Lower Silesia Sinus Reducer Registry (LSSRR)

Coronary Sinus Reducer Implantation for Refractory Angina - Long-Term Evaluation of Device Safety and Efficacy- Lower Silesia Sinus Reducer Registry (LSSRR)

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 .

Study Overview

• Status: Recruiting
• Conditions: Safety Issues; Efficacy, Self
• Intervention / Treatment: Device: 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.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Adrian Włodarczak, Prof.; Phone Number: 0048768460-285; Email: wlodarczak.adrian@gmail.com
• Study Contact Backup: Name: Szymon Włodarczak, MD; Phone Number: 0048 693-350-846; Email: wlodarczak.szy@gmail.com

Study Locations

• Poland
  • Lower Silesia
    • Lubin, Lower Silesia, Poland, 59-300
      • Recruiting
      • Department of Cardiology, The Copper Health Centre (MCZ)
      • Contact: Adrian Włodarczak, M.D; Ph.D.Assoc Prof.; Phone Number: +48768460300; Email: wlodarczak.adrian@gmail.com
      • Contact: Szymon Włodarczak, MD; Phone Number: +4876 846 03 00; Email: wlodarczak.szy@gmail.com
    • Lubin, Lower Silesia, Poland, 59301
      • Recruiting
      • Cardiac Department of Copper Health Center
      • Contact: Adrian Włodarczak, Prof; Phone Number: 0048 76 846 03 00; Email: wlodarczak.adrian@gmail.com
      • Contact: Szymon Włodarczak, MD; Phone Number: 0048 76 846 03 00; Email: wlodarczak.szy@gmail.com
      • Sub-Investigator: Piotr Rola, Ph D; MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Coronary Sinus Reducer implantation; Subject after Coronary Sinus Reducer implantation due to chronic disabling refractory angina pectoris (Canadian Cardiovascular Society [CCS] classes 2-4) despite maximally tolerated anti-angina medical therapy. 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 meet one of the exclusion criteria. Initial patient evaluation (prior to device implantation) consists 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 is scheduled 1 month after the implantation procedure than the follow-up is planned twice a year.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1-Year after implantation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	1-Year after implantation
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	1-Year after implantation
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.	1-Year after implantation

Collaborators and Investigators

• Sponsor: Regional Cardiology Center, The Copper Health Centre (MCZ),

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2022
• Primary Completion (Estimated): May 11, 2027
• Study Completion (Estimated): May 11, 2027

Study Registration Dates

• First Submitted: February 18, 2024
• First Submitted That Met QC Criteria: February 24, 2024
• First Posted (Estimated): March 1, 2024

Study Record Updates

• Last Update Posted (Estimated): March 1, 2024
• Last Update Submitted That Met QC Criteria: February 24, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Coronary Sinus Reducer; Refractory angina; Coronary microvascular dysfunction; Chronic coronary artery diseases (CAD); Non-obstructive Coronary artery diseases (CAD)
• Other Study ID Numbers: CopperHealthCentre2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No