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Study for the efficacy and safety of transcatheter aortic valve replacement for aortic valve disease with J-valve bioprosthesis

Study for the efficacy and safety of transcatheter aortic valve replacement for aortic valve disease with J-valve bioprosthesis

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900023041
Enrollment
Unknown
Registered
2019-05-08
Start date
2019-06-01
Completion date
Unknown
Last updated
2019-05-13

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

Conditions

Aortic valve regurgitation

Interventions

1:TAVR

Sponsors

West China School of Medicine/West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) Aged 60 years or older, NYHA functional class II- IV; (2) Aortic regurgitation (above moderate level) with definite clinical symptoms; (3) Aortic stenosis (effective orifice area 40mmHg); (4) Aortic annulus >29mm or trans-apex prohibitive AR patients; (5) All the implanted valves in TAVI group are J-valve bioprosthesis.

Exclusion criteria

Exclusion criteria: (1) Aortic disease complicated by infective endocarditis or other active infections; (2) Aortic disease complicated by severe mitral valve disease; (3) Patients need to undergo operation on great artery; (4) Diameter of annulus >29mm or <18mm in TAVI group; (5) Hypocoagulation, severe hemorrhagic tendency, prohibited anticoagulation therapy or anticoagulation taboo; (6) Onset of TIA or severe stroke or severe dementia within 6 months; (7) Myocardial infarction within a month; (8) Left ventricular thrombus, excrescence or left ventricular outflow tract obstruction; (9) Instable hemodynamics, requirement of large amounts of myocardial contractile force drug or mechanical cardiac assist; (10) Hypertrophic cardiomyopathy; (11) Severe pulmonary arterial hypertension or right ventricular insufficiency; (12) Serious disease with life expectancy less than 1 year.

Design outcomes

Primary

MeasureTime frame
STS score;EuroScore;NYHA class;Length of stay in ICU;Length of stay in hospital;Death;

Countries

China

Contacts

Public ContactGuo Yingqiang

West China Hospital, Sichuan University

drguoyq@hotmail.com+86 18980601876

Outcome results

None listed

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