Lower Silesia Sinus Reducer Registry
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRegional Cardiology Center, The Copper Health Centre (MCZ),
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 .
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial population
The study population will consist of subjects with chronic disabling refractory angina pectoris (Canadian Cardiovascular Society \[CCS\] classes 2-4) who have not responded to treatment with maximally tolerated anti-angina medical therapy. The local Heart Team will evaluate all patients and determine that they are not suitable for percutaneous or surgical revascularization procedures. Following the Heart Team evaluation, patients who do not have any revascularization options available to them are eligible for the procedure or Coronary Sinus Reducer implantation, unless they meet one of the exclusion criteria.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Coronary Sinus Reducer Implantation
DeviceCoronary 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.
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: Coronary Sinus Reducer implantation1 intervention
Trial outcomes
Primary outcomes
1
The 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 implantationSecondary outcomes
1
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 implantation2
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 implantation3
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 implantationSponsors and contacts
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Source ClinicalTrials.gov