Coronary Sinus Reducer for Angina Without Blocked Arteries

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial implants a coronary sinus reducer to narrow the coronary sinus and raise venous pressure in the heart, aiming to alter myocardial perfusion for symptom relief. Participants must have stable angina without significant epicardial stenosis and invasive confirmation of coronary microvascular dysfunction (CFR ≤ 2.5 or IMR ≥ 25) after at least three months of maximal antianginal therapy. Key exclusions include vasospastic angina, significant valvular disease, severe left ventricular dysfunction (EF ≤ 30%), recent acute coronary syndrome or revascularization, and other conditions that increase procedural risk. The study will track changes in symptoms and microvascular physiological indices, building on limited observational data suggesting benefit.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Stable angina symptoms without significant obstruction of coronary artery (defined as coronary artery stenosis diameter ≤ 50% or coronary artery stenosis diameter \>50% and ≤70% with FFR\>0.8), with coronary microvascular dysfunction confirmed in invasive test (defined as coronary flow reserve ≤ 2.5 or index of microvascular resistance ≥ 25)
* No future options for antianginal therapy (maximum antianginal therapy for at least three months)

Exclusion Criteria:

* Vasospastic angina (positive test with acetylcholine),
* Evidence of cardiac ischemia,
* Coronary flow limiting myocardial bridge,
* Severe valvular disease
* Hospitalization for acute heart failure \< 3 months
* Hypertrophic cardiomyopathy,
* Ejection fraction ≤ 30%,
* Permanent pacemaker or defibrillator leads in the right heart,
* Recent acute coronary syndrome \< 6 months,
* Recent revascularization \< 2 months,
* Right atrial pressure of 15 mmHg or higher,
* Severe renal impairment,
* Indication for cardiac resynchronization therapy,
* Pregnancy,
* Life expectancy of less than 1 year,
* Inclusion in another clinical trial

Where it's running

• Medical University of Warsaw
  Warsaw, Poland Recruiting

Study contacts

• Study coordinator: Mariusz Tomaniak, Professor
• Email: mariusz.tomaniak@wum.edu.pl
• Phone: +48 22 5991951

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.