JenaValve, maker of the Trilogy transcatheter heart valve (THV) system, released results from its ALIGN-AP pivotal trial for Trilogy in high-risk patients with symptomatic, severe aortic regurgitation (AR) at this year’s Transcatheter Cardiovascular Therapeutics (TCT) annual scientific symposium.

Trilogy经导管心脏瓣膜（THV）系统制造商JenaValve在今年的经导管心血管治疗（TCT）年度科学研讨会上发布了ALIGN-AP针对有症状，严重主动脉瓣关闭不全（AR）高危患者Trilogy关键试验的结果。

The investigators concluded Trilogy THV performance was “excellent” with large EOA and low transvalvular gradients as well as low paravalvular regurgitation. The company said echocardiography showed “significant improvement” in LV remodeling, and patients reported sustained improvement in quality of life and heart failure functional status through one year. .

研究人员得出结论，Trilogy THV表现“极好”，具有较大的EOA和较低的跨瓣梯度以及较低的瓣周返流。该公司表示，超声心动图显示LV重塑“显着改善”，患者报告生活质量和心力衰竭功能状态持续改善一年。。.

“We are incredibly pleased to share the ALIGN-AR results, which demonstrate safety and efficacy as well as exceptional technical performance and reversal of heart enlargement with the Trilogy THV system,” JenaValve’s chief medical officer Dr. Duane Pinto told the press. “We would especially like to thank the ALIGN-AR investigators and site participants for their tremendous work and impact for patients with aortic regurgitation.” .

JenaValve首席医疗官Duane Pinto博士向新闻界表示：“我们非常高兴地分享ALIGN-AR结果，这些结果证明了Trilogy THV系统的安全性和有效性，以及卓越的技术性能和心脏扩大的逆转。”。“我们特别要感谢ALIGN-AR研究人员和现场参与者为主动脉瓣关闭不全患者所做的巨大工作和影响。”。.

“We are encouraged to see the significant LV mass reduction at over 20% and substantial improvement in quality of life in the ALIGN-AR pivotal trial results,” added Torsten P. Vahl, MD, Principal Investigator of the ALIGN-AR trial. “Pending U.S. regulatory approval, we look forward to being able to offer the Trilogy THV System to our patients with ssAR.” .

ALIGN-AR试验首席研究员Torsten P.Vahl博士补充说：“在ALIGN-AR关键试验结果中，我们鼓励看到LV质量显着降低超过20%，生活质量显着改善。”。“在美国监管部门批准之前，我们期待能够为ssAR患者提供Trilogy THV系统。”。.

Results from the study aim to support a premarket approval submission to the U.S. Food and Drug Administration (FDA). If approved, JenaValve says Trilogy THV would become the first, only transcatheter aortic valve replacement (TAVR) system in the U.S. indicated for treatment of symptomatic, severe AR.

该研究的结果旨在支持向美国食品和药物管理局（FDA）提交上市前批准。如果获得批准，JenaValve说Trilogy THV将成为美国第一个也是唯一一个用于治疗症状性严重AR的经导管主动脉瓣置换术（TAVR）系统。

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