Clinical trial NCT06288165: Lower Silesia Sinus Reducer Registry
Official title: Coronary Sinus Reducer Implantation for Refractory Angina - Long-Term Evaluation of Device Safety and Efficacy- Lower Silesia Sinus Reducer Registry (LSSRR)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Safety Issues
Efficacy, Self
Keywords: Coronary Sinus Reducer
Refractory angina
Chronic coronary artery diseases (CAD)
Non-obstructive Coronary artery diseases (CAD)
Coronary microvascular dysfunction
Lead sponsor: Regional Cardiology Center, The Copper Health Centre (MCZ),
Sponsor class: OTHER
First posted: 2024-03-01
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The Clinical success - reduction of angina symptoms
timeFrame: 1-Year after implantation
Secondary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: 1-Year after implantation
measure: Change in potential aerobic capacity and endurance - The six minute walking test (6MWT)
timeFrame: 1-Year after implantation
measure: Reducing the severity of angina and it impact on quality of life, as shown by the Seattle Angina Questionnaire.
timeFrame: 1-Year after implantation
Other outcomes:
Locations:
city: Lubin
country: Poland
facility: Department of Cardiology, The Copper Health Centre (MCZ)
state: Lower Silesia
city: Lubin
country: Poland
facility: Cardiac Department of Copper Health Center
state: Lower Silesia
Study officials:
References:
citation: 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.