NCT Number: NCT06288165
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 .
Interested in participating?
Request Info18 year and older
All sexes
Observational
Cardiac Department of Copper Health Center, Lubin, Lower Silesian Voivodeship, Poland
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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.
Time frame: 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)
Time frame: 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
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Adrian Włodarczak, Prof.
CONTACT
Szymon Włodarczak, MD
CONTACT
Regional Cardiology Center, The Copper Health Centre (MCZ),
Other
Coronary Sinus Reducer Implantation for Refractory Angina - Long-Term Evaluation of Device Safety and Efficacy- Lower Silesia Sinus Reducer Registry (LSSRR)
Acronym: LSSRR
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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