Registry for patients with refractory angina undergoing Coronary Sinus Reducer implantation

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 Lower Silesia Sinus Reducer Registry is an observational, single-center registry that includes patients suffering from chronic disabling refractory angina pectoris, classified as CCS classes 2-4, who have not responded to maximally tolerated anti-angina medical therapy. Patients undergo a thorough evaluation by a Heart Team to determine their eligibility for Coronary Sinus Reducer implantation, as they are not suitable for other revascularization procedures. Initial assessments include medical history, clinical evaluations, and various tests, with follow-up visits scheduled at one month and every six months thereafter for up to five years to monitor outcomes. The primary outcomes will be assessed one year post-implantation.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. present of chronic disabling refractory angina pectoris (Canadian Cardiovascular Society \[CCS\] classes 2-4) despite maximally tolerated anti-angina medical therapy
2. Heart team evaluation with consideration of ineligibility for percutaneous or surgical revascularization procedures.

Exclusion Criteria:

1. recent acute coronary syndrome (\<3 months),
2. recent coronary revascularization (\<3 months)
3. a mean right atrial pressure higher than 15 mm Hg
4. coronary sinus proximal diameter \<10mm and \>14mm
5. life expectancy under 12 months,
6. advanced heart failure (New York Heart Association \[NYHA\] Classification - classes 3-4),
7. potential implantable cardiac resynchronization therapy defibrillator (CRT-D) implantation candidate.

Where it's running

• Department of Cardiology, The Copper Health Centre (MCZ)
  Lubin, Lower Silesian Voivodeship, Poland Recruiting
• Cardiac Department of Copper Health Center
  Lubin, Lower Silesian Voivodeship, Poland Recruiting

Study contacts

• Study coordinator: Adrian Włodarczak, Prof.
• Email: wlodarczak.adrian@gmail.com
• Phone: 0048768460-285

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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.