VahatiCor's Coronary Sinus Reducer (A-FLUX) has been designed to improve angina or angina-like symptoms in patients with CMD. SERRA-I is an early feasibility study that evaluates the safety and clinical performance of the A-FLUX Reducer in this population.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
The VahatiCor A-FLUX Reducer System is an implantable, self-expanding dense-cell nitinol coronary sinus flow restrictor device pre-loaded into the A-FLUX Delivery Catheter.
University Medical Center Utrecht
Utrecht, Netherlands
RECRUITINGUniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu
Warsaw, Poland
RECRUITINGProcedural Success
Successful delivery and deployment of VahatiCor A-FLUX Reducer System
Time frame: Throughout the study, up to 12 months post-procedure
Safety: Rate of device- and procedure- related SAEs
Rate of device- and procedure-related SAEs.
Time frame: 30-days post-procedure
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