Modified procedure for enlarging the aortic root in patients with small aortic annulus
The Observational Study of Modified Aortic Root Enlargement Procedure in Aortic Stenosis Patients With Small Aortic Annulus
This study is testing a new way to enlarge the aortic root in people aged 50-70 with severe aortic stenosis and a small aortic annulus to see if it works better than the standard valve replacement method.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 64 (estimated) |
| Ages | 50 Years to 70 Years |
| Sex | All |
| Sponsor | China National Center for Cardiovascular Diseases Government |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06517537 on ClinicalTrials.gov |
What this trial studies
This observational clinical trial investigates the safety and efficacy of a modified aortic root enlargement (ARE) procedure in patients aged 50-70 with severe aortic stenosis and small aortic annulus. Participants will choose between the modified ARE and transcatheter aortic valve replacement (TAVR) to evaluate clinical outcomes, particularly the incidence of prosthetic valve mismatch (PPM) after surgery. The study aims to explore the feasibility of postoperative mid valve TAVR and identify the most effective initial surgical approach for these patients.
Who should consider this trial
Good fit: Ideal candidates are symptomatic severe aortic stenosis patients aged 50-70 with a small aortic annulus planning to undergo biological valve replacement.
Not a fit: Patients with high surgical risk or severe comorbidities that require simultaneous surgical interventions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer and more effective surgical option for patients with small aortic annulus, potentially reducing postoperative complications.
How similar studies have performed: While TAVR has shown success in similar patient populations, the modified ARE approach is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Beijing, Beijing Municipality
- Fuwai Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: xiao peng hu, doctor
- Email: 13621188439@139.com
- Phone: 13621188439
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.