Down Sizing Strategy (HANGZHOU Solution) vs Standard Sizing Strategy TAVR in Bicuspid Aortic Stenosis (Type 0)

Launched by SECOND AFFILIATED HOSPITAL, SCHOOL OF MEDICINE, ZHEJIANG UNIVERSITY · Aug 22, 2022

Keywords

ClinConnect Summary

This clinical trial, titled the Down Sizing Strategy (HANGZHOU Solution) vs Standard Sizing Strategy TAVR in Bicuspid Aortic Stenosis (Type 0), is focused on comparing two different techniques for replacing a damaged heart valve in patients with a specific type of heart condition known as bicuspid aortic stenosis. The study aims to find out whether a "down sizing" strategy, which uses a smaller valve, is more effective than the standard method when using self-expanding valves. This research is currently looking for participants aged 65 and older, or those aged 60 to 64 who are at high risk for surgery due to their health conditions.

If you or someone you know is interested in participating, you need to have severe bicuspid aortic stenosis and meet certain health criteria, such as having specific measurements related to your heart's function. Participants will receive the TAVR procedure, and doctors will monitor their progress to see how well each valve sizing strategy works. It's important to understand that certain health issues might prevent someone from joining the trial, like recent heart attacks or severe bleeding risks. This study could help improve treatment options for patients with similar heart conditions in the future.

Gender

ALL

Eligibility criteria

• 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.