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To align the coaptation margin of the self-expanding valve with that of the native valve in transcatheter aortic valve replacement (TAVR) using markers on the delivery system, and to observe the effect of coronary artery occlusion on the suture plane of the valve

To align the coaptation margin of the self-expanding valve with that of the native valve in transcatheter aortic valve replacement (TAVR) using markers on the delivery system, and to observe the effect of coronary artery occlusion on the suture plane of the valve

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200063929
Enrollment
Unknown
Registered
2022-09-21
Start date
2022-09-20
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 stenosis

Interventions

Intervention Group:commissural alignment via hat marker in TAVR

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Severe aortic stenosis, defined as aortic orifice area 40 mmHg on resting echocardiography or maximum aortic orifice flow rate > 4.0 m/s; 2. The patient had symptoms, such AS shortness of breath, chest pain, syncope, NYHA cardiac function grade ? or above, and the symptoms were clearly caused by AS; 3. Anatomically suitable for TAVR: including the degree of valve calcification, aortic ring diameter, aortic sinus diameter and height, coronary artery opening height, entry diameter and so on; 4. Life expectancy after treatment of AS is more than 12 months; 5. Age requirement of patients: there is no age requirement for patients at high risk of surgery; Middle or high risk surgery patients, aged >=70 years; Patients under 70 years of age are considered suitable for TAVR by the cardiac team based on surgical risk and patient willingness.

Exclusion criteria

Exclusion criteria: 1. Left ventricular thrombus, left ventricular outflow tract obstruction, entrance diameter; 2. Any conditions considered contraindications for artificial biological valve implantation; 3. Bifid aortic valve has no cristae type (Sievers type was 0).

Design outcomes

Primary

MeasureTime frame
all-cause mortality;

Countries

China

Contacts

Public ContactChen Mao

West China Hospital, Sichuan University

hmaochen@vip.sina.com+86 18980602046

Outcome results

None listed

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