Tricuspid Valve Academic Research Consortium-2 (TVARC-2): Trial Design and Endpoints
| Title: | Tricuspid Valve Academic Research Consortium-2 (TVARC-2): Trial Design and Endpoints |
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| Authors: | Davidson CJ; Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA. Electronic address: cdavidson@nm.org.; Hahn RT; Department of Cardiology, Columbia University Irving Medical Center, New York, New York, USA; Cardiovascular Research Foundation, New York, New York, USA.; Mehaffey JH; Department of Cardiovascular and Thoracic Surgery, West Virginia University, Morgantown, West Virginia, USA.; Cohen DJ; Cardiovascular Research Foundation, New York, New York, USA; Division of Cardiology, Saint Francis Hospital and Catholic Health, Roslyn, New York, USA.; Pinney SP; Mount Sinai Morningside Cardiovascular Institute, New York, New York, USA.; Arnold SV; University of Missouri - Kansas City School of Medicine, Kansas City, Missouri, USA.; Stolz L; Medizinische Klinik und Poliklinik I, Klinikum der Universität München, Munich, Germany; DZHK (German Center for Cardiovascular Research), Partner Site Munich Heart Alliance, Munich, Germany.; Lawlor MK; University of Massachusetts, Worcester, Massachusetts, USA.; Lindenfeld J; Vanderbilt Heart and Vascular Institute, Vanderbilt University Medical Center, Nashville, Tennessee, USA.; Brener MI; Department of Cardiology, Columbia University Irving Medical Center, New York, New York, USA.; Afzal AM; Baylor Scott & White The Heart Hospital, Plano, Texas, USA.; Smith RL; Baylor Scott & White The Heart Hospital, Plano, Texas, USA.; White RM; Your 3(rd) Opinion, Chapel Hill, North Carolina, USA.; Vemulapalli S; Duke University Medical Center, Durham, North Carolina, USA.; Alu MC; Cardiovascular Research Foundation, New York, New York, USA.; Cohen E; Cardiovascular Research Foundation, New York, New York, USA.; Regan K; Cardiovascular Research Foundation, New York, New York, USA.; Sannino A; Baylor Scott & White The Heart Hospital, Plano, Texas, USA; Department of Advanced Biomedical Sciences, Division of Cardiology, Frederico II University, Naples, Italy.; Elmariah S; Division of Cardiology, University of California-San Francisco, San Francisco, California, USA.; Spitzer E; Cardialysis, Rotterdam, the Netherlands; Erasmus University Medical Centre, Rotterdam, the Netherlands.; Blackstone EH; Cleveland Clinic Lerner College of Medicine of Case Western Reserve Universe University, Cleveland, Ohio, USA.; Lurz P; Heart Center Leipzig at University of Leipzig, Leipzig, Germany.; Lindman BR; Structural Heart and Valve Center, Cardiovascular Division, Vanderbilt University Medical Center, Nashville, Tennessee, USA.; Topilsky Y; Department of Cardiology, Tel Aviv Sourasky Medical Center and Sackler School of Medicine, Tel Aviv, Israel.; Baron SJ; Division of Cardiology, Massachusetts General Hospital, Boston, Massachusetts, USA; Baim Institute of Clinical Research, Boston, Massachusetts, USA.; Chadderdon S; Knight Cardiovascular Institute, Oregon Health and Science University, Portland, Oregon, USA.; Khalique OK; Division of Cardiology, Saint Francis Hospital and Catholic Health, Roslyn, New York, USA.; Tang GHL; Department of Cardiovascular Surgery, Mount Sinai Health System, New York, New York, USA.; Taramasso M; Herzzentrum Hirslanden Zürich, Zürich, Switzerland; University of Zürich, Zürich, Switzerland.; Grayburn PA; Baylor Scott and White Heart and Vascular Hospital at Plano, Plano, Texas, USA.; Badano L; Department of Medicine and Surgery, University of Milano Bicocca, Milan, Italy; Department of Cardiology, Istituto Auxologico Italiano, IRCCS, Milan, Italy.; Leipsic J; Department of Radiology and