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Down Sizing Strategy (HANGZHOU Solution) vs Standard Sizing Strategy TAVR in Bicuspid Aortic Stenosis (Type 0) | Clinical Trials | Clareo Health

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Down Sizing Strategy (HANGZHOU Solution) vs Standard Sizing Strategy TAVR in Bicuspid Aortic Stenosis (Type 0)

Transcatheter Aortic Valve Replacement For Patients With Bicuspid Aortic Stenosis (Type 0) Using Down Sizing Strategy Compared With Standard Sizing Strategy (HANGZHOU Solution): A Prospective, Multicenter, Randomized Controlled Trial

NCT05511792•Second Affiliated Hospital, School of Medicine, Zhejiang University

View on ClinicalTrials.gov

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

Detailed Description

Transcatheter aortic valve replacement (TAVR) has emerged as a favorable alternative for severe symptomatic aortic stenosis (AS) patients of all surgical risk profiles. Patients with bicuspid aortic valve (BAV) underwent TAVR had similar 30-day mortality as well as stroke and new pacemaker implantation rates compared to tricuspid aortic valve (TAV) subjects, but carried higher risk of moderate/severe perivalvular leakage (PVL), conversion to surgery and device failure. Clinical experience in China suggests BAV and heavy calcium burden are more common among TAVR candidates than US/EU cohorts. 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.

Eligibility

Age

60 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age ≥ 65 years;
•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

•1. Any contra-indication for Self-expanding bioprosthetic aortic valve deployment Leukopenia (WBC \< 3000 cell/mL), acute anemia (Hgb \< 9 g/dL), Thrombocytopenia (Plt\< 50,000 cell/mL).
•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 more criteria

Locations (15)

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

Key Dates

Start Date

June 27, 2022

Primary Completion Date

July 30, 2026

Completion Date

June 30, 2030

Last Updated

October 3, 2025

Enrollment

206

ESTIMATED participants

Conditions

Aortic Stenosis With Bicuspid Valve

Interventions

TAVR for BAV Using Down Sizing with the Evolut Pro platform

PROCEDURE

TAVR for BAV Using Traditional Sizing strategy with the Evolut Pro platform

PROCEDURE

Contacts

Jian' an Wang, PhD, MD

CONTACT

+86057187783777 wja@zju.edu.cn