[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100595822":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":7,"centralContacts":7,"locations":16,"responsibleParty":202,"collaborators":7,"id":204,"slug":205,"hasResults":206,"nctId":207,"briefTitle":208,"officialTitle":208,"acronym":209,"eligibilityCriteria":210,"healthyVolunteers":206,"sex":211,"minAge":212,"maxAge":7,"enrollmentInfo":213,"targetDuration":216,"studyType":217,"phases":7,"briefSummary":218,"conditions":219,"keywords":221,"overallStatus":229,"whyStopped":7,"lastUpdateSubmitDate":230,"lastUpdatePostDateStruct":231,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":238,"locationsCount":239},{"fullName":5,"class":6},"Occlutech International AB","INDUSTRY",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":13},"DEVICE","Transcatheter paravalvular leak closure device","Transcatheter closure of clinically significant mitral or aortic paravalvular leak (PVL) using the Occlutech Paravalvular Leak Device (PLD) in routine clinical practice. 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The procedure may be performed via an appropriate access route (eg, transseptal\u002Fretrograde\u002Ftransapical) based on patient anatomy and operator assessment.",[14,15],"Occlutech Paravalvular Leak Device","Occlutech PLD",[17,22,31,39,47,57,65,73,83,88,96,106,114,124,135,145,155,165,172,182,187,195],{"facility":18,"status":7,"city":19,"state":7,"zip":7,"country":20,"countryCode":21,"cosmosGeoPoint":7,"geoPoint":7,"contacts":7},"Medical University of Silesia","Katowice","France","FR",{"facility":23,"status":7,"city":24,"state":7,"zip":7,"country":20,"countryCode":21,"cosmosGeoPoint":25,"geoPoint":30,"contacts":7},"À l'Infirmerie Protestante de Lyon","Lyon",{"type":26,"coordinates":27},"Point",[28,29],4.84789,45.74906,{"lat":29,"lon":28},{"facility":32,"status":7,"city":33,"state":7,"zip":7,"country":20,"countryCode":21,"cosmosGeoPoint":34,"geoPoint":38,"contacts":7},"Hôpital 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Hastanesi","Istanbul","Küçükçekmece","34303",{"type":26,"coordinates":151},[152,153],28.94966,41.01384,{"lat":153,"lon":152},{"facility":156,"status":7,"city":157,"state":158,"zip":159,"country":129,"countryCode":7,"cosmosGeoPoint":160,"geoPoint":164,"contacts":7},"Tekirdağ Namık Kemal Üniversitesi Hastanesi","Tekirdağ","Süleymanpaşa","59100",{"type":26,"coordinates":161},[162,163],27.51101,40.9781,{"lat":163,"lon":162},{"facility":166,"status":7,"city":137,"state":167,"zip":168,"country":129,"countryCode":7,"cosmosGeoPoint":169,"geoPoint":171,"contacts":7},"SBÜ Etlik Şehir Hastanesi Göğüs Kalp ve Damar Hastalıkları","Yenimahalle","06170",{"type":26,"coordinates":170},[142,143],{"lat":143,"lon":142},{"facility":173,"status":7,"city":174,"state":175,"zip":176,"country":129,"countryCode":7,"cosmosGeoPoint":177,"geoPoint":181,"contacts":7},"SBÜ Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi","Bursa","Yıldırım","16310",{"type":26,"coordinates":178},[179,180],29.06013,40.19559,{"lat":180,"lon":179},{"facility":183,"status":7,"city":137,"state":7,"zip":7,"country":129,"countryCode":7,"cosmosGeoPoint":184,"geoPoint":186,"contacts":7},"Hacettepe Üniversitesi",{"type":26,"coordinates":185},[142,143],{"lat":143,"lon":142},{"facility":188,"status":7,"city":189,"state":7,"zip":7,"country":129,"countryCode":7,"cosmosGeoPoint":190,"geoPoint":194,"contacts":7},"Kocaeli Üniversitesi Hastanesi","Kocaeli",{"type":26,"coordinates":191},[192,193],27.51145,39.62497,{"lat":193,"lon":192},{"facility":196,"status":7,"city":137,"state":197,"zip":198,"country":129,"countryCode":7,"cosmosGeoPoint":199,"geoPoint":201,"contacts":7},"Özel Ankara Güven Hastanesi","Çankaya","06540",{"type":26,"coordinates":200},[142,143],{"lat":143,"lon":142},{"type":203,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100595822","a-multicenter-international-prospective-and-retrospective-follow-up-registry-to-monitor-the-efficacy-and-safety-of-the-occlutech-paravalvular-leak-device-pld-in-patients-with-mitral-or-aortic-paravalvular-leaks-100595822",false,"NCT07037446","A Multicenter, International, Prospective and Retrospective, Follow-up Registry to Monitor the Efficacy and Safety of the Occlutech Paravalvular Leak Device (PLD) in Patients With Mitral or Aortic Paravalvular Leaks","PLD REGISTRY","Inclusion Criteria:\n\n• Patient meeting the indication and area of application of the PLD device as laid down in the IFU.\n\nThe Occlutech® PLD is indicated for patients with a significant leak that causes hemodynamically significant heart failure or hemolysis which requires recurrent blood transfusions. It is further indicated for patients who are deemed at high risk for surgery after consultation with the surgeon or as an alternative to surgery with less operational time and recovery period.\n\n* Male of female patients\n* Patients of age ≥ 18 years\n* Patients understanding the nature of the study and providing their informed consent to participation.\n* Patients willing and able to attend the follow-up visits and procedures foreseen by study CIP.\n\nExclusion Criteria:\n\n* Contraindications as described in the IFU:\n* Acute infection or any serious infection 1 month prior to procedure\n* Adequate oral anti-coagulation therapy \u002F platelet inhibition is not possible post-intervention.\n* Allergies to nickel and\u002For titanium and\u002For nickel\u002Ftitanium-based materials\n* Intolerance to contrast agents\n* Known coagulation disorder\n* Known intra-cardiac thrombus\n* Recent pelvic venous thrombosis\n* Recent myocardial infarction or a surgical bypass operation in the last 30 days Note: a positive result to a pregnancy test necessitates the exclusion of the subject from the registry.","ALL","18 Years",{"count":214,"type":215},200,"ESTIMATED","3 Years","OBSERVATIONAL","This is an international, multicenter, retrospective and prospective post-marketing follow-up registry designed to monitor the safety and efficacy of the Occlutech Paravalvular Leak Device (PLD) in patients with clinically significant mitral or aortic paravalvular leaks after previously implanted prosthetic heart valves who undergo transcatheter PVL closure in routine clinical practice. Up to 200 subjects are planned to be enrolled and followed after the procedure (Day 1-7, Day 30, 6-12 months, and annually up to 3 years) to evaluate device safety (including serious adverse device effects) and effectiveness, including reduction of paravalvular regurgitation assessed by echocardiography and clinical outcomes such as improvement in heart failure symptoms and\u002For reduced need for hemolysis-related transfusions.",[220],"Paravalvular Leak",[222,223,224,15,225,226,227,228],"PLD Registry","Paravalvular leak (PVL)","Transcatheter paravalvular leak closure","PLD","Prosthetic heart valve","Mitral PVL","Aortic PVL","ENROLLING_BY_INVITATION","2026-07-29",{"date":232,"type":233},"2026-07-31","ACTUAL",{"date":235,"type":233},"2025-02-05",{"date":237,"type":215},"2030-12-31",{"name":5,"class":6},22]