Modified Aortic Root Enlargement Procedure

NCT06517537 · tracked via the Priya Life Science China tracker

Sponsor

China National Center for Cardiovascular Diseases

Phase

Observational

Started

2024-07-15

Last updated

2024-08-27

Condition(s) studied

Small Aortic AnnulusAortic Root Enlargement Procedure

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

Sex

ALL

Min age

50 Years

Max age

70 Years

Healthy volunteers

Inclusion Criteria: * 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) Exclusion Criteria: * 1\) High surgical risk, STS score\>8% 2) Severe lesions in multiple coronary arteries requiring PCI or CABG 3) Simultaneous surgical intervention is required for severe mitral and tricuspid valve disease 4) Combining other complex 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 other important organ dysfunction combined 8) Concurrent infective endocarditis in active phase 9) Previous history of cardiac surgery

Primary outcome measure(s)

Incidence of moderate PPM and severe PPM after surgery — Before discharge, 3 months after surgery, and 1 year after surgery
Prospective collection of all echocardiographic data before surgery and upon discharge, measuring mean aortic valve area (EOA), mean transvalvular pressure gradient, and the degree and type of aortic regurgitation (AR). According to the patient's BSA calculation of iEOA, 0.65-0.85cm2/m2 is diagnosed as moderate PPM, and\<0.65cm2/m2 is diagnosed as severe PPM.

Trial sites (1)

Facility	City	Region	Status
Fuwai Hospital	Beijing	Beijing Municipality	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06517537 on ClinicalTrials.gov ↗ ← All trials in China