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Clinical Trial Summary

Prospective, multicenter, randomized trial.

Clinical Trial Description

Patients with severe native aortic valve regurgitation (AR) who have symptoms, impaired LVEF (≤55%) or left ventricular enlargement have the indications for surgery. According to data from the Euro Heart Survey, only 21.8% with LVEF 30-50% and 2.7% with LVEF <30% were referred for surgical aortic valve replacement (SAVR) among patients with severe native aortic regurgitation. Advanced age and comorbidities were often considered as main reasons to refuse SAVR. The annual mortality of untreated patients with severe AR is 10-20%. Pure native AR is always an exclusion criterion in all randomized controlled trials on transcatheter aortic valve implantation (TAVR) because the specific anatomical features can preclude adequate valve implantation. Several small, retrospective studies showed that off-label use of TAVR appears to be a feasible treatment choice for AR patients at high risk for SAVR. The present study aims to investigate the use of TAVR in AR patients. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT04864145
Study type Interventional
Source Nanjing First Hospital, Nanjing Medical University
Contact Jun-Jie Zhang, MD, PhD
Phone +86-25-52271350
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date May 15, 2021
Completion date May 30, 2031

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