NCT05044377

Study on Optimal Treatment Strategy for Elderly Patients With High-risk Complex Aortic Valve Disease

Status unknown Last updated 20 September 2021

What this trial tests

trial in Aortic Valve Disease in 540 participants. Status unknown.

Timeline

1 July 2021

Primary endpoint
31 December 2022

31 December 2022

Quick facts

Lead sponsor	Yongjian Wu
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	540
Start date	1 July 2021
Primary completion	31 December 2022
Estimated completion	31 December 2022
Sites	1 location across China

Conditions studied

• Aortic Valve Disease — all drugs for Aortic Valve Disease →

Sponsor

Yongjian Wu

Who can join

75 and older, any sex, with Aortic Valve Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Aortic valve disease (AVD) is the most common and age-related mortality in elderly patients with valvular heart disease (VHD). Although transcatheter aortic valve replacement (TAVR) has been recommended at a higher level in foreign guidelines, there are still many high-risk and severe elderly patients with VHD who have not received effective treatment because of many complications and untimely medical treatment. Different from Europe and the United States, the majority of patients with bicuspid aortic valve are in China, and the calcification is more serious. The current clinical evaluation system and treatment guidelines can not be effectively applied to the high-risk and complex elderly patients. Therefore, the investigators should train and set up a valvular heart disease team, explore the technical difficulties of TAVR treatment in such patients, establish emergency TAVR operation mechanism, build a clinical evaluation system for high-risk and complex elderly patients with aortic valve disease in China, evaluate the curative effect periodically and further optimize the treatment strategy, so as to improve the quality of life and the meaning of life cycle of elderly patients with VHD in China Great significance.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Can Measuring the 'Dual Anchors of Aorta' Enhance the Success Rate of TAVR?-A Single-Center Experience.
   Chen Y, Ferdous MM, Kottu L, Zhao J, et al · · 2023 · cited 2× · PMID 36769804 · DOI 10.3390/jcm12031157
2. Anatomical features of aortic root in patients with aortic stenosis treated by TAVR: an observational study.
   Chen Y, Sun B, Wang Z, Wang M, et al · · 2025 · cited 1× · PMID 40796800 · DOI 10.1186/s12880-025-01867-y