HANGZHOU Solution in Bicuspid AS Undergoing TAVR

Launched by SECOND AFFILIATED HOSPITAL, SCHOOL OF MEDICINE, ZHEJIANG UNIVERSITY · Jan 20, 2021

Keywords

ClinConnect Summary

The HANGZHOU clinical trial is studying two different methods for placing a heart valve in patients with a specific heart condition called bicuspid aortic stenosis. This condition occurs when the aortic valve has only two flaps instead of three, making it narrow and difficult for blood to flow out of the heart. The trial compares a new technique, called the "Hangzhou solution," with a standard method to see which is more effective for patients undergoing a procedure called transcatheter aortic valve replacement (TAVR).

To participate in this trial, you must be at least 65 years old, or between 60 and 65 years old with a high risk of surgery. You should have severe bicuspid aortic stenosis, which can be measured by specific tests. Participants in the trial will receive detailed information about the study and must agree to its terms. If you join, you can expect to work closely with healthcare providers who will monitor your progress and help ensure your safety throughout the process.

Gender

ALL

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.