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

Overview

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, we 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.

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 31, 2022

Clinical Trial Outcome Measures

Primary Measures

  • all-cause mortality
    • Time Frame: 1 year

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 75 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Yongjian Wu
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Yongjian Wu, Chief physician – China National Center for Cardiovascular Diseases
  • Overall Official(s)
    • yongjian wu, doctor, Study Chair, Fuwai Hospital, National Center for Cardiovascular Diseases,Chinese Academy of Medical Sciences
  • Overall Contact(s)
    • zhe Li, doctor, +86 13511031654, ada521521@126.com

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