RECRUITINGOBSERVATIONAL
Lower Silesia Sinus Reducer Registry
Coronary Sinus Reducer Implantation for Refractory Angina - Long-Term Evaluation of Device Safety and Efficacy- Lower Silesia Sinus Reducer Registry (LSSRR)
About This Trial
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 .
Who May Be Eligible (Plain English)
Who May Qualify:
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.
Who Should NOT Join This Trial:
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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
DEVICE
Coronary Sinus Reducer Implantation
Coronary Sinus (CS) Reducer implantation to coronary sinus via the venous system. Coronary Sinus is a balloon-expandable, hourglass-shaped, scaffold implanted percutaneously into the coronary sinus creating a narrowing to delay blood outflow.
Locations (2)
Department of Cardiology, The Copper Health Centre (MCZ)
Lubin, Lower Silesian Voivodeship, Poland
Cardiac Department of Copper Health Center
Lubin, Lower Silesian Voivodeship, Poland