Modified Aortic Root Enlargement Procedure

Recruiting

• Conditions: Small Aortic Annulus; Aortic Root Enlargement Procedure

• Registration Number: NCT06517537
• Lead Sponsor: China National Center for Cardiovascular Diseases

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-7-19
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

Inclusion Criteria:<br><br> - <br><br> 1) Symptomatic severe AS patients aged 50-70 years who are planning to undergo<br> biological valve replacement (diagnostic criteria for echocardiography are:<br> mean transvalvular pressure gradient = 40mmHg or flow velocity = 4.0 m/s,<br> aortic valve area (AVA) = 0.8 cm2 or iEOA<0.5 cm2/m2) 2) Merge SAA (defined as<br> mean aortic annulus diameter = 23 mm measured by CT)<br><br>Exclusion Criteria:<br><br> - <br><br> 1) High surgical risk, STS score>8% 2) Severe lesions in multiple coronary<br> arteries requiring PCI or CABG 3) Simultaneous surgical intervention is<br> required for severe mitral and tricuspid valve disease 4) Combining other<br> complex cardiovascular diseases requires simultaneous surgical treatment 6)<br> Combined severe pulmonary arterial hypertension or left ventricular dysfunction<br> (LVEF<40%) 7) Severe respiratory, liver and kidney dysfunction, or other<br> important organ dysfunction combined 8) Concurrent infective endocarditis in<br> active phase 9) Previous history of cardiac surgery

Exclusion Criteria

Not provided

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of moderate PPM and severe PPM after surgery