Actively Recruiting

Age: 50Years - 70Years
All Genders
NCT06517537

Modified Aortic Root Enlargement Procedure

Led by China National Center for Cardiovascular Diseases · Updated on 2024-08-27

64

Participants Needed

1

Research Sites

128 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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 efficacy of modified ARE; Compare the incidence and clinical outcomes of moderate to severe PPM after modified ARE and TAVR surgery; Evaluate the feasibility of postoperative mid valve TAVR and explore the most ideal initial surgical plan for this type of patient from a full lifecycle perspective.

CONDITIONS

Official Title

Modified Aortic Root Enlargement Procedure

Who Can Participate

Age: 50Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Symptomatic severe aortic stenosis patients aged 50 to 70 years planning biological valve replacement
  • Echocardiography diagnostic criteria: mean transvalvular pressure gradient 240 mmHg or flow velocity 24 4.0 m/s, aortic valve area 24 0.8 cm2 or indexed effective orifice area <0.5 cm2/m2
  • Small aortic annulus defined as mean aortic annulus diameter 24 23 mm measured by CT
Not Eligible

You will not qualify if you...

  • High surgical risk with STS score >8%
  • Severe lesions in multiple coronary arteries requiring PCI or CABG
  • Need for simultaneous surgery for severe mitral and tricuspid valve disease
  • Presence of other complex cardiovascular diseases requiring surgery
  • Severe pulmonary arterial hypertension or left ventricular dysfunction with LVEF <40%
  • Severe respiratory, liver, kidney, or other important organ dysfunction
  • Active infective endocarditis
  • Previous history of cardiac surgery

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Fuwai Hospital

Beijing, Beijing Municipality, China

Actively Recruiting

Loading map...

Research Team

X

xiao peng hu, doctor

CONTACT

J

jianing cui, bachelor

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here