IRB Study Number 26-259
Status Recruiting
Institute Heart and Vascular Institute
Description
To evaluate the VahatiCor A-FLUX Reducer System® safety and performance in treating patients with symptomatic coronary microvascular dysfunction.
Inclusion Criteria
Older than 18 years of age.
Left ventricular ejection fraction (LVEF) is greater than or equal to 25% within the 12 months before the index procedure.
Willing to comply with the specified follow-up evaluations.
Exclusion Criteria
Significant obstructive epicardial disease (greater than 50% diameter stenosis) that can be treated with PCI or CABG as determined by Investigator and confirmed by the Central Screening Committee.
Recent (less than 30 days before index procedure) troponin or CKMB positive acute coronary syndrome (NSTEMI or STEMI) with evidence of ischemia.
NYHA class IV or decompensated HF or hospitalization due to HF during the 90 days before the index procedure.
