Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
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\

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07449325). StuddyBuddy aggregates publicly available trial information.