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Lower Silesia Sinus Reducer Registry
RECRUITINGSponsored by Regional Cardiology Center, The Copper Health Centre (MCZ),
Actively Recruiting
SponsorRegional Cardiology Center, The Copper Health Centre (MCZ),
Started2022-05-11
Est. completion2027-05-11
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06288165
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
Age: 18 Years+Healthy volunteers accepted
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.
Conditions3
Efficacy, SelfHeart DiseaseSafety Issues
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Actively Recruiting
SponsorRegional Cardiology Center, The Copper Health Centre (MCZ),
Started2022-05-11
Est. completion2027-05-11
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06288165