Lower Silesia Sinus Reducer Registry

Recruiting now

Conditions studied: Safety Issues, Efficacy, Self

In brief

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 .

Key facts

Study ID

NCT06288165

Run by

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

People needed

200

Starts

2022-05-11

Expected to finish

2027-05-11

Last updated by the study team

2024-03-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Department of Cardiology, The Copper Health Centre (MCZ) — Lubin, Lower Silesian Voivodeship, Poland (enrolling)
• Cardiac Department of Copper Health Center — Lubin, Lower Silesian Voivodeship, Poland (enrolling)

Full record on ClinicalTrials.gov

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