No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
200 (estimated)
Sponsor
Regional Cardiology Center, The Copper Health Centre (MCZ), · Other
Who this trial is looking for
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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 .
Trial Locations
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Status
Eligibility Criteria
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 pr…
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.
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