Self Expanding Coronary Sinus Reducer for Treatment of Symptomatic Coronary Microvascular Dysfunc… (NCT07449325) | Clinical Trial Compass
RecruitingNot Applicable
Self Expanding Coronary Sinus Reducer for Treatment of Symptomatic Coronary Microvascular Dysfunction (CMD)
United States30 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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Procedural Success
Timeframe: Throughout the study, up to 12 months post-procedure
2
Safety: Rate of device- and procedure- related SAEs
. 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.