{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,16]],"date-time":"2026-07-16T22:44:48Z","timestamp":1784241888730,"version":"3.55.0"},"reference-count":20,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2022,11,15]],"date-time":"2022-11-15T00:00:00Z","timestamp":1668470400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100006520","name":"Edwards Lifesciences","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100006520","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cathet Cardio Intervent"],"published-print":{"date-parts":[[2022,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Severe tricuspid regurgitation (TR) is independently associated with increased morbidity and mortality. Percutaneous transcatheter approaches may offer an alternative for patients not amenable to surgery.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>TriCLASP is a prospective, single\u2010arm, multicenter European post\u2010market clinical follow\u2010up study (NCT04614402) to evaluate the safety and performance of the PASCAL system (Edwards Lifesciences) in patients with severe or greater TR. At 30 days, a composite of major adverse events (MAEs) adjudicated by a clinical events committee, echocardiographic parameters adjudicated by core laboratory, and clinical, functional, and quality\u2010of\u2010life measures were evaluated.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Mean age of the 74 enrolled patients was 80.3 years, with 58.1% female, 90.5% systemic hypertension, and 77.0% in New York Heart Association\u00a0(NYHA) class III\/IV. Mean Society for Thoracic Surgeons score (MV repair) was 9.0%. TR severity was significantly reduced at discharge (<jats:italic>p<\/jats:italic>\u2009&lt;\u20090.001) and sustained at 30 days (<jats:italic>p<\/jats:italic>\u2009&lt;\u20090.001), and 90.0% of patients achieved \u2264moderate TR. The composite MAE rate at 30 days was 3.0%, including 4 events in 2 patients: cardiovascular mortality 1.5%, stroke 1.5%, renal complications requiring unplanned dialysis or renal replacement therapy 1.5%, and severe bleeding 1.5%. There were no nonelective tricuspid valve reinterventions, major access site and vascular complications, major cardiac structural complications, or device embolizations. NYHA class I\/II was achieved in 55.8%, 6\u2010minute walk distance\u00a0improved by 38.2\u2009m (<jats:italic>p<\/jats:italic>\u2009&lt;\u20090.001), and Kansas City cardiomyopathy questionnaire\u00a0scores improved by 13.4 points (<jats:italic>p<\/jats:italic>\u2009&lt;\u20090.001).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Experience with the PASCAL transcatheter valve repair system in a European post\u2010market setting confirms favorable safety and effectiveness at 30 days. TR significantly reduced, and clinical, functional, and quality\u2010of\u2010life outcomes significantly improved. This study is ongoing.\u00a0Clinical Trial Registration: The study is ongoing and registered on <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"http:\/\/ClinicalTrials.gov\">ClinicalTrials.gov<\/jats:ext-link> as NCT04614402. The current analysis is an interim report.<\/jats:p><\/jats:sec>","DOI":"10.1002\/ccd.30450","type":"journal-article","created":{"date-parts":[[2022,11,15]],"date-time":"2022-11-15T18:33:10Z","timestamp":1668537190000},"page":"1291-1299","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":26,"title":["Transcatheter valve repair of tricuspid regurgitation with the PASCAL system: TriCLASP study 30\u2010day results"],"prefix":"10.1002","volume":"100","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8259-1737","authenticated-orcid":false,"given":"Stephan","family":"Baldus","sequence":"first","affiliation":[{"name":"Department of Cardiology, Heart Center University Hospital Cologne Cologne Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5190-813X","authenticated-orcid":false,"given":"Niklas","family":"Schofer","sequence":"additional","affiliation":[{"name":"Department of Cardiology, University Heart &amp; Vascular Center Hamburg University Medical Center Hamburg\u2010Eppendorf Hamburg Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J\u00f6rg","family":"Hausleiter","sequence":"additional","affiliation":[{"name":"Medizinische Klinik und Poliklinik M\u00fcnchen Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kai","family":"Friedrichs","sequence":"additional","affiliation":[{"name":"Herz\u2010 und Diabeteszentrum NRW Bad Oeynhausen Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"P.","family":"Lurz","sequence":"additional","affiliation":[{"name":"Herzzentrum Leipzig Leipzig Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Philipp","family":"Luedike","sequence":"additional","affiliation":[{"name":"Department of Cardiology and Vascular Medicine, West German Heart and Vascular Center University Hospital Essen Essen Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christian","family":"Frerker","sequence":"additional","affiliation":[{"name":"Universitaetsklinikum Schleswig Holstein Campus Lubeck Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"G.","family":"Nickenig","sequence":"additional","affiliation":[{"name":"Universit\u00e4tsklinikum Bonn Bonn Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Edith","family":"Lubos","sequence":"additional","affiliation":[{"name":"Katholisches Marienkrankenhaus Hamburg Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roman","family":"Pfister","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Heart Center University Hospital Cologne Cologne Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M. I.","family":"K\u00f6rber","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Heart Center University Hospital Cologne Cologne Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel","family":"Kalbacher","sequence":"additional","affiliation":[{"name":"Department of Cardiology, University Heart &amp; Vascular Center Hamburg University Medical Center Hamburg\u2010Eppendorf Hamburg Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"N\u00e4bauer","sequence":"additional","affiliation":[{"name":"Medizinische Klinik und Poliklinik M\u00fcnchen Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"C.","family":"Besler","sequence":"additional","affiliation":[{"name":"Herzzentrum Leipzig Leipzig Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2336-7991","authenticated-orcid":false,"given":"Amir Abbas","family":"Mahabadi","sequence":"additional","affiliation":[{"name":"Department of Cardiology and Vascular Medicine, West German Heart and Vascular Center University Hospital Essen Essen Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marcel","family":"Weber","sequence":"additional","affiliation":[{"name":"Universit\u00e4tsklinikum Bonn Bonn Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M.","family":"Zdanyte","sequence":"additional","affiliation":[{"name":"University Hospital T\u00fcbingen T\u00fcbingen Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"C. 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