Medicine, University of British Columbia, Vancouver, British Columbia, Canada.; Windecker S; Department of Cardiology, University Cardiovascular Center, Bern University Hospital, Inselspital, Bern, Switzerland.; Redfors B; Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden.; Rodés-Cabau J; Quebec Heart and Lung Institute, Laval University, Quebec City, Canada; Clínic Barcelona, Barcelona, Spain.; Ben-Yehuda O; Sulpizio Cardiovascular Institute, University of California, San Diego, California, USA.; Ailawadi G; Frankel Cardiovascular Center, University of Michigan Health, Ann Arbor, Michigan, USA.; Mack MJ; Baylor Scott & White The Heart Hospital, Plano, Texas, USA.; Leon MB; Department of Cardiology, Columbia University Irving Medical Center, New York, New York, USA; Cardiovascular Research Foundation, New York, New York, USA.; Badhwar V; Department of Cardiovascular and Thoracic Surgery, West Virginia University, Morgantown, West Virginia, USA.; Hausleiter J; Medizinische Klinik und Poliklinik I, Klinikum der Universität München, Munich, Germany; DZHK (German Center for Cardiovascular Research), Partner Site Munich Heart Alliance, Munich, Germany. |
| Source: | Journal of the American College of Cardiology [J Am Coll Cardiol] 2026 Apr 21; Vol. 87 (15), pp. 2044-2070. Date of Electronic Publication: 2026 Apr 21. |
| Publication Type: | Journal Article; Review |
| Language: | English |
| Journal Info: | Publisher: Elsevier Biomedical Country of Publication: United States NLM ID: 8301365 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1558-3597 (Electronic) Linking ISSN: 07351097 NLM ISO Abbreviation: J Am Coll Cardiol Subsets: MEDLINE |
| Imprint Name(s): | Original Publication: [New York, N.Y.] : Elsevier Biomedical, [c1983- |
| MeSH Terms: | Tricuspid Valve Insufficiency*/surgery ; Tricuspid Valve Insufficiency*/diagnosis ; Tricuspid Valve*/surgery ; Heart Valve Prosthesis Implantation*/methods ; Research Design*; Cardiac Catheterization/methods ; Humans ; Endpoint Determination |
| Abstract: | The first Tricuspid Valve Academic Research Consortium publication standardized definitions of disease etiology and severity, as well as standardized endpoints for trials to address the knowledge gaps related to identification and management of patients with tricuspid regurgitation. Based on randomized trials comparing transcatheter tricuspid valve intervention with optimal medical therapy, transcatheter edge-to-edge repair and tricuspid valve replacement were approved by the U.S. Food and Drug Administration and received CE Mark. These technologies represent a major step forward for patients with severe symptomatic tricuspid regurgitation and transcatheter tricuspid valve intervention. This second chapter of the Tricuspid Valve Academic Research Consortium focuses on defining specific trial design and endpoint options for comparisons of emerging technologies, tricuspid valve surgery, and medical therapy.; (Copyright © 2026 The Authors. Published by Elsevier Inc. All rights reserved.) |
| Competing Interests: | Funding Support and Author Disclosures Dr Davidson has received research grant support and is an uncompensated advisor for Edwards Lifesciences; and has received research grant support from Abbott Vascular. Dr Hahn has received speaker fees from Abbott Vascular, Baylis Medical, and Edwards Lifesciences; has institutional consulting agreements for which she receives no direct compensation with Abbott Vascular, Boston Scientific, Edwards Lifescience, Medtronic, and Novartis; has equity with Navigate; and is the chief scientific officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation. Dr Cohen has received institutional research support from Abbott, Edwards Lifesciences, Boston