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

Aortic Valve Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05044377
• Other study ID #: high-risk AS 2020-08
• Status: Recruiting
• Start date: July 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: September 2021
• Source: China National Center for Cardiovascular Diseases
• Contact: zhe Li, doctor
• Phone: +86 13511031654
• Email: ada521521[@]126.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 540
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

Inclusion Criteria:

• • patients over 75 years old meet one of the following conditions. severe valvular heart disease as defined by echocardiography:

1. aortic stenosis, moderate or above, or valve area =1.0cm2, or maximal jet velocity =4.0m/sec, or mean pressure gradient =40mmHg,

2. aortic regurgitation, moderate or above, or jet width =65% of left ventricular outflow tract, or regurgitant volume=60ml/beat, or regurgitant fraction =50%,

Exclusion Criteria:

• • Patients cannot be followed up for any reasons.

• •Patients have been enrolled in this study

Related Conditions & MeSH terms

• Aortic Valve Disease
• Heart Defects, Congenital
• Heart Valve Diseases

Locations

Country	Name	City	State
China	Fuwai hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Yongjian Wu

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	all-cause mortality	The primary endpoint of this study is 1 years all-cause mortality all stroke and re-hospitalization (for valve-related decompensation or procedure-related complications) .	1 year