{"doi":"10.1016/j.jcin.2022.09.005","title":"Randomized Comparison of Transcatheter Edge-to-Edge Repair for Degenerative Mitral Regurgitation in Prohibitive Surgical Risk Patients","abstract":null,"journal":"JACC: Cardiovascular Interventions","year":2022,"id":638917,"datarank":0.750591945891819,"base_score":5.003946305945459,"endowment":5.003946305945459,"self_citation_contribution":0.750591945891819,"citation_network_contribution":0.0,"self_endowment_contribution":0.750591945891819,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":148,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":null,"is_data_producer":false,"deposit_databanks":null,"is_oa":false,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":null,"fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":326994,"name":"Robert L. Smith","orcid":"0000-0001-6789-7076","position":1,"is_corresponding":false},{"id":697124,"name":"Linda D. Gillam","orcid":"0000-0002-1716-7574","position":2,"is_corresponding":false},{"id":736146,"name":"Firas Zahr","orcid":"0000-0001-8448-8880","position":3,"is_corresponding":false},{"id":1659737,"name":"Scott Chadderdon","orcid":null,"position":4,"is_corresponding":false},{"id":526932,"name":"Raj Makkar","orcid":"0000-0002-6613-519X","position":5,"is_corresponding":false},{"id":1659738,"name":"Ralph Stephan von Bardeleben","orcid":"0000-0002-1356-0037","position":6,"is_corresponding":false},{"id":1659739,"name":"Robert M. Kipperman","orcid":null,"position":7,"is_corresponding":false},{"id":1659740,"name":"Andrew N. Rassi","orcid":null,"position":8,"is_corresponding":false},{"id":922691,"name":"Molly Szerlip","orcid":"0000-0002-4907-1825","position":9,"is_corresponding":false},{"id":1174400,"name":"Scott Goldman","orcid":null,"position":10,"is_corresponding":false},{"id":1659741,"name":"Ignacio Inglessis-Azuaje","orcid":null,"position":11,"is_corresponding":false},{"id":666887,"name":"Pradeep Yadav","orcid":"0000-0003-1278-9136","position":12,"is_corresponding":false},{"id":767235,"name":"Philipp Lurz","orcid":"0000-0002-5993-4487","position":13,"is_corresponding":false},{"id":1030778,"name":"Charles J. Davidson","orcid":"0000-0003-0783-9995","position":14,"is_corresponding":false},{"id":1659745,"name":"Mubashir Mumtaz","orcid":null,"position":15,"is_corresponding":false},{"id":1659746,"name":"Hemal Gada","orcid":null,"position":16,"is_corresponding":false},{"id":773738,"name":"Saibal Kar","orcid":"0000-0003-1547-4869","position":17,"is_corresponding":false},{"id":1659747,"name":"Susheel K. Kodali","orcid":null,"position":18,"is_corresponding":false},{"id":1659748,"name":"Roger Laham","orcid":null,"position":19,"is_corresponding":false},{"id":763669,"name":"William Hiesinger","orcid":"0000-0002-3548-2578","position":20,"is_corresponding":false},{"id":1659749,"name":"Neil P. Fam","orcid":null,"position":21,"is_corresponding":false},{"id":1659750,"name":"Mirjam Keßler","orcid":null,"position":22,"is_corresponding":false},{"id":275866,"name":"William W. 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Morse","orcid":"0000-0002-5725-4533","position":30,"is_corresponding":false},{"id":1659751,"name":"Niklas Schofer","orcid":null,"position":31,"is_corresponding":false},{"id":1659752,"name":"Sameer Gafoor","orcid":null,"position":32,"is_corresponding":false},{"id":457662,"name":"Azeem Latib","orcid":"0000-0001-9035-343X","position":33,"is_corresponding":false},{"id":865702,"name":"Konstantinos Koulogiannis","orcid":"0000-0002-5889-0865","position":34,"is_corresponding":false},{"id":1659753,"name":"Leo Marcoff","orcid":null,"position":35,"is_corresponding":false},{"id":636863,"name":"Jörg Hausleiter","orcid":"0000-0003-2909-7961","position":36,"is_corresponding":false},{"id":773739,"name":"D. Scott Lim","orcid":"0000-0001-6951-6660","position":0,"is_corresponding":false}],"reference_count":0,"raw_metadata":{"has_enrichment":true,"resolved":true,"title":"Randomized Comparison of Transcatheter Edge-to-Edge Repair for Degenerative Mitral Regurgitation in Prohibitive Surgical Risk Patients","abstract":"BACKGROUND: Severe symptomatic degenerative mitral regurgitation (DMR) has a poor prognosis in the absence of treatment, and new transcatheter options are emerging.