Scientific, Philips, Corvia Medical, ZOLL Medical, CathWorks, and Ancora; and has received consulting income from Medtronic, Edwards Lifesciences, Abbott, Boston Scientific, and Elixir Medical. Dr Pinney has received consulting fees from Abbott, ADI, Ancora Heart, CareDx, Cordio, Medtronic, Procyrion, Restore Medical, Transmedics, and ValGen; and has received speaker fees from Impulse Dynamics. Dr Stolz has received speaker honoraria from Edwards Lifesciences. Dr Lindenfeld has received grants from AstraZeneca and Volumetrix; and has received consulting fees from Abbott, Abiomed, Adona, Alleviant, AskBio, Axon, Boston Scientific, CVRx, Edwards Lifesciences, Fire-1, Intershunt, Kestra Medical Technologies, Medtronic, Merck, OrchestraBiomed, V-Wave, and Whiteswell. Dr Brener is supported by 1K23HL177311-01A1; has received grant funding from Abbott Vascular and J&J/Abiomed; and has received consulting honoraria from CroiValve and Ventricord. Dr Afzal has received consultant fees/honoraria/speaker’s bureau from Abiomed, AstraZenca, and Bristol Myers Squibb. Dr Smith has received grant support from Edwards Lifesciences, Medtronic, and Artivion; has received and consultant fees/honoraria/speaker’s bureau from enableCV. Ms White has received consultant fee/honoraria/Speakers Bureau from Bard Medical, Philips, Abiomed, Abbott, ACIST, Ancora Heart, Edwards Lifesciences, Elixir, and Lymphatica; and holds equity stock/options at Natera. Dr Vemulapalli has received grant support from Abbott, Boston Scientific, Cytokinetics, and Edwards Lifesciences; and has received consultant fees from Medtronic, Boehringer Ingelheim, Veralox Therapeutics, AstraZenca, Abbott, Edwards Lifesciences, and Cytokinetics. Dr Sannino has received grant support from Edwards Lifesciences and Venus Medtech. Dr Elmariah has received institutional research grants from Abbott, Edwards Lifesciences, and Medtronic; has received speaking/consulting fees from Abbott and Edwards Lifesciences; and holds equity in Prospect Health. Dr Spitzer has received institutional contracts/grants for which he receives no direct compensation from Abbott, Biosensors Europe SA, Boston Scientific, Edwards Lifesciences, Medtronic, Mixin Medtech (Suzhou) Co, Ltd, Shanghai Microport Medical Co, Ltd, Novo Nordisk A/S, NVT GmbH Philips Healthcare, Pie Medical Imaging, Shanghai Shenqi Medical Technologies Co, Ltd, and Siemens Healthcare GmbH; and declares being a board member of Cardialysis, European Cardiovascular Research Institute, EU-MDR Cardiovascular Collaboratory, and Academic Research Consortium. Dr Blackstone has received grant support from Edwards Lifesciences. Dr Lurz has received grant support from Recor, Abbott, and Edwards Lifesciences; has received consultant fees from Innoventrics, Edwards Lifesciences, Abbott, and has Boehringer Ingelheim; and royalty/intellectual property rights from Innoventric. Dr Lindman has received investigator-initiated research grants, served as PI of the EARLY TAVR trial and PROGRESS trial biobanks, and consulted for Edward Lifesciences, Medtronic, Anteris, Kardigan, and AstraZeneca. Dr Topilsky has received consultant fees from Edwards Lifesciences and Venus Medtech. Dr Baron has received institutional contracts/grants from Abbott, Recor Medical, Acarix, Boston Scientific Corp, and Abiomed and has received speaking/consulting fees from Boston Scientific Corp, Medtronic, Edwards Lifesciences, Shockwave, Chiesi, Picardia, and ZOLL Medical. Dr Chadderdon has received consultant fees from Medtronic and Edwards Lifesciences; and has received grant support from GE Healthcare and Philips. Dr Khalique is a consultant for Edwards Lifesciences, Boston Scientific, Philips, and Siemens Healthineers. Dr Tang has