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 .
Lower Silesia Sinus Reducer Registry is a single-center, single-arm registry including all consecutive patients who were referred to the Cardiac Department of Copper Health Center due to chronic disabling refractory angina pectoris (Canadian Cardiovascular Society \[CCS\] classes 2-4) despite maximally tolerated anti-angina medical therapy and underwent Coronary Sinus Reducer implantation. 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 met one of the exclusion criteria. Initial patient evaluation (prior to device implantation) consisted 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 was scheduled 1 month after the implantation procedure.The study will include clinical assessments every six months during an observation period. The primary outcomes will be gathered one year after the implantation of the CS. Nevertheless, clinical follow-up will continue for up to five years after the procedure.
Study Type
OBSERVATIONAL
Enrollment
200
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.
Department of Cardiology, The Copper Health Centre (MCZ)
Lubin, Lower Silesian Voivodeship, Poland
RECRUITINGCardiac Department of Copper Health Center
Lubin, Lower Silesian Voivodeship, Poland
RECRUITINGThe Clinical success - reduction of angina symptoms
The severity of angina is assessed by the Canadian Cardiovascular Society Scale (CCS) class, which ranges from grade I to IV. A higher CCS grade indicates a greater severity of angina.
Time frame: 1-Year after implantation
Incidence of Treatment-Emergent Adverse Events
Safety outcomes were defined as procedural final serious complications (perforation, abrupt closure, slow flow or no-reflow, unstable ventricular arrhythmias) and device failure (inability to cross coronary sinus, inability to expand; unplanned relocation of the device)
Time frame: 1-Year after implantation
Change in potential aerobic capacity and endurance - The six minute walking test (6MWT)
Change in subjects aerobic capacity and endurance will be assessed using The six minute walking test (6 MWT)- The longer the distance covered, the better the exercise tolerance
Time frame: 1-Year after implantation
Reducing the severity of angina and it impact on quality of life, as shown by the Seattle Angina Questionnaire.
Potential physical and quality of life limitations will be assessed using Seattle Angina Questionnaire-7 (SAQ-7). Summary score can best be understood by categorizing the scores into ranges: 0 to 24 represents poor health status, 25 to 49 as fair, 50 to 74 as good, and 75 to 100 as excellent.
Time frame: 1-Year after implantation
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