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Single-center study for anti-calcification pericardial leaflet replacement in patients with low ejection fraction (low-EF) aortic stenosis (AS)

Single-center study for anti-calcification pericardial leaflet replacement in patients with low ejection fraction (low-EF) aortic stenosis (AS)

Status
Recruiting
Phases
Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900020943
Enrollment
Unknown
Registered
2019-01-22
Start date
2019-01-31
Completion date
Unknown
Last updated
2019-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low ejection fraction aortic stenosis

Interventions

Treatment group 1:Aortic valve leaf replacement
Treatment group 2:metal valve replacement
Treatment group 3:biological valve replacement

Sponsors

The First Affiliated Hospital of Zhengzhou University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Aged at least 18 years; 2. Diagnosis of aortic stenosis, echocardiographic LVEF <50% and dobutamine test for true aortic stenosis; 3. The patient or client agrees to participate in the trial and sign an informed consent form; 4. Compliance is good, willing and able to follow-up observation as required.

Exclusion criteria

Exclusion criteria: 1. Patients who have previously had a heart valve or have had a valve; 2. Patients with other intracardiac malformations or patients requiring coronary artery bypass; 3. Patients with active endocarditis; 4. Patients who participate in other clinical studies at the same time; 5. Drug addicts or alcohol abusers; 6. The patient has severe or progressive cardiovascular or non-cardiovascular disease with a life expectancy of less than 12 months; 7. Pregnant or lactating women; 8. Patients who underwent postoperative anticoagulation according to the guidelines cannot be performed.

Design outcomes

Primary

MeasureTime frame
effective orifice area;mean transprosthetic pressure gradient;Peak flow velocity;Valve regurgitation;Pressure half time reduction;Left heart ejection fraction;Anticoagulant hemorrhagic events;arrhythmia events;endocarditis events,;left ventricular end-diastolic dimension;

Countries

China

Contacts

Public ContactLiu Chao

The First Affiliated Hospital of Zhengzhou University

liubeilun@me.com+86 13838188928

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026