received speaker's honoraria and served as a physician proctor, consultant, advisory board member, TAVR publications committee member, RESTORE study steering and screening committee member, APOLLO trial screening committee member, and IMPACT MR steering committee member for Medtronic; has received speaker's honoraria and served as a physician proctor, consultant, advisory board member, ENVISION trial screening committee member, and TRILUMINATE trial anatomic eligibility and publications committee member for Abbott Structural Heart; has served as an advisory board member for Boston Scientific; has served as a consultant for Shockwave Medical, Anteris, Philips, Edwards Lifesciences, Peija Medical, and Shenqi Medical Technology; and has received has speaker's honoraria from Siemens Healthineers. Dr Taramasso has served as a consultant for Abbott, Edwards Lifesciences, Boston Scientific, Shenqi Medical, Simulands, Occlufit, MTEx, MEDIRA, 4tech, and CoreMedic; and received fees from Cardiovalve. Dr Grayburn receives grant support from Abbott Vascular, Medtronic, Boston Scientific, Cardiovalve, Edwards Lifesciences, W. L. Gore, Medtronic, and NeoChord; and has received consulting fees from Abbott Vascular, Edwards Lifesciences, W. L. Gore, and 4C Medical. Dr Badano has received speaker honoraria from GE Healthcare and Philips Medical Systems, and research equipment from GE Healthcare, Philips Medical Systems, and EsaOte S.p.A. Dr Leipsic has received research grants from Edwards Lifesciences, Abbott, Boston Scientific, and Medtronic for CT core lab analyses in transcatheter aortic valve replacement and is a consultant for Circle CVI. Dr Windecker has received research, travel and/or educational grants to the institution from Abbott, Abiomed, Alnylam, Amicus Therapeutics, Amgen, Anteris, Astra Zeneca, Bayer, B.Braun, Bioanalytica, Biotronik, Boehringer Ingelheim, Boston Scientific, Bristol Myers Squibb, Cordis Medical, CorFlow Therapeutics, CSL Behring, Daiichi Sankyo, Edwards Lifesciences, Fumedica, GE Healthcare, Guerbet, IACULIS, Inari Medical, Janssen AI, Johnson & Johnson, Medalliance, Medtronic, MSD Merck Sharp & Dohme, Neovii Pharmaceutica, Neutromedics AG, Novartis, Novo Nordisk, OM Pharma, Optimapharm, Orchestra BioMed, Pfizer, Philips AG, Sanofi-Aventis, Servier, Shockwave Medical, Siemens Healthcare, Sinomed, SMT Sahajanand Medical Technologies, Vascular Medical, and V-Wave. Dr Redfors has received consultant fees from Pfizer and Boehringer Ingelheim. Dr Rodés-Cabau has received institutional research grants and consultant/speaker fees from Edwards Lifesciences, Medtronic, and Abbott Dr Ben-Yehuda has received consulting fees from Edwards Lifesciences, Medtronic, Cardiovalve, and Bioventrix. Dr Ailawadi is a consultant for Abbott, Edwards Lifesciences, Medtronic, Admedus, Gore, and Atricure. Dr Mack has served as the study chair for Medtronic and trial PI for Abbott and Edwards Lifesciences. Dr Leon has received institutional research support from Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott; and has received consulting/advisory board participation for Foldax, Anteris, JenaValve, Medinol, SoloPace, and Bain Capital. Dr Hausleiter is a consultant to and has received speaker honoraria and institutional research support from Edwards Lifesciences and TriCares. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. |
| Contributed Indexing: | Keywords: transcatheter tricuspid valve intervention; tricuspid regurgitation; tricuspid valve surgery |
| Entry Date(s): | Date Created: 20260422 Date Completed: 20260422 Latest Revision: 20260622 |
| Update Code: | 20260623 |
| DOI: | 10.1016/j.jacc.2026.02.5102 |
| PMID: | 42017555 |
| Database: | MEDLINE |
Journal Article; Review