Transfemoral transcatheter aortic valve replacement with VitaFlow TM valve for pure native aortic regurgitation in patients with high surgical risk: Rationale and design of a prospective, multicenter, and randomized SEASON-AR trial
Previous studies primarily demonstrated that transfemoral transcatheter aortic valve replacement (TAVR) with self-expanding valve appeared to be a safe and feasible treatment for patients with pure native aortic regurgitation (AR). However, the routine application of transfemoral TAVR for pure AR pa...
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creator | Zhang, Juan Kong, Xiang-Quan Gao, Xiao-Fei Chen, Jing Chen, Xiang Li, Bo Shao, Yi-Bing Wang, Yan Jiang, Hong Zhu, Jian-Cheng Zhang, Jun-Jie Chen, Shao-Liang |
description | Previous studies primarily demonstrated that transfemoral transcatheter aortic valve replacement (TAVR) with self-expanding valve appeared to be a safe and feasible treatment for patients with pure native aortic regurgitation (AR). However, the routine application of transfemoral TAVR for pure AR patients lacks support from randomized trials.
SEASON-AR trial is a prospective, multicenter, randomized, controlled, parallel-group, open-label trial, involving at least 20 sites in China, aiming to enroll 210 patients with pure native severe AR and high surgical risk. All enrolled patients are randomly assigned in a 1:1 fashion to undergo transfemoral TAVR with VitaFlow
valve and receive guideline-directed medical therapy (GDMT) or to receive GDMT alone. The primary endpoint is the rate of major adverse cardiac events (MACE) at 12 months after the procedure, defined by the composite of all-cause mortality, disabling stroke, and rehospitalization for heart failure. The major secondary endpoints encompass various measures, including procedure-related complications, device success, 6-minute walk distance, and the occurrence of each individual component of the primary endpoint. After hospital discharge, follow-up was conducted through clinical visits or telephone contact at 1, 6, and 12 months. The follow-up will continue annually until 5 years after the index procedure to assess the long-term outcomes.
SEASON-AR trial is the first study designed to investigate the clinical efficacy and safety of transfemoral TAVR with a self-expanding valve in patients with pure native severe AR with inoperable or high-risk, as compared to medical treatment only. |
doi_str_mv | 10.1016/j.ahj.2024.02.022 |
format | Article |
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SEASON-AR trial is a prospective, multicenter, randomized, controlled, parallel-group, open-label trial, involving at least 20 sites in China, aiming to enroll 210 patients with pure native severe AR and high surgical risk. All enrolled patients are randomly assigned in a 1:1 fashion to undergo transfemoral TAVR with VitaFlow
valve and receive guideline-directed medical therapy (GDMT) or to receive GDMT alone. The primary endpoint is the rate of major adverse cardiac events (MACE) at 12 months after the procedure, defined by the composite of all-cause mortality, disabling stroke, and rehospitalization for heart failure. The major secondary endpoints encompass various measures, including procedure-related complications, device success, 6-minute walk distance, and the occurrence of each individual component of the primary endpoint. After hospital discharge, follow-up was conducted through clinical visits or telephone contact at 1, 6, and 12 months. The follow-up will continue annually until 5 years after the index procedure to assess the long-term outcomes.
SEASON-AR trial is the first study designed to investigate the clinical efficacy and safety of transfemoral TAVR with a self-expanding valve in patients with pure native severe AR with inoperable or high-risk, as compared to medical treatment only.</description><identifier>ISSN: 0002-8703</identifier><identifier>EISSN: 1097-6744</identifier><identifier>DOI: 10.1016/j.ahj.2024.02.022</identifier><identifier>PMID: 38412895</identifier><language>eng</language><publisher>United States: Elsevier Limited</publisher><subject>Aged ; Aorta ; Aortic valve ; Aortic Valve - surgery ; Aortic Valve Insufficiency - epidemiology ; Aortic Valve Insufficiency - surgery ; China - epidemiology ; Clinical trials ; Congestive heart failure ; Data analysis ; Data collection ; Female ; Femoral Artery ; Health services ; Heart failure ; Heart rate ; Heart Valve Prosthesis ; Heart valves ; Humans ; Hypotheses ; Male ; Medical treatment ; Mortality ; Multicenter Studies as Topic ; Patients ; Polyethylene terephthalate ; Postoperative Complications - epidemiology ; Postoperative Complications - prevention & control ; Prospective Studies ; Prosthesis Design ; Randomized Controlled Trials as Topic ; Regurgitation ; Risk ; Stroke - epidemiology ; Stroke - etiology ; Stroke - prevention & control ; Surgeons ; Surgery ; Tomography ; Transcatheter Aortic Valve Replacement - methods ; Treatment Outcome</subject><ispartof>The American heart journal, 2024-05, Vol.271, p.76</ispartof><rights>Copyright © 2024 Elsevier Inc. All rights reserved.