[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100538233":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":20,"locations":30,"responsibleParty":66,"collaborators":10,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":72,"sex":78,"minAge":79,"maxAge":10,"enrollmentInfo":80,"targetDuration":83,"studyType":84,"phases":10,"briefSummary":85,"conditions":86,"keywords":89,"overallStatus":33,"whyStopped":10,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Regional Cardiology Center, The Copper Health Centre (MCZ),","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Coronary Sinus Reducer implantation",null,"Subject after Coronary Sinus Reducer implantation due to chronic disabling refractory angina pectoris (Canadian Cardiovascular Society \\[CCS\\] classes 2-4) despite maximally tolerated anti-angina medical therapy. All patients were evaluated by the local Heart Team and considered not amenable to percutaneous or surgical revascularization procedures. After the Heart Team evaluation patients were qualified for the procedure or Coronary Sinus Reducer implantation unless they meet one of the exclusion criteria. Initial patient evaluation (prior to device implantation) consists of past medical history, actual clinical assessment with an evaluation of CCS class, Seattle Angina Questionnaire - 7 items (SAQ-7) scores, 6-min walk distance (6-MWT) test, and echocardiography. First, a follow-up visit is scheduled 1 month after the implantation procedure than the follow-up is planned twice a year.",[13],"Device: Coronary Sinus Reducer Implantation",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DEVICE","Coronary 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.",[9],[21,26],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},"Adrian Włodarczak, Prof.","CONTACT","0048768460-285","wlodarczak.adrian@gmail.com",{"name":27,"role":23,"phone":28,"phoneExt":10,"email":29},"Szymon Włodarczak, MD","0048 693-350-846","wlodarczak.szy@gmail.com",[31,51],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Department of Cardiology, The Copper Health Centre (MCZ)","RECRUITING","Lubin","Lower Silesian Voivodeship","59-300","Poland","PL",{"type":40,"coordinates":41},"Point",[42,43],16.20149,51.40089,{"lat":43,"lon":42},[46,49],{"name":47,"role":23,"phone":48,"phoneExt":10,"email":25},"Adrian Włodarczak, M.D; Ph.D.Assoc Prof.","+48768460300",{"name":27,"role":23,"phone":50,"phoneExt":10,"email":29},"+4876 846 03 00",{"facility":52,"status":33,"city":34,"state":35,"zip":53,"country":37,"countryCode":38,"cosmosGeoPoint":54,"geoPoint":56,"contacts":57},"Cardiac Department of Copper Health Center","59301",{"type":40,"coordinates":55},[42,43],{"lat":43,"lon":42},[58,62,63],{"name":59,"role":23,"phone":60,"phoneExt":61,"email":25},"Adrian Włodarczak, Prof","76 846 03 00","0048",{"name":27,"role":23,"phone":60,"phoneExt":61,"email":29},{"name":64,"role":65,"phone":10,"phoneExt":10,"email":10},"Piotr Rola, Ph D; MD","SUB_INVESTIGATOR",{"type":67,"investigatorFullName":68,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Adrian Włodarczak","Profesaor","100538233","lower-silesia-sinus-reducer-registry-100538233",false,"NCT06288165","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)","LSSRR","Inclusion Criteria:\n\n1. present of chronic disabling refractory angina pectoris (Canadian Cardiovascular Society \\[CCS\\] classes 2-4) despite maximally tolerated anti-angina medical therapy\n2. Heart team evaluation with consideration of ineligibility for percutaneous or surgical revascularization procedures.\n\nExclusion Criteria:\n\n1. recent acute coronary syndrome (\\\u003C3 months),\n2. recent coronary revascularization (\\\u003C3 months)\n3. a mean right atrial pressure higher than 15 mm Hg\n4. coronary sinus proximal diameter \\\u003C10mm and \\>14mm\n5. life expectancy under 12 months,\n6. advanced heart failure (New York Heart Association \\[NYHA\\] Classification - classes 3-4),\n7. potential implantable cardiac resynchronization therapy defibrillator (CRT-D) implantation candidate.","ALL","18 Years",{"count":81,"type":82},200,"ESTIMATED","5 Years","OBSERVATIONAL","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 .",[87,88],"Safety Issues","Efficacy, Self",[90,91,92,93,94],"Coronary Sinus Reducer","Refractory angina","Chronic coronary artery diseases (CAD)","Non-obstructive Coronary artery diseases (CAD)","Coronary microvascular dysfunction","2024-02-24",{"date":97,"type":98},"2024-03-01","ACTUAL",{"date":100,"type":98},"2022-05-11",{"date":102,"type":82},"2027-05-11",{"name":5,"class":6},2]