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

• Conditions: Aortic Valve Disease

• Registration Number: NCT05044377
• Lead Sponsor: Yongjian Wu

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-01
• Status Verified: 2021-09
• Study First Submitted: 2021-09-12
• Study First Submitted QC: 2021-09-12
• Study First Posted: 2021-09-14
• Last Update Submitted: 2021-09-14
• Last Update Posted: 2021-09-20
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 540

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
all-cause mortality	1 year	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) .

Trial Locations

Locations (1)

Fuwai hospital; 🇨🇳 Beijing, Beijing, China