</rights><rights>2024. Elsevier Inc.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27901,27902</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/38412895$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Zhang, Juan</creatorcontrib><creatorcontrib>Kong, Xiang-Quan</creatorcontrib><creatorcontrib>Gao, Xiao-Fei</creatorcontrib><creatorcontrib>Chen, Jing</creatorcontrib><creatorcontrib>Chen, Xiang</creatorcontrib><creatorcontrib>Li, Bo</creatorcontrib><creatorcontrib>Shao, Yi-Bing</creatorcontrib><creatorcontrib>Wang, Yan</creatorcontrib><creatorcontrib>Jiang, Hong</creatorcontrib><creatorcontrib>Zhu, Jian-Cheng</creatorcontrib><creatorcontrib>Zhang, Jun-Jie</creatorcontrib><creatorcontrib>Chen, Shao-Liang</creatorcontrib><creatorcontrib>SEASON-AR investigators</creatorcontrib><title>Transfemoral transcatheter aortic valve replacement with VitaFlow TM valve for pure native aortic regurgitation in patients with high surgical risk: Rationale and design of a prospective, multicenter, and randomized SEASON-AR trial</title><title>The American heart journal</title><addtitle>Am Heart J</addtitle><description>Previous studies primarily demonstrated that transfemoral transcatheter aortic valve replacement (TAVR) with self-expanding valve appeared to be a safe and feasible treatment for patients with pure native aortic regurgitation (AR). However, the routine application of transfemoral TAVR for pure AR patients lacks support from randomized trials.
SEASON-AR trial is a prospective, multicenter, randomized, controlled, parallel-group, open-label trial, involving at least 20 sites in China, aiming to enroll 210 patients with pure native severe AR and high surgical risk. All enrolled patients are randomly assigned in a 1:1 fashion to undergo transfemoral TAVR with VitaFlow
valve and receive guideline-directed medical therapy (GDMT) or to receive GDMT alone. The primary endpoint is the rate of major adverse cardiac events (MACE) at 12 months after the procedure, defined by the composite of all-cause mortality, disabling stroke, and rehospitalization for heart failure. The major secondary endpoints encompass various measures, including procedure-related complications, device success, 6-minute walk distance, and the occurrence of each individual component of the primary endpoint. After hospital discharge, follow-up was conducted through clinical visits or telephone contact at 1, 6, and 12 months. The follow-up will continue annually until 5 years after the index procedure to assess the long-term outcomes.
SEASON-AR trial is the first study designed to investigate the clinical efficacy and safety of transfemoral TAVR with a self-expanding valve in patients with pure native severe AR with inoperable or high-risk, as compared to medical treatment only.</description><subject>Aged</subject><subject>Aorta</subject><subject>Aortic valve</subject><subject>Aortic Valve - surgery</subject><subject>Aortic Valve Insufficiency - epidemiology</subject><subject>Aortic Valve Insufficiency - surgery</subject><subject>China - epidemiology</subject><subject>Clinical trials</subject><subject>Congestive heart failure</subject><subject>Data analysis</subject><subject>Data collection</subject><subject>Female</subject><subject>Femoral Artery</subject><subject>Health services</subject><subject>Heart failure</subject><subject>Heart rate</subject><subject>Heart Valve Prosthesis</subject><subject>Heart valves</subject><subject>Humans</subject><subject>Hypotheses</subject><subject>Male</subject><subject>Medical treatment</subject><subject>Mortality</subject><subject>Multicenter Studies as Topic</subject><subject>Patients</subject><subject>Polyethylene terephthalate</subject><subject>Postoperative Complications - epidemiology</subject><subject>Postoperative Complications - prevention & control</subject><subject>Prospective Studies</subject><subject>Prosthesis Design</subject><subject>Randomized Controlled Trials as Topic</subject><subject>Regurgitation</subject><subject>Risk</subject><subject>Stroke - epidemiology</subject><subject>Stroke - etiology</subject><subject>Stroke - prevention & control</subject><subject>Surgeons</subject><subject>Surgery</subject><subject>Tomography</subject><subject>Transcatheter Aortic Valve Replacement - methods</subject><subject>Treatment Outcome</subject><issn>0002-8703</issn><issn>1097-6744</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>8G5</sourceid><sourceid>BENPR</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNo1kd9qFDEUh4Modq0-gDdywNvOmv-Z8W4prQrVQrt4u2STzE7WmcmYZFraF_Y1zLZbOJD84Mt3ziEIfSR4STCRX_ZL3e2XFFO-xLQUfYUWBDeqkorz12iBMaZVrTA7Qe9S2pcoaS3fohNWc0LrRizQv3XUY2rdEKLuIR-C0blz2UXQIWZv4E73dw6im3pt3ODGDPc-d_DbZ33Zh3tY_zwibYgwzdHBqLMv-fg-ut0cd4XOPozgR5jKrWjSs6fzuw7SgTBlgujTn69w88TqvjhGC9YlvxshtKBhiiFNzhz8ZzDMfWlQVC6ePZFlfBsG_-gs3F6sbq9_VaubspTX_Xv0ptV9ch-O5ylaX16sz79XV9fffpyvrqpJEFFpriQnREpDeCnJaksF01sjuKpt3ShjJW1baWrRNLYlfEsUpsyKhjvauJados_P2jLn39mlvNmHOZZN0oZhzpQSRIlCfTpS83ZwdjNFP-j4sHn5FvYfPO2Urg</recordid><startdate>202405</startdate><enddate>202405</enddate><creator>Zhang, Juan</creator><creator>Kong, Xiang-Quan</creator><creator>Gao, Xiao-Fei</creator><creator>Chen, Jing</creator><creator>Chen, Xiang</creator><creator>Li, Bo</creator><creator>Shao, Yi-Bing</creator><creator>Wang, Yan</creator><creator>Jiang, Hong</creator><creator>Zhu, Jian-Cheng</creator><creator>Zhang, Jun-Jie</creator><creator>Chen, Shao-Liang</creator><general>Elsevier Limited</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>3V.</scope><scope>7QO</scope><scope>7RV</scope><scope>7TS</scope><scope>7X7</scope><scope>7XB</scope><scope>88C</scope><scope>88E</scope><scope>8AO</scope><scope>8C1</scope><scope>8FD</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8G5</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AN0</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FR3</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M0T</scope><scope>M1P</scope><scope>M2O</scope><scope>MBDVC</scope><scope>NAPCQ</scope><scope>P64</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>Q9U</scope></search><sort><creationdate>202405</creationdate><title>Transfemoral transcatheter aortic valve replacement with VitaFlow TM valve for pure native aortic regurgitation in patients with high surgical risk: Rationale and design of a prospective, multicenter, and randomized SEASON-AR trial</title><author>Zhang, Juan ; Kong, Xiang-Quan ; Gao, Xiao-Fei ; Chen, Jing ; Chen, Xiang ; Li, Bo ; Shao, Yi-Bing ; Wang, Yan ; Jiang, Hong ; Zhu, Jian-Cheng ; Zhang, Jun-Jie ; Chen, Shao-Liang</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-p515-a47641166c14c14638d253abc5478d897cd62ff6c8599df14b17023d594e29ef3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>Aged</topic><topic>Aorta</topic><topic>Aortic valve</topic><topic>Aortic Valve - surgery</topic><topic>Aortic Valve Insufficiency - epidemiology</topic><topic>Aortic Valve Insufficiency - surgery</topic><topic>China - epidemiology</topic><topic>Clinical trials</topic><topic>Congestive heart failure</topic><topic>Data analysis</topic><topic>Data collection</topic><topic>Female</topic><topic>Femoral Artery</topic><topic>Health services</topic><topic>Heart failure</topic><topic>Heart rate</topic><topic>Heart Valve Prosthesis</topic><topic>Heart valves</topic><topic>Humans</topic><topic>Hypotheses</topic><topic>Male</topic><topic>Medical treatment</topic><topic>Mortality</topic><topic>Multicenter Studies as Topic</topic><topic>Patients</topic><topic>Polyethylene terephthalate</topic><topic>Postoperative Complications - epidemiology</topic><topic>Postoperative Complications - prevention & control</topic><topic>Prospective Studies</topic><topic>Prosthesis Design</topic><topic>Randomized Controlled Trials as Topic</topic><topic>Regurgitation</topic><topic>Risk</topic><topic>Stroke - epidemiology</topic><topic>Stroke - etiology</topic><topic>Stroke - prevention & control</topic><topic>Surgeons</topic><topic>Surgery</topic><topic>Tomography</topic><topic>Transcatheter Aortic Valve Replacement - methods</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Zhang, Juan</creatorcontrib><creatorcontrib>Kong, Xiang-Quan</creatorcontrib><creatorcontrib>Gao, Xiao-Fei</creatorcontrib><creatorcontrib>Chen, Jing</creatorcontrib><creatorcontrib>Chen, Xiang</creatorcontrib><creatorcontrib>Li, Bo</creatorcontrib><creatorcontrib>Shao, Yi-Bing</creatorcontrib><creatorcontrib>Wang, Yan</creatorcontrib><creatorcontrib>Jiang, Hong</creatorcontrib><creatorcontrib>Zhu, Jian-Cheng</creatorcontrib><creatorcontrib>Zhang, Jun-Jie</creatorcontrib><creatorcontrib>Chen, Shao-Liang</creatorcontrib><creatorcontrib>SEASON-AR investigators</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>ProQuest Central (Corporate)</collection><collection>Biotechnology Research Abstracts</collection><collection>Nursing & Allied Health Database</collection><collection>Physical Education Index</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Healthcare