Self-Expanding Coronary Sinus Reducer for Treatment of Symptomatic Coronary Microvascular Dysfunction (CMD) (SERRA-I Study)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVahatiCor, Inc.
About this trial
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
Qualifiers
Older than 18 years of age.
Left ventricular ejection fraction (LVEF) is greater than or equal to 25% within the 12 months before the index procedure.
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.
CFR<2.5 measured with continuous thermodilution within 30 days of index procedure.
Disqualifiers
Significant obstructive epicardial disease (greater than 50% diameter stenosis) that can be treated with PCI or CABG as determined by Investigator and confirmed by the Central Screening Committee.
Recent (less than 30 days before index procedure) troponin or CKMB positive acute coronary syndrome (NSTEMI or STEMI) with evidence of ischemia.
Extra-coronary contributory causes of angina - e.g., untreated hyperthyroidism, anemia (Hgb less than 9 g/dL), uncontrolled hypertension (systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 100 mmHg despite medications), atrial fibrillation with a rapid ventricular response (consistently greater than 100 bpm despite medications) or other tachyarrhythmia, severe aortic stenosis, decompensated heart failure, hypertrophic cardiomyopathy with left ventricular outflow tract obstruction or asymmetric septal hypertrophy (concentric left ventricular hypertrophy is not an exclusion criterion).
NYHA class IV or decompensated HF or hospitalization due to HF during the 90 days before the index procedure.
Trial design
Treatments tested in this trial
- A-FLUX Reducer System
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov