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A clinical study protocol for evaluating the effect of preoperative planning in patients with bicuspid aortic stenosis treated with computational simulation-assisted transcatheter aortic valve replacement

A clinical study protocol for evaluating the effect of preoperative planning in patients with bicuspid aortic stenosis treated with computational simulation-assisted transcatheter aortic valve replacement

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200063368
Enrollment
Unknown
Registered
2022-09-05
Start date
2022-09-05
Completion date
Unknown
Last updated
2023-04-17

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

Conditions

Aortic valvular diseases

Interventions

CT imaging decision group :N
Preoperative simulation to assist manual decision:N
Intraoperative simulation fusion group:N

Sponsors

Department of Cardiology, West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 120 Years

Inclusion criteria

Inclusion criteria: 1. Subjects aged = 18 years; 2. severe aortic stenosis; 3. Preoperative CT examination assessed the subject as a bicuspid aortic valve; 4. The subject or the subject's legal representative is aware of the nature of the study and agrees to all terms of the study, 5. And signed the informed consent form approved by the ethics committee of each clinical center; 6. Subjects are willing to complete all clinical follow-up as required by the study.

Exclusion criteria

Exclusion criteria: 1. The investigator assessed the subject as unsuitable for TAVR surgery;

Design outcomes

Primary

MeasureTime frame
implantation depth;

Countries

China

Contacts

Public ContactMao Chen
hmaochen@vip.sina.com+86 18980602046

Outcome results

None listed

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