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

NCT05511792 | Recruiting DMC

• 1 other identifier: SAHZU 2022-0327
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 15

Brief 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

Conditions

Aortic Stenosis With Bicuspid Valve

Outcome Measures

Primary Outcomes (1)

• Composite endpoint of Clinical Event Rate of Device Success (VARC-3), Free of pacemaker implantation, and Free of new onset complete left bundle branch block at 1 month

  Composite endpoint of Device Success (VARC-3), Free of pacemaker implantation, and Free of new onset complete left bundle branch block at 1 month

  1 month after index procedure

Secondary Outcomes (4)

• New onset complete left bundle branch block

  1 month after index procedure

• Permanent pacemaker implantation

  1 month after index procedure

• Device success Rate

  1 month after index procedure

• More than (≥) moderate regurgitation

  1 month after index procedure

Study Arms (2)

TAVR with down sizing strategy

EXPERIMENTAL

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.

Procedure: TAVR for BAV Using Down Sizing with the Evolut Pro platform

TAVR with standard sizing strategy

ACTIVE COMPARATOR

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.

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

Interventions

TAVR for BAV Using Down Sizing with the Evolut Pro platform PROCEDURE

Down sizing strategy in Type 0 bicuspid aortic stenosis patients undergoing transcatheter aortic valve replacement with self-expanding valves

Also known as: Down Sizing Strategy

TAVR with down sizing strategy

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

Traditional sizing strategy in Type 0 bicuspid aortic stenosis patients undergoing transcatheter aortic valve replacement with self-expanding valves

Also known as: Standard Sizing Strategy

TAVR with standard sizing strategy

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 65 years;
• 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;
• 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;
• NYHA classification ≥ II;
• Type 0 (Sievers classification) by MDCT;
• Perimeter-derived annulus diameter ranges from 20.0 mm to 26.0 mm;
• Candidate for Transfemoral TAVR;
• 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.

You may not qualify if:

• 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).
• Active sepsis, including active bacterial endocarditis with or without treatment;
• Evidence of an acute myocardial infarction ≤ 1 month (30 days) before the intended treatment \[(defined as: Q wave MI, or non-Q wave MI with total CK elevation of CK-MB ≥ twice normal in the presence of MB elevation and/or troponin level elevation (WHO definition)\].
• Stroke or transient ischemic attack (TIA) within 3 months (90 days) of the procedure.
• Estimated life expectancy \< 12 months (365 days) due to carcinomas, chronic liver disease, chronic renal disease or chronic end stage pulmonary disease.
• Any Emergent surgery required before TAVR procedure.
• 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
• Gastrointestinal (GI) bleeding that would preclude anticoagulation.
• Subject refuses a blood transfusion.
• 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).
• 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.
• Currently participating in an investigational drug or another device study (excluding registries).
• Hypertrophic cardiomyopathy (HCM with myocardium more than 1.5cm without an identifiable cause) with obstruction (HOCM).
• Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
• Severe mitral stenosis amenable to surgical replacement or repair.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (15)

Fujian Provincial Hospital, Affiliated to Fuzhou University

Fuzhou, Fujian, China

RECRUITING

Xiamen Cardiovascular Hospital Xiamen University

Xiamen, Fujian, China

RECRUITING

Lanzhou University First Hospital

Lanzhou, Gansu, 730000, China

RECRUITING

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

SUN YAT-SEN MEMORIAL HOSPITAL SUN YAT-SEN University

Guangzhou, Guangdong, China

RECRUITING

Yulin First People's Hospital

Yulin, Guangxi, 537000, China

RECRUITING

Zhengzhou Seventh People's Hospital

Zhengzhou, Henan, 450016, China

RECRUITING

The Second XIANGYA Hospital Of Central South University

Changsha, Hunan, China

RECRUITING

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

RECRUITING

First Affiliated Hospital of Xi 'an Jiaotong University

Xi'an, Shaanxi, China

RECRUITING

Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266000, China

RECRUITING

Qingdao Municipal Hospital

Qingdao, Shandong, 266000, China

RECRUITING

Xinjiang Uygur Autonomous Region People's Hospital

Ürümqi, Xinjiang, China

RECRUITING

The Second Affiliated Hospital Zhejiang University School of Medicine.

Hangzhou, Zhejiang, 310006, China

RECRUITING

Ning Bo First Hospital

Ningbo, Zhejiang, 315010, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 38701961 DERIVED

Study Officials

• Jian' an Wang, PhD, MD

  2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

  STUDY CHAIR

Central Study Contacts

Jian' an Wang, PhD, MD

CONTACT

+86057187783777; wja@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and Outcomes Assessors all remain unaware of the intervention assignments throughout the trial.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2022
• First Posted: August 23, 2022
• Study Start: June 27, 2022
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): June 30, 2030
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (15)