RecruitingNCT06288165

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)

Sponsor

Regional Cardiology Center, The Copper Health Centre (MCZ),

Enrollment

200 participants

Start Date

May 11, 2022

Study Type

OBSERVATIONAL

Conditions

Efficacy, Self Safety Issues

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 .

Eligibility

Min Age: 18 Years

Inclusion Criteria2

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.

Exclusion Criteria7

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.

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Interventions

DEVICECoronary 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.