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Active Not Recruiting
NCT05511792
Down Sizing Strategy (HANGZHOU Solution) vs Standard Sizing Strategy TAVR in Bicuspid Aortic Stenosis (Type 0)
Conditions: Aortic Stenosis With Bicuspid Valve
Sex: All
Ages: 60 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 206
Sponsor: Second Affiliated Hospital, Zhejiang University, School of Medicine
Location: Fujian Provincial Hospital, Affiliated to Fuzhou University Fuzhou Fujian
Summary
To compare down sizing strategy versus annular sizing strategy technique (control group) in Type 0 bicuspid aortic stenosis (AS) patients undergoing transcatheter aortic valve replacement (TAVR) with self-expanding valves (SEVs): a randomized superiority trial
Eligibility Criteria
Inclusion criteria:
1. Age ≥ 65 years;
2. Age \70°).
18. Ascending aorta diameter \> 50 mm.
19. Aortic or iliofemoral vessel characteristics that would preclude safe placement of the introducer sheath.
20. Patient is considered high risk for TAVR by CT corelab, including coronary obstruction, annular rupture and other severe TAVR-Related complications.
21. Previous pacemaker implantation.
Source: ClinicalTrials.gov (NCT05511792). StuddyBuddy aggregates publicly available trial information.