\nOBJECTIVES: The CLASP IID (Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial) randomized trial (NCT03706833) is the first to evaluate the safety and effectiveness of the PASCAL system compared with the MitraClip system in patients with significant symptomatic DMR. This report presents the primary safety and effectiveness endpoints for the trial.\nMETHODS: Patients with 3+ or 4+ DMR at prohibitive surgical risk were assessed by a central screening committee and randomized 2:1 (PASCAL:MitraClip). Study oversight also included an echocardiography core laboratory and a clinical events committee. The primary safety endpoint was the composite major adverse event rate at 30 days. The primary effectiveness endpoint was the proportion of patients with mitral regurgitation (MR) ≤2+ at 6 months.\nRESULTS: A prespecified interim analysis in 180 patients demonstrated noninferiority of the PASCAL system vs the MitraClip system for the primary safety and effectiveness endpoints of major adverse event rate (3.4% vs 4.8%) and MR ≤2+ (96.5% vs 96.8%), respectively. Functional and quality-of-life outcomes significantly improved in both groups (P < 0.05). The proportion of patients with MR ≤1+ was durable in the PASCAL group from discharge to 6 months (PASCAL, 87.2% and 83.7% [P = 0.317 vs discharge]; MitraClip, 88.5% and 71.2% [P = 0.003 vs discharge]).\nCONCLUSIONS: The CLASP IID trial demonstrated safety and effectiveness of the PASCAL system and met noninferiority endpoints, expanding transcatheter treatment options for prohibitive surgical risk patients with significant symptomatic DMR.","is_dataset_classified":null,"base_score":5.003946305945459,"endowment":5.003946305945459,"datacite_reuse_total":0,"file_count":0,"downloads":0,"views":0,"has_version_chain":false,"is_dataset":false,"is_oa":false,"pmid":"36121247","pmcid":null,"openalex_id":"https://openalex.org/W4296160358","authors":[],"funders":[],"total_grants":0,"fwci":20.7604,"citation_percentile":0.99713673,"influential_citations":0,"citation_trend":[{"year":2022,"count":4},{"year":2023,"count":55},{"year":2024,"count":36},{"year":2025,"count":40},{"year":2026,"count":13}],"oa_status":"bronze","license":"http://www.elsevier.com/open-access/userlicense/1.0/","oa_locations":[{"url":"https://www.sciencedirect.com/science/article/pii/S1936879822017046/pdf","host_type":"journal"},{"url":"https://www.sciencedirect.com/science/article/pii/S1936879822017046/pdf","host_type":"publisher"},{"url":"https://api.elsevier.com/content/article/PII:S1936879822017046?httpAccept=text/xml","host_type":"publisher"},{"url":"https://api.elsevier.com/content/article/PII:S1936879822017046?httpAccept=text/plain","host_type":"publisher"},{"url":"https://doi.org/10.1016/j.jcin.2022.09.005","host_type":"journal"},{"url":"https://pubmed.ncbi.nlm.nih.gov/36121247","host_type":"repository"}],"fields_of_study":["Cardiac Valve Diseases and Treatments","Cardiovascular Function and Risk Factors","Cardiac and Coronary Surgery Techniques","Humans","Cardiac Catheterization","Heart Valve Prosthesis Implantation","Mitral Valve","Mitral Valve Insufficiency","Quality of Life","Treatment Outcome"],"mesh_terms":["Cardiac Catheterization","Humans","Mitral Valve","Mitral Valve Insufficiency","Quality of Life","Treatment Outcome","Heart Valve Prosthesis Implantation"],"keywords":["Medicine","MitraClip","Clinical endpoint","Adverse effect","Randomized controlled trial","Mitral regurgitation","Surgery","Pascal (unit)","Internal medicine","Cardiology","CLASP IID","M-TEER","MitraClip system","PASCAL system","TMVr","mitral valve transcatheter edge-to-edge repair","transcatheter mitral valve repair"],"sdg_mappings":[],"linked_datasets":[],"clinical_trials":[],"software_tools":[],"database_accessions":[],"source":"live","citation_network_status":"fetched"},"created_at":"2026-08-06T21:54:51.620748Z","pmid":null,"pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}