Sapien 3 Transcatheter Aortic Valve Replacement in Young Aortic Valve Stenosis Patients Fr
Safety, effectiveness and durability of Sapien 3 transcatheter aortic valve replacement in young aortic valve stenosis patients from China：A multi-center, retrospective and prospective, single arm, observational study
| Condition(s) | AORTIC VALVE DISEASES, Bicuspid Aortic Valve (BAV) |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | Safety, effectiveness and durability of Sapien 3 transcatheter aortic valve replacement in young aortic valve stenosis patients from China：A multi-center, retrospective and prospective, single arm, observational study |
| Who can participate | Inclusion Criteria: Subjects must meet ALL of the following inclusion criteria to be eligible for participation: * 50 years of age or older but ≤70 years old at time of consent. * Severe AS, defined as follows: a) For symptomatic patients: i) Aortic valve area ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), OR mean gradient ≥40 mm Hg, OR Maximal aortic valve velocity ≥4.0 m/sec by transthoracic echocardiography at rest b) For asymptomatic patients: i) Very severe AS with an aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), AND maximal aortic velocity ≥5.0 m/sec, or mean gradient ≥60 mm Hg by transthoracic echocardiography at rest, OR ii) Aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), AND a mean gradient ≥40 mm Hg or maximal aortic |
| Ages | 50 Years to 70 Years |
| Sex | All |
| Lead sponsor | Xijing Hospital |
| Locations | Xi'an, Shaanxi, China; Chengdu, Sichuan, China; Beijing, China; Shanghai, China |
| Start date | 2025-04-24 |
| NCT ID | NCT06830499 |
| Official listing | https://clinicaltrials.gov/study/NCT06830499 |