Down Sizing Strategy (HANGZHOU Solution) vs Standard Sizing Strategy TAVR in Bicuspid Aortic Stenosis (Type 0)
NCT ID: NCT05511792
Last Updated: 2025-10-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
206 participants
INTERVENTIONAL
2022-06-27
2030-06-30
Brief Summary
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Detailed Description
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Morphological characteristics at supra-annular structure (from annulus to the level of sinotubular junction) are quite complex in BAV, especially concomitant with heavily calcified leaflets. From our previous single center clinical practice, "waist sign" above the annulus during balloon aortic valvuloplasty in TAVR was often observed in patients with bicuspid AS, suggesting that supra-annular structures are the most constrained portion of BAV anatomy where the prosthesis anchors and seals. Therefore, we developed a balloon based supra-annular sizing strategy for self-expanding valves implantation in BAV and the device failure rate as well as pacemaker implantation rates were relatively low as shown in previous cohort study. Several other studies have also achieved successful outcomes associated with device "down sizing" (using a device smaller than that recommended by annular sizing).
The aim of this study is to compare "down sizing"strategy (experimental group) versus annular sizing strategy (control group) in BAV patients undergoing TAVR with self-expanding valves.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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TAVR with down sizing strategy
Balloon sizing will be used during procedural. Pre-dilation with balloon size just below the annular size. 20mm for annular size of 20-23mm. 23mm for annular size 23-26mm.
Waist sign with less than mild contrast regurgitation: Evolut PRO Valve one size smaller than manufacturer recommendation and Target implant depth 0-3mm.
No waist sign and/or contrast regurgitation or unable to finish supra-annular sizing: Evolut PRO annular sizing (per manufacturer recommendation) with implant depth 0-3mm.
TAVR for BAV Using Down Sizing with the Evolut Pro platform
Down sizing strategy in Type 0 bicuspid aortic stenosis patients undergoing transcatheter aortic valve replacement with self-expanding valves
TAVR with standard sizing strategy
Pre-dilation with balloon size just below the annular size. 20mm for annular size of 20-23mm. 23mm for annular size 23-26mm.
The prosthesis size of Evolut PRO will be chosen based on manufacturer recommendation. The target implant depth will be 0-3mm.
TAVR for BAV Using Traditional Sizing strategy with the Evolut Pro platform
Traditional sizing strategy in Type 0 bicuspid aortic stenosis patients undergoing transcatheter aortic valve replacement with self-expanding valves
Interventions
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TAVR for BAV Using Down Sizing with the Evolut Pro platform
Down sizing strategy in Type 0 bicuspid aortic stenosis patients undergoing transcatheter aortic valve replacement with self-expanding valves
TAVR for BAV Using Traditional Sizing strategy with the Evolut Pro platform
Traditional sizing strategy in Type 0 bicuspid aortic stenosis patients undergoing transcatheter aortic valve replacement with self-expanding valves
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age \<65 years and age ≥ 60 years with high surgical risk after combing STS Risk Estimate (≥ 8%), Katz activities of Daily Living, major Organ System Dysfunction and Procedure-Specific Impediment;
3. Severe, bicuspid aortic stenosis: Mean gradient ≥40 mmHg OR Maximal aortic valve velocity ≥4.0 m/sec OR Aortic valve area ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2); if SVi \<35mL/m2, low-dose dobutamine stress echocardiography is required;
4. NYHA classification ≥ II;
5. Type 0 (Sievers classification) by MDCT;
6. Perimeter-derived annulus diameter ranges from 20.0 mm to 26.0 mm;
7. Candidate for Transfemoral TAVR;
8. The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB)/Ethics Committee (EC) of the respective clinical site.
Exclusion Criteria
2. Active sepsis, including active bacterial endocarditis with or without treatment;
3. Evidence of an acute myocardial infarction ≤ 1 month (30 days) before the intended treatment \[(defined as: Q wave MI, or non-Q wave MI with total CK elevation of CK-MB ≥ twice normal in the presence of MB elevation and/or troponin level elevation (WHO definition)\].
