Self-Expanding Coronary Sinus Reducer for Treatment of Symptomatic Coronary Microvascular Dysfunction (CMD)
VahatiCor, Inc.
Summary
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion criteria 1. Older than 18 years of age. 2. Left ventricular ejection fraction (LVEF) is greater than or equal to 25% within the 12 months before the index procedure. Note: The LVEF must be reassessed after any intervening myocardial infarction. The most recent LVEF assessment is used as the qualifying test for subjects with multiple assessments 3. Greater than or equal to 30 days of persistent symptomatic coronary microvascular dysfunction (angina pectoris, or equivalent symptoms) (classified as CCS Grade II - IV angina, or NYHA Class 2 or 3 equivalent non-anginal functional impairm…
Interventions
- DeviceA-FLUX Reducer System
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.
Locations (2)
- Yale UniversityNew Haven, Connecticut
- The Lindner Research Center at The Christ HospitalCincinnati, Ohio