Coronary Microvascular Disease" is investigating a new treatment option for patients who experience ongoing chest pain, known as angina, due to coronary microvascular dysfunction (CMD). CMD is a condition where the small blood vessels in the heart do not function properly, leading to treatment-resistant angina. In this study, a special device called the coronary sinus reducer (CSR) will be tested to see if it can improve blood flow in the heart and reduce the number of angina episodes. The trial will include 50 participants who will be randomly assigned to receive either the CSR or a placebo (a treatment with no active ingredient) for comparison.

To be eligible for this trial, participants must be adults diagnosed with CMD, have specific measures indicating poor blood flow, and still experience angina despite taking maximum medical therapy. Key exclusions include individuals under 40 years old, those with severe heart conditions, or recent heart events like heart attacks. Participants will undergo assessments over six months to track any changes in their heart function and the frequency of angina episodes. The trial is not yet recruiting participants, but it aims to provide valuable insights into new treatment options for those suffering from CMD.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Coronary microvascular dysfunction as expressed by abnormal absolute coronary flow reserve (CFR\<2.5) confirmed during the index study procedure using the continuous thermodilution technique and saline-induced coronary hyperemia.
• • 2. No hemodynamically significant epicardial stenoses based on both non-hyperemic pressure ratio (NHPR; iFR\&gt;0.89, or RFR\&gt;0.89, or dFR\&gt;0.89) and fractional flow reserve (FFR\&gt;0.80) assessments.
• • 3. Angina - Canadian Cardiovascular Society Class II-IV on maximal medical therapy.
• • 4. Negative acetylcholine provocation testing with respect to epicardial or microvascular vasospasm (as such, patients with equivocal acetylcholine provocation test results are not eligible for enrolment).
• • 5. Patient understands the nature of the procedure and provides written informed consent prior to enrolment.
• • 6. Patient is willing to comply with specified follow-up evaluation.
• Exclusion Criteria:
• • 1. Age ≤ 40 years.
• • 2. Pregnancy.
• • 3. Recent acute coronary syndrome (within 3 months).
• • 4. Recent revascularization with PCI (within 6 months).
• • 5. Severe arrhythmias, including chronic atrial fibrillation.
• • 6. Severe left ventricular impairment (left ventricular ejection fraction \&lt;25%).
• • 7. Permanent pacemaker or defibrillator leads in the right ventricle or atrium.
• • 8. Indication for cardiac resynchronization therapy.
• • 9. Severe valvular heart disease.
• • 10. History of tricuspid valve replacement or repair.
• • 11. Mean right atrial pressure ≥15 mm Hg.
• • 12. Known allergy to stainless steel or nickel.
• • 13. Anomalous or abnormal CS anatomy (e.g., tortuosity, aberrant branch, persistent left superior vena cava).
• • 14. CS diameter at the site of planned implantation greater than 13mm or less than 9.5mm as measured on the venogram.
• • 15. Currently enrolled in another investigational device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints.
• • 16. Life expectancy \<1 year.