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.
Yale University
New Haven, Connecticut, United States
RECRUITINGThe Lindner Research Center at The Christ Hospital
Cincinnati, Ohio, United States
RECRUITINGThe Cleveland Clinic Foundation
Cleveland, Ohio, United States
RECRUITINGProcedural Success
Successful delivery and deployment of VahatiCor A-FLUX Reducer System to the intended site and Delivery Catheter retrieval without device-and procedure-related SAEs. SAEs include cardiac death, CS perforation, device embolization, and occurrence of pericardial effusion
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. SAEs include cardiac death, CS perforation, device embolization, and cardiac tamponade
Time frame: Through 30 days post-procedure
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