Recruiting

Testing a Device to Relieve Severe Heart Pain When Other Treatments Failed

Plain-English translation of NCT05102019 on ClinicalTrials.gov ↗ · Source last updated August 2026 · Translation generated August 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 study is testing a device called the Coronary Sinus Reducer, which is implanted through a minimally invasive procedure to help reduce severe chest pain (angina) that hasn't responded to medication. You would be randomly assigned to either receive the device or a sham procedure (fake treatment), so neither you nor your doctors would know which group you're in during the study. The goal is to see if this treatment can safely and effectively relieve your symptoms.

Some patients with severe heart disease experience chest pain that doesn't improve even when taking the strongest available heart medications and cannot have surgery or angioplasty. Researchers developed this device to offer these patients another option for pain relief.

Do you qualify?

You likely qualify if…

you are older than 18 years old
you have had severe chest pain (angina, CCS Grade III or IV) for at least 90 days despite taking maximum doses of heart medications
you have tried at least three different classes of anti-angina medications (or ideally all four approved types) at their highest tolerated doses, and your medication regimen has been stable for at least 30 days
you have no suitable options for heart surgery or angioplasty, or you are at very high risk for these procedures as determined by your heart care team
you have evidence of reduced blood flow to your heart confirmed by a stress test (exercise test, nuclear scan, ultrasound, or similar study) performed within the last 12 months
you can exercise for 2 to 10 minutes on a treadmill test while taking your current heart medications

You likely don't qualify if…

you have had a heart attack, heart surgery, or angioplasty within the past 12 months (unless a new ischemia test has been done since then)
your heart's pumping ability (ejection fraction) is severely reduced below 30 percent
your main symptom limiting activity is shortness of breath rather than chest pain or pressure
you are unwilling or unable to keep your heart medications at the same dose for at least 12 months after enrollment

What participation looks like

If you qualify and enroll, you will have the Reducer device implanted through a catheter-based procedure (similar to an angiogram), or you will receive a sham procedure. Neither you nor your study team will know which you received until the study ends. You will have follow-up visits to monitor your symptoms, exercise tolerance, and overall heart health over the course of the trial. The study involves exercise tolerance tests and imaging studies to track whether your symptoms improve.

AI-generated summary from trial data · Aug 29, 2026 · Not medical advice

Testing a Device to Relieve Severe Heart Pain When Other Treatments Failed

What is this trial?

Do you qualify?

What participation looks like

Trial locations