Lower Silesia Sinus Reducer Registry

NCT06288165 | Recruiting

• 1 other identifier: CopperHealthCentre2
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

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 .

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

Outcome Measures

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.

  1-Year after implantation

Secondary Outcomes (3)

• Incidence of Treatment-Emergent Adverse Events

  1-Year after implantation

• Change in potential aerobic capacity and endurance - The six minute walking test (6MWT)

  1-Year after implantation

• Reducing the severity of angina and it impact on quality of life, as shown by the Seattle Angina Questionnaire.

  1-Year after implantation

Study Arms (1)

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

Interventions

Coronary Sinus Reducer Implantation DEVICE

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.

Coronary Sinus Reducer implantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (2)

Department of Cardiology, The Copper Health Centre (MCZ)

Lubin, Lower Silesian Voivodeship, 59-300, Poland

RECRUITING

Cardiac Department of Copper Health Center

Lubin, Lower Silesian Voivodeship, 59301, Poland

RECRUITING

Related Publications (2)

• 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 RESULT

• 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 DERIVED

MeSH Terms

Conditions

Angina Pectoris

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Adrian Włodarczak, Prof.

CONTACT

0048768460-285; wlodarczak.adrian@gmail.com

Szymon Włodarczak, MD

CONTACT

0048 693-350-846; wlodarczak.szy@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Profesaor

Study Record Dates

• First Submitted: February 18, 2024
• First Posted: March 1, 2024
• Study Start: May 11, 2022
• Primary Completion (Estimated): May 11, 2027
• Study Completion (Estimated): May 11, 2027
• Last Updated: March 1, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

PL (2)