Not Yet RecruitingNot Applicable

Self Expanding Coronary Sinus Reducer for Treatment of Symptomatic Coronary Microvascular Dysfunction (CMD)

30 participantsStarted 2026-04

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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. 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
✓. 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.
✓. CFR\<2.5 measured with continuous thermodilution within 30 days of index procedure. Note: CFR assessment may be completed during index procedure by Sponsor approved Investigators. RCA measurements are not permitted for this study.
✓. Sustained angina (or equivalent symptoms) reported for at least 2 weeks leading up to the index procedure, as reported via the ORBITA-app.
✓. Willing and able to sign informed consent.
✓. Willing to comply with the specified follow-up evaluations.
✓. Mean right atrial pressure ≤15 mmHg.

Exclusion criteria

✕. 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.
✕. Life-threatening rhythm disorders or any rhythm disorders that would require cardiac resynchronization therapy or lead placement in the coronary sinus.
✕. Severe chronic obstructive pulmonary disease (COPD) as indicated by a forced expiratory volume in one second (FEV1) of less than 1.0L or need for home daytime oxygen or regular oral steroids.
✕. Severe valvular heart disease (any valve).
✕. Moderate (TAPSE\<12) or severe RV dysfunction (TAPSE\<8) by echocardiography.

What they're measuring

Procedural Success

Timeframe: Throughout the study, up to 12 months post-procedure

Safety: Rate of device- and procedure- related SAEs

Timeframe: Through 30 days post-procedure

Trial details

NCT IDNCT07449325

SponsorVahatiCor, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-11

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