Modified Aortic Root Enlargement Procedure

Last updated: August 25, 2024
Sponsor: China National Center for Cardiovascular Diseases
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT06517537
2024-2357
  • Ages 50-70
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. Symptomatic severe AS patients aged 50-70 years who are planning to undergobiological 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 asmean aortic annulus diameter ≤ 23 mm measured by CT)

Exclusion

Exclusion Criteria:

  1. High surgical risk, STS score>8% 2) Severe lesions in multiple coronaryarteries requiring PCI or CABG 3) Simultaneous surgical intervention isrequired for severe mitral and tricuspid valve disease 4) Combining othercomplex 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 otherimportant organ dysfunction combined 8) Concurrent infective endocarditis inactive phase 9) Previous history of cardiac surgery

Study Design

Total Participants: 64
Study Start date:
July 15, 2024
Estimated Completion Date:
December 31, 2026

Study 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

Connect with a study center

  • Fuwai Hospital

    Beijing, Beijing
    China

    Active - Recruiting

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