NCT06288165

Lower Silesia Sinus Reducer Registry

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Regional Cardiology Center, The Copper Health Centre (MCZ), · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Safety Issues
• Efficacy, Self

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-05-11
• Primary completion: 2027-05-11
• Completion: 2027-05-11
• First posted: 2024-03-01
• Last updated: 2024-03-01

Locations

2 sites across 1 country: Poland