Coronary Sinus Reducer Implantation in Patients With Ischaemia and Non-obstructed Coronary Arteries and Coronary Microvascular Dysfunction.

Launched by IMPERIAL COLLEGE LONDON · Aug 5, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment option called the Coronary Sinus Reducer for patients suffering from ongoing chest pain, known as angina, caused by poor blood flow in the heart despite having no blockages in their major coronary arteries. The goal is to see if this device can help improve heart function and relieve symptoms for patients with conditions like microvascular angina, where the small blood vessels in the heart do not work properly.

To join the study, participants must be over 18 years old and have experienced symptoms of angina for at least three months, even after trying other heart medications. They should have heart arteries that show minimal blockage during tests and agree to stay on their current medication regimen throughout the trial. Participants will receive the treatment and undergo follow-up evaluations to monitor their heart health. It's important to note that there are specific health conditions that may disqualify someone from joining, such as having a significant blockage in the heart arteries or certain heart diseases. This study is currently recruiting participants, and those interested will need to provide informed consent and be available for the duration of the trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age \>18 years
• • 2. Ongoing symptomatic angina, CCS Class II-IV, for ≥3 months despite background treatment with at least two anti-anginal drug at the maximal tolerated dose.
• • 3. Patients willing to consider no change in anti-anginal drug treatment for the duration of their participation in the trial.
• • 4. Unobstructed coronary arteries with ≤50% epicardial stenoses demonstrated on coronary angiography.
• • 5. Stress-induced hypoperfusion on CMR (Global MPR ≤ 2.2).
• • 6. Willingness to comply with the specified follow-up evaluation and to be contactable during the period of the trial.
• • 7. Understands the nature of the trial procedures and provides written informed consent.
• Exclusion Criteria:
• • 1. Epicardial CAD in a main coronary artery (stenoses \>50%, RFR≤0.92 or FFR≤0.80), coronary artery bypass grafting, or myocardial infarction (MI).
• • 2. Previous PCI within 6 months
• • 3. PCI with stent insertion for acute MI or chronic total occlusion (CTO)
• • 4. Abnormal coronary sinus anatomy (tortuosity, aberrant branch, persistent left superior vena cava)
• • 5. Coronary sinus diameter at site of implant \<9.5mm or \>13mm
• • 6. Mean right atrial pressure \<15mmHg at time of implantation
• • 7. Any structural heart disease including left ventricular hypertrophy; cardiomyopathy; severe valvular heart disease; previous valve replacement; myocardial bridge on angiography; LVEF\<45% by CMR.
• • 8. Clinically or angiographically diagnosed coronary vasospasm
• • 9. Previous hospitalisation for decompensated heart failure
• • 10. Pacemaker or defibrillator electrode in the right atrium, right ventricle or coronary sinus
• • 11. Documented arrhythmia requiring planned implantation of a permanent pacemaker or defibrillator
• • 12. Chronic kidney disease (creatinine \>200 micromol/L; established on renal replacement therapy; functioning renal transplant)
• • 13. Haemoglobin \<80g/L
• • 14. Contraindications to receiving dual antiplatelet therapy
• • 15. Severe chronic obstructive pulmonary disease (FEV1 \<55% predicted)
• • 16. Moribund patients with life expectancy \< 1year
• • 17. Known allergy to nickel or steel
• • 18. Current enrolment in another investigational device or drug trial
• • 19. Contraindications to CMR or receiving intravenous adenosine
• • 20. Pregnancy