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

NCT ID: NCT05044377

Last Updated: 2021-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

540 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-01

Study Completion Date

2022-12-31

Brief Summary

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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

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Conditions

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Aortic Valve Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yongjian Wu

OTHER_GOV

Sponsor Role lead

Responsible Party

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Yongjian Wu

Chief physician

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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yongjian wu, doctor

Role: STUDY_CHAIR

Fuwai Hospital, National Center for Cardiovascular Diseases,Chinese Academy of Medical Sciences

Locations

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Fuwai hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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zhe Li, doctor

Role: CONTACT

+86 13511031654

Facility Contacts

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Yongjian Wu, M.D, Ph.D

Role: primary

0086-10-88396780

Other Identifiers

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high-risk AS 2020-08

Identifier Type: -

Identifier Source: org_study_id

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