HANGZHOU Solution in Bicuspid AS Undergoing TAVR | NCT04722796

NCT04722796

Status Module

Name	Class
Venus MedTech (HangZhou) Inc.	INDUSTRY
The First Affiliated Hospital of Bengbu Medical University	OTHER
Chinese PLA General Hospital	OTHER

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TAVR with Supra-annular sizing strategy	Experimental	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.	Device: TAVR with Venus A plus using supra-annular sizing and THV implantation technique (Hangzhou solution)
TAVR with Annulus based sizing strategy	Other	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.	Device: TAVR with Venus A plus using annular sizing and THV implantation technique

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TAVR with Venus A plus using supra-annular sizing and THV implantation technique (Hangzhou solution)	Device	Transcatheter aortic valve replacement (TAVR) with Venus A plus using supra-annular sizing and THV implantation technique (Hangzhou solution)

Measure	Description	Time Frame
Composite of all-cause mortality rate, disabling stroke rate, new permanent pacemaker implantation rate and moderate or severe prosthetic valve regurgitation rate at 1 month	Composite of all-cause mortality, disabling stroke, new permanent pacemaker implantation and moderate or severe prosthetic valve regurgitation at 1 month (per Valve Academic Research Consortium-2 [VARC-2] criteria)	1 month

Measure	Description	Time Frame
Deaths (all-cause mortality) at 1 month	Number of deaths from any cause mortality at 1 month	1 month
Deaths (all-cause mortality) at 1 year		1 year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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 Criteria:

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.

ID	Term
D000082862	Aortic Valve Disease
D006349	Heart Valve Diseases
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014694	Ventricular Outflow Obstruction