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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Veröffentlicht in:The American heart journal 2024-05, Vol.271, p.76
Hauptverfasser: 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
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container_title The American heart journal
container_volume 271
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
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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. 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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 &amp; 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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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