The Observational Study of Modified Aortic Root Enlargement Procedure in Aortic Stenosis Patients With Small Aortic Annulus

Status: Recruiting
Location: See location...
Study Type: Observational
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 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 70
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
China
Fuwai Hospital
RECRUITING
Beijing
Contact Information
Primary
xiao peng hu, doctor
13621188439@139.com
13621188439
Backup
jianing cui, bachelor
18738175105@163.com
18738175105
Time Frame
Start Date: 2024-07-15
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 64
Treatments
ARE
The ARE group underwent modified ARE+AVR surgery
TAVR
TAVR group undergoes routine TAVR surgery
Related Therapeutic Areas
Sponsors
Leads: China National Center for Cardiovascular Diseases

This content was sourced from clinicaltrials.gov