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Endpoints for tricuspid regurgitation trans-catheter therapy trials.
Progress in Cardiovascular Diseases ( IF 5.6 ) Pub Date : 2019-12-02 , DOI: 10.1016/j.pcad.2019.11.019
Rebecca T Hahn 1 , Ori Ben-Yehuda 1 , Martin B Leon 1
Affiliation  

Tricuspid regurgitation (TR), particularly functional or secondary TR, is increasingly recognized in clinical practice and when at least moderate in severity is associated with significant increase in mortality. In recent years multiple new trans-catheter devices have been developed to treat tricuspid regurgitation and are now undergoing clinical trial evaluations. The choice of appropriate endpoints in TR trials is particularly challenging as the disease is complex, often co-exists with left heart disease and pulmonary hypertension, and has not been extensively studied. Endpoints utilized in left heart disease trials have been applied with success to TR trials, and innovative trial designs will allow the initiation of pivotal randomized trials. Ultimately the development of TR specific endpoints may provide for more specific and robust assessment of these novel therapies.

中文翻译:

三尖瓣返流经导管治疗试验的终点。

三尖瓣关闭不全(TR),特别是功能性或继发性TR,在临床实践中越来越被认可,并且当严重程度至少为中度与死亡率显着增加有关时。近年来,已经开发出多种新的经导管设备来治疗三尖瓣关闭不全,目前正在进行临床试验评估。在TR试验中选择合适的终点特别具有挑战性,因为该疾病很复杂,通常与左心疾病和肺动脉高压并存,并且尚未得到广泛研究。左心疾病试验中使用的终点已成功应用于TR试验,创新的试验设计将允许开展关键的随机试验。
更新日期:2019-12-02
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