Lower Silesia Sinus Reducer Registry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Coronary Sinus Reducer Implantation.
- Who it may be relevant to
- Registry conditions: Safety Issues, Efficacy, Self. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Poland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Coronary Sinus Reducer Implantation for Refractory Angina - Long-Term Evaluation of Device Safety and Efficacy- Lower Silesia Sinus Reducer Registry (LSSRR)
Overview
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
- 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.
Primary outcome measures
- The Clinical success - reduction of angina symptoms [Time frame: 1-Year after implantation]
Secondary outcome measures (3)
- Incidence of Treatment-Emergent Adverse Events [Time frame: 1-Year after implantation]
- Change in potential aerobic capacity and endurance - The six minute walking test (6MWT) [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. [Time frame: 1-Year after implantation]
Eligibility criteria
Inclusion criteria
- present of chronic disabling refractory angina pectoris (Canadian Cardiovascular Society \[CCS\] classes 2-4) despite maximally tolerated anti-angina medical therapy
- Heart team evaluation with consideration of ineligibility for percutaneous or surgical revascularization procedures.
Exclusion criteria
- recent acute coronary syndrome (<3 months),
- recent coronary revascularization (<3 months)
- a mean right atrial pressure higher than 15 mm Hg
- coronary sinus proximal diameter <10mm and >14mm
- life expectancy under 12 months,
- advanced heart failure (New York Heart Association \[NYHA\] Classification - classes 3-4),
- potential implantable cardiac resynchronization therapy defibrillator (CRT-D) implantation candidate.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Poland · 2 centers
- Department of Cardiology, The Copper Health Centre (MCZ) — Lubin
- Cardiac Department of Copper Health Center — Lubin
Publications
- Wlodarczak S, Rola P, Jastrzebski A, Woitek F, Barycki M, Furtan L, Doroszko A, Wlodarczak A, Grygier M, Lesiak M. Coronary Sinus Reducer implantation in refractory angina: Short-term outcomes based on the Lower Silesia Sinus Reducer Registry (LSSRR). Kardiol Pol. 2023;81(5):508-511. doi: 10.33963/KP.a2023.0057. Epub 2023 Mar 5. No abstract available. PMID 36871301
- Wlodarczak S, Rola P, Jastrzebski A, Barycki M, Furtan L, Wlodarczak P, Kulczycki JJ, Korda A, Turkiewicz K, Wlodarczak A, Lesiak M. Effectiveness of coronary sinus reducer implantation in routine clinical practice: 12-month outcomes. Pol Arch Intern Med. 2025 May 29;135(5):16986. doi: 10.20452/pamw.16986. Epub 2025 Apr 4. PMID 40192527
Identifiers
NCT: NCT06288165 · CopperHealthCentre2