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NCT06288165Recruiting

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)

Source: ClinicalTrials.gov · Last updated 1 Mar 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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 .

Status (registry)
Recruiting
Study type
Observational
Enrollment
200 (estimated)
First submitted
18 Feb 2024
Start date
11 May 2022
Primary completion date
11 May 2027
Lead sponsor
Miedziowe Centrum Zdrowia SA
NCT number
NCT06288165

What you commit to

  • Study type: Observational
  • Planned participants: 200
  • From 11 May 2022 to the primary completion date, 11 May 2027
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • recent acute coronary syndrome (\<3 months),
  • advanced heart failure (New York Heart Association \[NYHA\] Classification - classes 3-4),
  • potential implantable cardiac resynchronization therapy defibrillator (CRT-D) implantation candidate.

Other

  • 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,

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Department of Cardiology, The Copper Health Centre (MCZ)
Coordinator of this site? Confirm its status
LubinPolandRecruiting
Cardiac Department of Copper Health Center
Coordinator of this site? Confirm its status
LubinPolandRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.