Modified procedure for enlarging the aortic root in patients with small aortic annulus
Official title: The Observational Study of Modified Aortic Root Enlargement Procedure in Aortic Stenosis Patients With Small Aortic Annulus
Run by China National Center for Cardiovascular Diseases · NCT06517537 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 50 Years to 70 Years |
| Sex | All |
| Enrollment | 64 (estimated) |
| Sponsor | China National Center for Cardiovascular Diseases Government |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | July 15, 2024 |
| Main results expected | December 31, 2025 |
| Study ends | December 31, 2026 |
| Registry record updated | August 27, 2024 |
| Trial ID | NCT06517537 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are symptomatic severe aortic stenosis patients aged 50-70 with a small aortic annulus planning to undergo biological valve replacement.
✕Probably not a fit
Patients with high surgical risk or severe comorbidities that require simultaneous surgical interventions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
Fuwai Hospital
Beijing, Beijing Municipality, China Recruiting
Study contacts
- Study coordinator: xiao peng hu, doctor
- Email: 13621188439@139.com
- Phone: 13621188439
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Y‑incision versus standard aortic root enlargement for people with a small aortic annulus
This compares the Y‑incision versus standard surgical enlargement to see if surgeons can implant larger valves and reduce patient‑prosthesis mismatch in adults needing aortic valve replacement who have a small aortic annulus.
-
Conscious Sedation vs General Anesthesia for Pulsed Field Ablation in Paroxysmal Atrial Fibrillation
This trial tests whether local anesthesia with conscious sedation can match general anesthesia for pulsed field ablation in adults with paroxysmal atrial fibrillation.
-
Biomarkers to predict CSA-AKI risk before heart surgery
This study tests new biomarkers to see if they can predict CSA-AKI risk in adults undergoing cardiovascular surgery.
-
Safety and Efficacy of an Extracorporeal Ventricular Assist System for Cardiogenic Shock
This study tests whether an extracorporeal ventricular assist device can safely provide short-term heart support and help patients with cardiogenic shock or trouble weaning from bypass.
-
QFR-Guided Heart Revascularization Quality Registry in CAD
This registry tests whether using quantitative flow ratio (QFR) to guide coronary revascularization decisions across many centers can standardize quality in patients with coronary artery disease.
-
Perioperative GFR Monitoring to Predict CSA-AKI and CA-AKI
This study tests whether perioperative transcutaneous fluorescence GFR measurements can predict CSA-AKI or CA-AKI in adults undergoing cardiovascular procedures or iodine contrast exposure.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.