Lower Silesia Sinus Reducer Registry

Launched by REGIONAL CARDIOLOGY CENTER, THE COPPER HEALTH CENTRE (MCZ), · Feb 24, 2024

Keywords

ClinConnect Summary

The Lower Silesia Sinus Reducer Registry is a clinical trial that aims to study the safety and effectiveness of a device called a Coronary Sinus Reducer in patients who suffer from chronic, disabling angina pectoris. Angina pectoris is chest pain or discomfort that occurs when the heart doesn’t get enough oxygen-rich blood, and this trial focuses on patients whose symptoms persist even after taking the best available heart medications. To be eligible for this study, participants should be between the ages of 65 and 74, have been evaluated by a medical team, and are not suitable for other heart procedures like surgery.

If you choose to participate, you will receive the Coronary Sinus Reducer implant, and the trial will track your health and symptoms over time to see how well the device works. It’s important to note that certain conditions, such as recent heart attacks, severe heart failure, or a very short life expectancy, may make someone ineligible for this study. Overall, this trial hopes to provide valuable information that could help improve treatment options for patients with ongoing angina.

Gender

ALL

Eligibility criteria

• 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.