Lower Silesia Sinus Reducer Registry

Safety Issues Clinical Trial

— LSSRR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06288165
• Other study ID #: CopperHealthCentre2
• Status: Recruiting
• Start date: May 11, 2022
• Est. completion date: May 11, 2027

Study information

• Verified date: February 2024
• Source: Regional Cardiology Center, The Copper Health Centre (MCZ),
• Contact: Adrian Wlodarczak, Prof.
• Phone: 0048768460-285
• Email: wlodarczak.adrian[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 .

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: May 11, 2027
• Est. primary completion date: May 11, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Efficacy, Self
• Safety Issues

Intervention

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.

Locations

Country	Name	City	State
Poland	Cardiac Department of Copper Health Center	Lubin	Lower Silesia
Poland	Department of Cardiology, The Copper Health Centre (MCZ)	Lubin	Lower Silesia

Sponsors (1)

Lead Sponsor	Collaborator
Regional Cardiology Center, The Copper Health Centre (MCZ),

Country where clinical trial is conducted

Poland, 

References & Publications (1)

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). Kar — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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