HANGZHOU Solution in Bicuspid AS Undergoing TAVR

Recruiting now · Not applicable

Conditions studied: Aortic Stenosis, Aortic Stenosis With Bicuspid Valve

In brief

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): a randomized superiority trial

Key facts

Study ID

NCT04722796

Run by

Second Affiliated Hospital, Zhejiang University, School of Medicine

People needed

508

Starts

2021-04-12

Expected to finish

2028-04-01

Last updated by the study team

2021-06-02

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 65 years
• 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.

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.
• 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.

Where it is running

• Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology — Wuhan, Hubei, China (enrolling)
• The Second Affiliated Hospital Zhejiang University School of Medicine. — Hangzhou, Zhejiang, China (enrolling)
• Ning Bo First Hospital — Ningbo, Zhejiang, China (enrolling)
• 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
• The First affiliated hospital of bengbu medical college — Bengbu, Anhui, 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 XIANGYA Hospital Of Central South University — Changsha, Hunan, China
• The General Hospital of the People's Liberation Army — Beijing, Beijing Municipality, China
• Fujian Medical University Union Hospital — Fuzhou, Fujian, China

Full record on ClinicalTrials.gov

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