Aortic Stenosis With Bicuspid ValveTAILOR-TAVRNCT05511792
Down Sizing Strategy (HANGZHOU Solution) vs Standard Sizing Strategy TAVR in Bicuspid Aortic Stenosis (Type 0)
A study testing TAVR for BAV Using Down Sizing with the Evolut Pro platform and TAVR for BAV Using Traditional Sizing strategy with the Evolut Pro platform in people with Aortic Stenosis With Bicuspid Valve, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 15 sites in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Aortic Stenosis With Bicuspid Valve
- What is being tested?
- TAVR for BAV Using Down Sizing with the Evolut Pro platform and TAVR for BAV Using Traditional Sizing strategy with the Evolut Pro platform
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 15 sitesChina
- Study dates
- 20 Jul 2022to 30 May 2031
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- Aortic valve type cannot be determined (Sievers classification).
- 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°).
- Ascending aorta diameter > 50 mm.
- Aortic or iliofemoral vessel characteristics that would preclude safe placement of the introducer sheath.
- Patient is considered high risk for TAVR by CT corelab, including coronary obstruction, annular rupture and other severe TAVR-Related complications.
- Previous pacemaker implantation.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
China15 sites
The Second XIANGYA Hospital Of Central South University
Changsha, Hunan
Fujian Provincial Hospital, Affiliated to Fuzhou University
Fuzhou, Fujian
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, 510515
SUN YAT-SEN MEMORIAL HOSPITAL SUN YAT-SEN University
Guangzhou, Guangdong
The Second Affiliated Hospital Zhejiang University School of Medicine.
Hangzhou, Zhejiang, 310006
Lanzhou University First Hospital
Lanzhou, Gansu, 730000
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
Ning Bo First Hospital
Ningbo, Zhejiang, 315010
Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266000
Qingdao Municipal Hospital
Qingdao, Shandong, 266000
Xinjiang Uygur Autonomous Region People's Hospital
Ürümqi, Xinjiang
First Affiliated Hospital of Xi 'an Jiaotong University
Xi'an, Shaanxi
Xiamen Cardiovascular Hospital Xiamen University
Xiamen, Fujian
Yulin First People's Hospital
Yulin, Guangxi, 537000
Zhengzhou Seventh People's Hospital
Zhengzhou, Henan, 450016
About this study
Official title: 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
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
Read the 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.
- Conditions
- Aortic Stenosis With Bicuspid Valve
- Being tested
- TAVR for BAV Using Down Sizing with the Evolut Pro platform, TAVR for BAV Using Traditional Sizing strategy with the Evolut Pro platform
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAVR for BAV Using Down Sizing with the Evolut Pro platformProcedure or surgery
Also called Down Sizing Strategy
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 platformProcedure or surgery
Also called Standard Sizing Strategy
Traditional sizing strategy in Type 0 bicuspid aortic stenosis patients undergoing transcatheter aortic valve replacement with self-expanding valves
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: TAVR for BAV Using Traditional Sizing strategy with the Evolut Pro platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 month after index procedure
Secondary outcomes (4)
New onset complete left bundle branch block
New onset complete left bundle branch block with QRS ≥120ms at 1 month
Measured: 1 month after index procedure
Permanent pacemaker implantation
Permanent pacemaker implantation within one month
Measured: 1 month after index procedure
Device success Rate
Device success per VARC-3 definition
Measured: 1 month after index procedure
More than (≥) moderate regurgitation
More than (≥) moderate regurgitation on echocardiography at 1month
Measured: 1 month after index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2022
- Study start20 Jul 2022
- Primary completion22 Jun 2026
- Study completion30 May 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aortic Stenosis With Bicuspid ValveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 206 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jian' an Wang, PhD, MD, Study chair, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05511792
- Sponsor's protocol ID
- SAHZU 2022-0327
- Acronym
- TAILOR-TAVR
- Status last verified
- Oct 2026
- First submitted
- 28 Jun 2022
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: undecided
Publications
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.
PubMed 38701961