Efficacy, Self, Safety Issues
Conditions
Keywords
Coronary Sinus Reducer, Refractory angina, Chronic coronary artery diseases (CAD), Non-obstructive Coronary artery diseases (CAD), Coronary microvascular dysfunction
Brief summary
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 .
Detailed description
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.
Interventions
DEVICECoronary 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.
Sponsors
Regional Cardiology Center, The Copper Health Centre (MCZ),
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Clinical success - reduction of angina symptoms | 1-Year after implantation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | 1-Year after implantation | 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) |
| Change in potential aerobic capacity and endurance - The six minute walking test (6MWT) | 1-Year after implantation | 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 |
| Reducing the severity of angina and it impact on quality of life, as shown by the Seattle Angina Questionnaire. | 1-Year after implantation | 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. |
Countries
Poland
Contacts
Primary ContactAdrian Włodarczak, Prof.
Backup ContactSzymon Włodarczak, MD
Outcome results
None listed