4. Stroke or transient ischemic attack (TIA) within 3 months (90 days) of the procedure.
5. Estimated life expectancy \< 12 months (365 days) due to carcinomas, chronic liver disease, chronic renal disease or chronic end stage pulmonary disease.
6. Any Emergent surgery required before TAVR procedure.
7. A known hypersensitivity or contraindication to any of the following that cannot be adequately medicated:aspirin or heparin (HIT/HITTS) and bivalirudin; clopidogrel; Nitinol (titanium or nickel); contrast media
8. Gastrointestinal (GI) bleeding that would preclude anticoagulation.
9. Subject refuses a blood transfusion.
10. Severe dementia (resulting in either inability to provide informed consent for the study/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits).
11. Other medical, social, or psychological conditions that in the opinion of the investigator precludes the subject from appropriate consent or adherence to the protocol required follow-up exams.
12. Currently participating in an investigational drug or another device study (excluding registries).
13. Hypertrophic cardiomyopathy (HCM with myocardium more than 1.5cm without an identifiable cause) with obstruction (HOCM).
14. Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
15. Severe mitral stenosis amenable to surgical replacement or repair.
16. Aortic valve type cannot be determined (Sievers classification).
17. Significant aortic disease, including marked tortuosity (hyperacute bend), aortic arch atheroma \[especially if thick (\> 5 mm), protruding or ulcerated\] or narrowing (especially with calcification and surface irregularities) of the abdominal or thoracic aorta, severe"unfolding" and horizontal aorta(Annular Angulation\>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.
60 Years
ALL
No
Sponsors
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Second Affiliated Hospital, School of Medicine, Zhejiang University
OTHER
Responsible Party
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Principal Investigators
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Jian' an Wang, PhD, MD
Role: STUDY_CHAIR
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Locations
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Fujian Provincial Hospital, Affiliated to Fuzhou University
Fuzhou, Fujian, China
Xiamen Cardiovascular Hospital Xiamen University
Xiamen, Fujian, China
Lanzhou University First Hospital
Lanzhou, Gansu, China
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China
SUN YAT-SEN MEMORIAL HOSPITAL SUN YAT-SEN University
Guangzhou, Guangdong, China
Yulin First People's Hospital
Yulin, Guangxi, China
Zhengzhou Seventh People's Hospital
Zhengzhou, Henan, China
The Second XIANGYA Hospital Of Central South University
Changsha, Hunan, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
First Affiliated Hospital of Xi 'an Jiaotong University
Xi'an, Shaanxi, China
Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Qingdao Municipal Hospital
Qingdao, Shandong, China
Xinjiang Uygur Autonomous Region People's Hospital
Ürümqi, Xinjiang, China
The Second Affiliated Hospital Zhejiang University School of Medicine.
Hangzhou, Zhejiang, China
Ning Bo First Hospital
Ningbo, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Yan Wang
Role: primary
Ming Bai
Role: primary
Jiancheng Xiu
Role: primary
Ruqiong Nie
Role: primary
Ping Li
Role: primary
Zuyi Yuan
Role: primary
Lei Jiang
Role: primary
Yibing Shao
Role: primary
Yining Yang
Role: primary
References
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Guo Y, Liu X, Li R, Ng S, Liu Q, Wang L, Hu P, Ren K, Jiang J, Fan J, He Y, Zhu Q, Lin X, Li H, Wang J. Comparison of downsizing strategy (HANGZHOU Solution) and standard annulus sizing strategy in type 0 bicuspid aortic stenosis patients undergoing transcatheter aortic valve replacement: Rationale and design of a randomized clinical trial. Am Heart J. 2024 Aug;274:65-74. doi: 10.1016/j.ahj.2024.04.011. Epub 2024 May 1.
Other Identifiers
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SAHZU 2022-0327
Identifier Type: -
Identifier Source: org_study_id
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