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RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This 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

Who May Be Eligible (Plain English)

Who May Qualify: 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 willing to sign a consent form as approved by the Institutional Review Board (IRB)/Ethics Committee (EC) of the respective clinical site. Who Should NOT Join This Trial: 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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. 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.

Treatments Being Tested

PROCEDURE

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

PROCEDURE

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

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
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