Comparing two techniques for aortic valve replacement in patients with bicuspid aortic stenosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to compare two different techniques for transcatheter aortic valve replacement (TAVR) in patients with bicuspid aortic stenosis. The study will evaluate the effectiveness of a new supra-annular sizing approach, known as the Hangzhou solution, against the traditional annular sizing method. Participants will be randomly assigned to one of the two groups to assess outcomes such as device success rates and complications. The trial is designed to improve the precision of valve implantation in patients with complex anatomical features associated with bicuspid aortic valves.

Why it matters

Who can join: the full rules

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.

Where it's running

• Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
  Wuhan, Hubei, China Recruiting
• The Second Affiliated Hospital Zhejiang University School of Medicine.
  Hangzhou, Zhejiang, China Recruiting
• Ning Bo First Hospital
  Ningbo, Zhejiang, China Recruiting
• The First affiliated hospital of bengbu medical college
  Bengbu, Anhui, China Not yet recruiting
• The General Hospital of the People's Liberation Army
  Beijing, Beijing Municipality, China Not yet recruiting
• Fujian Medical University Union Hospital
  Fuzhou, Fujian, China Not yet recruiting

Study contacts

• Study coordinator: Jian'an Wang, PhD, MD
• Email: wja@zju.edu.cn
• Phone: +86057187783777

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.