HANGZHOU Solution in Bicuspid AS Undergoing TAVR

Trial details

Who runs it

Second Affiliated Hospital, Zhejiang University, School of Medicine

Trial code

NCT04722796

Record updated

2 June 2021

Original description

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 trialRead full original descriptionShow less

HANGZHOU Solution for Patients With Bicuspid Aortic Stenosis Undergoing Transcatheter Aortic Valve Replacement by Using Supra-annular Structure Based Balloon Sizing Strategy

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

Inclusion: 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.

Exclusion: Any Emergent surgery required before TAVR procedure; Currently participating in an investigational drug or another device study (excluding registries); Severe mitral stenosis amenable to surgical replacement or repair; Previous pacemaker implantation; 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; 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; 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; 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°); Leukopenia (WBC < 3000 cell/mL), acute anemia (Hgb < 9 g/dL), Thrombocytopenia (Plt< 50,000 cell/mL); Any contra-indication for Self-expanding bioprosthetic aortic valve deployment; Active sepsis, including active bacterial endocarditis with or without treatment; Subject refuses a blood transfusion; Hypertrophic cardiomyopathy (HCM with myocardium more than 1.5cm without an identifiable cause) with obstruction (HOCM); Echocardiographic evidence of intracardiac mass, thrombus or vegetation; Aortic valve type cannot be determined (Sievers classification); 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.

ClinicalTrials.gov NCT04722796