Abstract | BACKGROUND: 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. TRIAL DESIGN: 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 VitaFlowTM 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. CONCLUSION: 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.
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Authors | Juan Zhang, Xiang-Quan Kong, Xiao-Fei Gao, Jing Chen, Xiang Chen, Bo Li, Yi-Bing Shao, Yan Wang, Hong Jiang, Jian-Cheng Zhu, Jun-Jie Zhang, Shao-Liang Chen, SEASON-AR investigators |
Journal | American heart journal
(Am Heart J)
Vol. 271
Pg. 76-83
(May 2024)
ISSN: 1097-6744 [Electronic] United States |
PMID | 38412895
(Publication Type: Journal Article, Randomized Controlled Trial, Multicenter Study, Research Support, Non-U.S. Gov't, Clinical Trial Protocol)
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Copyright | Copyright © 2024 Elsevier Inc. All rights reserved. |
Topics |
- Humans
- Transcatheter Aortic Valve Replacement
(methods)
- Aortic Valve Insufficiency
(surgery, epidemiology)
- Prospective Studies
- Male
- Heart Valve Prosthesis
- Female
- Aged
- Femoral Artery
- Aortic Valve
(surgery)
- Prosthesis Design
- Stroke
(prevention & control, etiology, epidemiology)
- China
(epidemiology)
- Treatment Outcome
- Postoperative Complications
(epidemiology, prevention & control)
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