Long-term safety of a coronary sinus device for chest pain

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with long-lasting, severe chest pain from the heart (angina) who still have pain despite the most medicine they can tolerate. They must be unable to have stenting or bypass surgery, and are getting a Coronary Sinus Reducer implant.

Age

18 years or older

Sex

All sexes can join.

Disease stage

Disabling refractory angina, Canadian Cardiovascular Society (CCS) classes 2-4, despite maximally tolerated anti-angina medicine. The heart team judged that stenting or bypass surgery is not an option.

Earlier treatment

Maximally tolerated anti-angina medicine. A recent acute coronary syndrome or heart revascularization procedure in the last 3 months is not allowed.

Main reasons for not taking part

• Acute coronary syndrome in the last 3 months
• Coronary revascularization in the last 3 months
• Mean right atrial pressure higher than 15 mm Hg
• Coronary sinus proximal diameter under 10mm or over 14mm
• Life expectancy under 12 months

The registry criteria, word for word

What the trial wants to find out

Lower Silesia Sinus Reducer Registry is a , single-center, single-arm registry including patients with chronic disabling refractory angina pectoris (Canadian Cardiovascular Society [CCS] classes 2-4) despite maximally tolerated anti-angina medical therapy who underwent Coronary Sinus Reducer implantation .

The group in the trial

• Coronary Sinus Reducer implantation

  Subject after Coronary Sinus Reducer implantation due to chronic disabling refractory angina pectoris (Canadian Cardiovascular Society \[CCS\] classes 2-4) despite maximally tolerated anti-angina medical therapy. All patients were evaluated by the local Heart Team and considered not amenable to percutaneous or surgical revascularization procedures. After the Heart Team evaluation patients were qualified for the procedure or Coronary Sinus Reducer implantation unless they meet one of the exclusion criteria. Initial patient evaluation (prior to device implantation) consists of past medical history, actual clinical assessment with an evaluation of CCS class, Seattle Angina Questionnaire - 7 items (SAQ-7) scores, 6-min walk distance (6-MWT) test, and echocardiography. First, a follow-up visit is scheduled 1 month after the implantation procedure than the follow-up is planned twice a year.