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

Sponsor
Yongjian Wu (Other)
Overall Status
Recruiting
CT.gov ID
NCT05044377
Collaborator
(none)
540
1
18
30

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    540 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Study on Optimal Treatment Strategy for Elderly Patients With High-risk Complex Aortic Valve Disease
    Actual Study Start Date :
    Jul 1, 2021
    Anticipated Primary Completion Date :
    Dec 31, 2022
    Anticipated Study Completion Date :
    Dec 31, 2022

    Outcome Measures

    Primary Outcome Measures

    1. 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) .

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    75 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fuwai hospital Beijing Beijing China 100037

    Sponsors and Collaborators

    • Yongjian Wu

    Investigators

    • Study Chair: yongjian wu, doctor, Fuwai Hospital, National Center for Cardiovascular Diseases,Chinese Academy of Medical Sciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yongjian Wu, Chief physician, China National Center for Cardiovascular Diseases
    ClinicalTrials.gov Identifier:
    NCT05044377
    Other Study ID Numbers:
    • high-risk AS 2020-08
    First Posted:
    Sep 14, 2021
    Last Update Posted:
    Sep 20, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 20, 2021