Coronary Sinus Reducer Therapy for Persisting Angina

Exclusion Criteria

• •Age \< 18 years.
• •Absence of symptoms reported on the ORBITA-app during the 2-week screening period.
• •Mean right atrial pressure ≥15 mmHg
• •Severe pulmonary hypertension.
• •Coronary sinus anatomy not suitable for CSR implantation.
• •Pregnancy or planned pregnancy within the next 12 months.
• •Recent acute coronary syndrome (within 3 months).
• •Recent revascularization with PCI (within 6 months).
• •Severe arrhythmias, including chronic atrial fibrillation with persistent rapid ventricular response (\>100bpm despite medication).
• •Indication for cardiac resynchronization therapy.
• •Severe left ventricular impairment (left ventricular ejection fraction \<30%).
• •NYHA class IV or decompensated heart failure or hospitalization due to heart failure within 90 days before the index procedure.
• •Recent implantation of a permanent pacemaker or defibrillator lead in the right ventricle or atrium (within 90 days before the index procedure).
• •Presence of a pacemaker lead in the coronary sinus.
• •Severe valvular heart disease.
• •History of tricuspid valve replacement or repair.
• •Kidney failure (estimated glomerular filtration rate \<30ml/min)
• •Contra-indication to short term dual antiplatelet therapy or lifelong aspirin treatment.
• •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.
• •Unable or unwilling to use the ORBITA app
• •Known inability to tolerate contrast medium.
• •Life expectancy \<1 year.