NCT06517537

Modified Aortic Root Enlargement Procedure

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 64 (estimated)
• Sponsor: China National Center for Cardiovascular Diseases · Other Government
• Sex: All
• Age: 50 Years – 70 Years
• Healthy volunteers: Not accepted

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.

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 valve mismatch (PPM) and an elevated late mortality rate. The optimal approach for treating SAA remains controversial. Transcatheter aortic valve replacement (TAVR) has yielded superior valvular hemodynamic outcomes in patients with SAA; however, the incidence of PPM subsequent to surgery remains considerable. Aortic root enlargement (ARE) represents an effective solution for SAA, but the conventional method of aortic ring enlargement for ARE has restricted efficacy. In 2021, Yang Bo proposed an enhanced ARE approach, where the mitral curtain of the aortic valve was incised in an inverted Y-shape along the left non-coronary junction, enabling the enlargement of the number 3-5 of the aortic ring

Conditions

• Small Aortic Annulus
• Aortic Root Enlargement Procedure

Timeline

• Start date: 2024-07-15
• Primary completion: 2025-12-31
• Completion: 2026-12-31
• First posted: 2024-07-24
• Last updated: 2024-08-27

Locations

1 site across 1 country: China