Administration Database (Alumni)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Public Health Database</collection><collection>Technology Research Database</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>Research Library (Alumni Edition)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>British Nursing Database</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Engineering Research Database</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>Research Library Prep</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Healthcare Administration Database</collection><collection>Medical Database</collection><collection>Research Library</collection><collection>Research Library (Corporate)</collection><collection>Nursing & Allied Health Premium</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>ProQuest Central Basic</collection><jtitle>The American heart journal</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Zhang, Juan</au><au>Kong, Xiang-Quan</au><au>Gao, Xiao-Fei</au><au>Chen, Jing</au><au>Chen, Xiang</au><au>Li, Bo</au><au>Shao, Yi-Bing</au><au>Wang, Yan</au><au>Jiang, Hong</au><au>Zhu, Jian-Cheng</au><au>Zhang, Jun-Jie</au><au>Chen, Shao-Liang</au><aucorp>SEASON-AR investigators</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Transfemoral transcatheter aortic valve replacement with VitaFlow TM valve for pure native aortic regurgitation in patients with high surgical risk: Rationale and design of a prospective, multicenter, and randomized SEASON-AR trial</atitle><jtitle>The American heart journal</jtitle><addtitle>Am Heart J</addtitle><date>2024-05</date><risdate>2024</risdate><volume>271</volume><spage>76</spage><pages>76-</pages><issn>0002-8703</issn><eissn>1097-6744</eissn><abstract>Previous studies primarily demonstrated that transfemoral transcatheter aortic valve replacement (TAVR) with self-expanding valve appeared to be a safe and feasible treatment for patients with pure native aortic regurgitation (AR). However, the routine application of transfemoral TAVR for pure AR patients lacks support from randomized trials.
SEASON-AR trial is a prospective, multicenter, randomized, controlled, parallel-group, open-label trial, involving at least 20 sites in China, aiming to enroll 210 patients with pure native severe AR and high surgical risk. All enrolled patients are randomly assigned in a 1:1 fashion to undergo transfemoral TAVR with VitaFlow
valve and receive guideline-directed medical therapy (GDMT) or to receive GDMT alone. The primary endpoint is the rate of major adverse cardiac events (MACE) at 12 months after the procedure, defined by the composite of all-cause mortality, disabling stroke, and rehospitalization for heart failure. The major secondary endpoints encompass various measures, including procedure-related complications, device success, 6-minute walk distance, and the occurrence of each individual component of the primary endpoint. After hospital discharge, follow-up was conducted through clinical visits or telephone contact at 1, 6, and 12 months. The follow-up will continue annually until 5 years after the index procedure to assess the long-term outcomes.
SEASON-AR trial is the first study designed to investigate the clinical efficacy and safety of transfemoral TAVR with a self-expanding valve in patients with pure native severe AR with inoperable or high-risk, as compared to medical treatment only.</abstract><cop>United States</cop><pub>Elsevier Limited</pub><pmid>38412895</pmid><doi>10.1016/j.ahj.2024.02.022</doi></addata></record> |
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subjects | Aged Aorta Aortic valve Aortic Valve - surgery Aortic Valve Insufficiency - epidemiology Aortic Valve Insufficiency - surgery China - epidemiology Clinical trials Congestive heart failure Data analysis Data collection Female Femoral Artery Health services Heart failure Heart rate Heart Valve Prosthesis Heart valves Humans Hypotheses Male Medical treatment Mortality Multicenter Studies as Topic Patients Polyethylene terephthalate Postoperative Complications - epidemiology Postoperative Complications - prevention & control Prospective Studies Prosthesis Design Randomized Controlled Trials as Topic Regurgitation Risk Stroke - epidemiology Stroke - etiology Stroke - prevention & control Surgeons Surgery Tomography Transcatheter Aortic Valve Replacement - methods Treatment Outcome |
title | Transfemoral transcatheter aortic valve replacement with VitaFlow TM valve for pure native aortic regurgitation in patients with high surgical risk: Rationale and design of a prospective, multicenter, and randomized SEASON-AR trial |
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