Status:
RECRUITING
Modified Aortic Root Enlargement Procedure
Lead Sponsor:
China National Center for Cardiovascular Diseases
Conditions:
Small Aortic Annulus
Aortic Root Enlargement Procedure
Eligibility:
All Genders
50-70 years
Brief Summary
This study is a prospective observational clinical trial, in which severe AS patients aged 50-70 years with SAA choose modified ARE or TAVR according to their wishes to investigate the safety and effi...
Detailed Description
Small aortic annulus (SAA), which is prevalently observed in patients with severe aortic stenosis (AS), constitutes a significant challenge in treatment and may give rise to post-operative prosthetic ...
Eligibility Criteria
Inclusion
- 1\) Symptomatic severe AS patients aged 50-70 years who are planning to undergo biological valve replacement (diagnostic criteria for echocardiography are: mean transvalvular pressure gradient ≥ 40mmHg or flow velocity ≥ 4.0 m/s, aortic valve area (AVA) ≤ 0.8 cm2 or iEOA\<0.5 cm2/m2) 2) Merge SAA (defined as mean aortic annulus diameter ≤ 23 mm measured by CT)
Exclusion
- 1\) High surgical risk, STS score\>8% 2) Severe lesions in multiple coronary arteries requiring PCI or CABG 3) Simultaneous surgical intervention is required for severe mitral and tricuspid valve disease 4) Combining other complex cardiovascular diseases requires simultaneous surgical treatment 6) Combined severe pulmonary arterial hypertension or left ventricular dysfunction (LVEF\<40%) 7) Severe respiratory, liver and kidney dysfunction, or other important organ dysfunction combined 8) Concurrent infective endocarditis in active phase 9) Previous history of cardiac surgery
Key Trial Info
Start Date :
July 15 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT06517537
Start Date
July 15 2024
End Date
December 31 2026
Last Update
August 27 2024
Active Locations (1)
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1
Fuwai Hospital
Beijing, Beijing Municipality, China