Safety IssuesLSSRRNCT06288165
Lower Silesia Sinus Reducer Registry
An observational study of Safety Issues and Efficacy, Self, run by Miedziowe Centrum Zdrowia SA at 2 sites in Poland.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Safety Issues, Efficacy, Self
- What is being tested?
- Coronary Sinus Reducer Implantation
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 2 sitesPoland
- Study dates
- 11 May 2022to 11 May 2027
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Poland2 sites, 2 recruiting
- Recruiting
Department of Cardiology, The Copper Health Centre (MCZ)
Lubin, Lower Silesian Voivodeship, 59-300
Adrian Włodarczak, M.D; Ph.D.Assoc Prof., +48768460300, wlodarczak.adrian@gmail.com
Szymon Włodarczak, MD, +4876 846 03 00, wlodarczak.szy@gmail.com
- Recruiting
Cardiac Department of Copper Health Center
Lubin, Lower Silesian Voivodeship, 59301
Adrian Włodarczak, Prof, 76 846 03 00 ext. 0048, wlodarczak.adrian@gmail.com
Szymon Włodarczak, MD, 76 846 03 00 ext. 0048, wlodarczak.szy@gmail.com
About this study
Official title: 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 .
Read the 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.
- Conditions
- Safety Issues, Efficacy, Self
- Being tested
- Coronary Sinus Reducer Implantation
- Keywords
- Coronary Sinus Reducer, Refractory angina, Chronic coronary artery diseases (CAD), Non-obstructive Coronary artery diseases (CAD), Coronary microvascular dysfunction
- Medical subject headings
- Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary Sinus Reducer ImplantationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Coronary Sinus Reducer Implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1-Year after implantation
Secondary outcomes (3)
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)
Measured: 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
Measured: 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.
Measured: 1-Year after implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2024
- Study start11 May 2022
- Primary completion11 May 2027 (estimated)
- Study completion11 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Safety IssuesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Miedziowe Centrum Zdrowia SA
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adrian Włodarczak, Miedziowe Centrum Zdrowia SA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06288165
- Sponsor's protocol ID
- CopperHealthCentre2
- Acronym
- LSSRR
- Status last verified
- Feb 2024
- First submitted
- 18 Feb 2024
- Last updated
- 1 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 36871301Wlodarczak 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.
PubMed 40192527
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronary Sinus Reducer Implantation for Refractory Angina - Long-Term Evaluation of Device Safety and Efficacy- Lower Silesia Sinus Reducer Registry (LSSRR)
- ClinicalTrials.gov ID
- NCT06288165
- Acronym / sponsor ID
- LSSRR / CopperHealthCentre2
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Miedziowe Centrum Zdrowia SAUniversity, hospital or other
- Study start
- 11 May 2022 (actual)
- Primary completion
- 11 May 2027 (estimated)
- Study completion
- 11 May 2027 (estimated)
- First posted
- 1 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Coronary Sinus Reducer implantation | – | Device: Coronary Sinus Reducer ImplantationSubject 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coronary Sinus Reducer ImplantationCoronary 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. | Device | Coronary Sinus Reducer implantation |
Primary outcome
The Clinical success - reduction of angina symptoms
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.
3 secondary outcomes
Incidence of Treatment-Emergent Adverse Events
Time frame: 1-Year after implantation
Change in potential aerobic capacity and endurance - The six minute walking test (6MWT)
Time frame: 1-Year after implantation
Reducing the severity of angina and it impact on quality of life, as shown by the Seattle Angina Questionnaire.
Time frame: 1-Year after implantation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
- Results publication: PubMed 36871301Wlodarczak 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.
- Derived from this study: PubMed 40192527Wlodarczak 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Safety Issues and Efficacy, Self, run by Miedziowe Centrum Zdrowia SA at 2 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adrian Włodarczak, Prof. (0048768460-285, wlodarczak.adrian@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Clinical success - reduction of angina symptoms (time frame: 1-Year after implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06288165, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2024; AzTrials last refreshed its copy on 28 Oct 2026.