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
508 participants
INTERVENTIONAL
2021-04-12
2028-04-01
Brief Summary
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Detailed Description
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Clinical experience in China suggests bicuspid aortic valves and heavy calcium burden are more common among TAVR candidates. Morphological characteristics at supra-annular structure (from annulus to the level of sinotubular junction) are quite complex in bicuspid AS, especially concomitant with heavily calcified leaflets. Because only two leaflet hinge points provide the definition of the annulus plane, current CT-based annulus measurements might not be accurate under these circumstances. From previous single center clinical practice, "waist sign" above the annulus during balloon aortic valvuloplasty in TAVR was often observed in patients with bicuspid AS, indicating that the supra-annular structure may serve a key role in anchoring the THV.
Therefore, we developed a balloon based supra-annular sizing strategy (Hangzhou Solution) for SEV implantation in bicuspid AS. From our single center experience, the device success rate and pacemaker implantation rate were relatively low.
The aim of this study is to compare supra-annular sizing and THV implantation technique (Hangzhou solution) versus annular sizing and THV implantation technique (control group) in bicuspid aortic stenosis (AS) patients undergoing transcatheter aortic valve replacement (TAVR) with self-expanding valves (SEVs).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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TAVR with Supra-annular sizing strategy
Experimental: Supra-annular sizing strategy (Hangzhou Solution).
Pre-dilation with balloon size (20/23/26mm Z-MED) just below the annular size.
Waist sign with less than mild contrast regurgitation: Venus A plus Valve down size and Target implant depth 0-2mm.
No waist sign and/or contrast regurgitation or unable to finish supra-annular sizing: annular sizing Venus A plus Valve with implant depth 4-6mm.
TAVR with Venus A plus using supra-annular sizing and THV implantation technique (Hangzhou solution)
Transcatheter aortic valve replacement (TAVR) with Venus A plus using supra-annular sizing and THV implantation technique (Hangzhou solution)
TAVR with Annulus based sizing strategy
Control: Traditional sizing strategy (Annulus based sizing strategy).
Pre-dilation with balloon size (20/23/26mm Z-MED) just below the annular size.
Annular sizing Venus A plus Valve with implant depth 4-6mm.
TAVR with Venus A plus using annular sizing and THV implantation technique
Transcatheter aortic valve replacement (TAVR) with Venus A plus using annular sizing and THV implantation technique (Traditional sizing strategy)
Interventions
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TAVR with Venus A plus using supra-annular sizing and THV implantation technique (Hangzhou solution)
Transcatheter aortic valve replacement (TAVR) with Venus A plus using supra-annular sizing and THV implantation technique (Hangzhou solution)
TAVR with Venus A plus using annular sizing and THV implantation technique
Transcatheter aortic valve replacement (TAVR) with Venus A plus using annular sizing and THV implantation technique (Traditional sizing strategy)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age \<65 years and age ≥ 60 years with high surgical risk after combing STS Risk Estimate, Katz activities of Daily Living, major Organ System Dysfunction and Procedure-Specific Impediment;
* Severe, bicuspid aortic stenosis:
* Mean gradient ≥40 mmHg
* Maximal aortic valve velocity ≥4.0 m/sec
* Aortic valve area ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2)
* NYHA classification ≥ II;
* Type 0, type 1 (Sievers classification) by MDCT
* Perimeter-derived annulus diameter ranges from 20.0 mm to 29.0 mm;
* 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.
Exclusion Criteria
* 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.
* 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.
60 Years
ALL
No
Sponsors
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Venus MedTech (HangZhou) Inc.
INDUSTRY
The First Affiliated Hospital of Bengbu Medical University
OTHER
Chinese PLA General Hospital
OTHER
Fujian Medical University Union Hospital
OTHER
Xiamen University Affiliated Cardiovascular Hospital
UNKNOWN
The Second People's Hospital of GuangDong Province
OTHER
Chinese Academy of Medical Sciences, Fuwai Hospital
OTHER
The First Affiliated Hospital of Zhengzhou University
OTHER
Henan Provincial Chest Hospital
OTHER
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
OTHER
Central South University
OTHER
Northern Jiangsu People's Hospital
OTHER
The First Affiliated Hospital of Nanchang University
OTHER
Second Affiliated Hospital of Nanchang University
OTHER
The Affiliated Hospital of Qingdao University
OTHER
Shanxi Cardiovascular Hospital
OTHER
Tianjin Chest Hospital
OTHER
Ning Bo First Hospital
UNKNOWN
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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The First affiliated hospital of bengbu medical college
Bengbu, Anhui, China
The General Hospital of the People's Liberation Army
Beijing, Beijing Municipality, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Xiamen University Affiliated Cardiovascular Hospital
Xiamen, Fujian, China
Guangdong People's Hospital
Guangzhou, Guangdong, China
Zhengzhou Cardiovascular Hospital
Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Hennan Provincial Chest Hospital
Zhengzhou, Hennan, China
Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
The Second XIANGYA Hospital Of Central South University
Changsha, Hunan, China
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Shanxi Cardiovascular Hospital
Taiyuan, Shanxi, China
tianjin Chest Hospital
Tianjing, Tianjing, 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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Yundai Chen
Role: primary
Other Identifiers
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2021-0007
Identifier Type: -
Identifier Source: org_study_id
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