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

NCT05044377 | Unknown

• 1 other identifier: high-risk AS 2020-08
• Study Type: observational
• Target: 540
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Valve Disease

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Seven cooperative hospitals with cardiovascular as the key specialty in Beijing have continuously registered patients with severe aortic valve disease aged 75 years or older.

You may qualify if:

• patients over 75 years old meet one of the following conditions. severe valvular heart disease as defined by echocardiography:
• aortic stenosis, moderate or above, or valve area ≤1.0cm2, or maximal jet velocity ≥4.0m/sec, or mean pressure gradient ≥40mmHg,
• aortic regurgitation, moderate or above, or jet width ≥65% of left ventricular outflow tract, or regurgitant volume≥60ml/beat, or regurgitant fraction ≥50%,

You may not qualify if:

• Patients cannot be followed up for any reasons.
• Patients have been enrolled in this study

Sponsors & Collaborators

• Yongjian Wu: lead

Study Sites (1)

Fuwai hospital

Beijing, Beijing Municipality, 100037, China

RECRUITING

MeSH Terms

Conditions

Aortic Valve Disease

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• yongjian wu, doctor

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

  STUDY CHAIR

Central Study Contacts

zhe Li, doctor

CONTACT

+86 13511031654; ada521521@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: September 12, 2021
• First Posted: September 14, 2021
• Study Start: July 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: September 20, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)