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Recruiting
NCT07449325
Self Expanding Coronary Sinus Reducer for Treatment of Symptomatic Coronary Microvascular Dysfunction (CMD)
Conditions: Angina Pectoris, Myocardial Ischemia, Heart Diseases, Cardiovascular Diseases, Vascular Diseases, Microvascular Angina
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 30
Sponsor: VahatiCor, Inc.
Location: Yale University New Haven Connecticut
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 Criteria
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 impairment) despite optimal medical therapy, as determined by Investigator and confirmed by the Central Screening Committee. Note: Optimal medical management is defined as at least 2 anti-anginal medications or maximally tolerated medical therapy if less than 2 anti-anginal medications.
4. CFR\
Source: ClinicalTrials.gov (NCT07449325). StuddyBuddy aggregates publicly available trial information.