Comparing two sizing strategies for TAVR in patients with bicuspid aortic stenosis

Transcatheter Aortic Valve Replacement For Patients With Bicuspid Aortic Stenosis (Type 0) Using Down Sizing Strategy Compared With Standard Sizing Strategy (HANGZHOU Solution): A Prospective, Multicenter, Randomized Controlled Trial

This study is testing whether a new way of sizing heart valves can help older patients with a specific type of aortic stenosis have fewer complications during their valve replacement procedure.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 206 (estimated)
• Ages: 60 Years and up
• Sex: All
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (Academic / other)
• Locations: 15 sites (Fuzhou, Fujian and 14 other locations)
• Trial ID: NCT05511792 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to compare a down sizing strategy against a standard annular sizing strategy for patients with Type 0 bicuspid aortic stenosis undergoing transcatheter aortic valve replacement (TAVR) using self-expanding valves. The study will randomly assign participants to either the down sizing approach or the traditional sizing method to evaluate outcomes such as device failure and pacemaker implantation rates. The trial is based on previous clinical observations suggesting that a down sizing strategy may reduce complications associated with TAVR in this patient population. The study will include patients aged 60 and older with severe bicuspid aortic stenosis and specific anatomical criteria.

Who should consider this trial

Good fit: Ideal candidates are patients aged 60 years and older with severe bicuspid aortic stenosis who are candidates for transfemoral TAVR.

Not a fit: Patients with contraindications for self-expanding bioprosthetic aortic valves will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved outcomes and reduced complications for patients undergoing TAVR for bicuspid aortic stenosis.

How similar studies have performed: Other studies have shown success with similar down sizing strategies in TAVR, suggesting potential for positive outcomes in this trial.

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.

Where this trial is running

Fuzhou, Fujian and 14 other locations

• Fujian Provincial Hospital, Affiliated to Fuzhou University — Fuzhou, Fujian, China (Recruiting)
• Xiamen Cardiovascular Hospital Xiamen University — Xiamen, Fujian, China (Recruiting)
• Lanzhou University First Hospital — Lanzhou, Gansu, China (Recruiting)
• Nanfang Hospital of Southern Medical University — Guangzhou, Guangdong, China (Recruiting)
• SUN YAT-SEN MEMORIAL HOSPITAL SUN YAT-SEN University — Guangzhou, Guangdong, China (Recruiting)
• Yulin First People's Hospital — Yulin, Guangxi, China (Recruiting)
• Zhengzhou Seventh People's Hospital — Zhengzhou, Henan, China (Recruiting)
• The Second XIANGYA Hospital Of Central South University — Changsha, Hunan, China (Recruiting)
• The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (Recruiting)
• First Affiliated Hospital of Xi 'an Jiaotong University — Xi'an, Shaanxi, China (Recruiting)
• Affiliated Hospital of Qingdao University — Qingdao, Shandong, China (Recruiting)
• Qingdao Municipal Hospital — Qingdao, Shandong, China (Recruiting)
• Xinjiang Uygur Autonomous Region People's Hospital — Ürümqi, Xinjiang, China (Recruiting)
• The Second Affiliated Hospital Zhejiang University School of Medicine. — Hangzhou, Zhejiang, China (Recruiting)
• Ning Bo First Hospital — Ningbo, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Jian' an Wang, PhD, MD

Conditions Aortic Stenosis With Bicuspid Valve