Recruiting

Testing a device to relieve chest pain from small blood vessel problems

Plain-English translation of NCT07449325 on ClinicalTrials.gov ↗ · Source last updated May 2026 · Translation generated June 2026 · How we translate trials

This study doesn't follow the usual testing phases — it may be an observational study or a different type of research.

What is this trial?

This early-stage trial is testing a device called the A-FLUX Coronary Sinus Reducer, which is designed to help people with chest pain caused by coronary microvascular dysfunction—a condition where the smallest blood vessels in the heart aren't working properly. The device is placed in a vein near the heart to improve blood flow and reduce symptoms. This study will look at whether the device is safe and works well for people whose chest pain hasn't gotten better with medication.

Many people experience chest pain caused by problems in the heart's smallest blood vessels, and standard medications don't always relieve their symptoms. This trial exists to see if this new device offers a treatment option for those patients.

Do you qualify?

You likely qualify if…

you are at least 18 years old
you have had chest pain or similar symptoms for at least 30 days despite being on at least two heart medications or the maximum tolerated dose of medication
you have ongoing chest pain or symptoms for at least 2 weeks leading up to the procedure
your heart's main pumping chamber is functioning at 25% or better
a test shows reduced blood flow in the small vessels of your heart (measured as CFR less than 2.5)

You likely don't qualify if…

you have significant blockages in your main coronary arteries that could be treated with balloon angioplasty or bypass surgery
you had a heart attack with elevated heart damage markers within the last 30 days
you have other medical problems that could cause chest pain, such as uncontrolled high blood pressure, untreated hyperthyroidism, or severe anemia
you have uncontrolled irregular heartbeats or decompensated heart failure
your heart's venous anatomy is not suitable for device placement

What participation looks like

If you enroll, you will undergo the device implantation procedure, which involves placing the A-FLUX Coronary Sinus Reducer into a vein near your heart through a catheter (a thin tube). The research team will monitor your heart function before, during, and after the procedure with imaging and pressure measurements. You will then complete follow-up visits as scheduled by the study team to assess your symptoms and the device's safety and performance over time.

AI-generated summary from trial data · Jun 25, 2026 · Not medical advice

Trial locations(2 sites)

United States

Yale University, New Haven, Connecticut

The Lindner Research Center at The Christ Hospital, Cincinnati, Ohio