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

HANGZHOU Solution for Patients With Bicuspid Aortic Stenosis Undergoing Transcatheter Aortic Valve Replacement by Using Supra-annular Structure Based Balloon Sizing Strategy

This study tests two different ways to replace aortic valves in people with bicuspid aortic stenosis to see which method works better and has fewer complications.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 508 (estimated)
• Ages: 60 Years and up
• Sex: All
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (Academic / other)
• Locations: 18 sites (Bengbu, Anhui and 17 other locations)
• Trial ID: NCT04722796 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are patients aged 60 years and older with severe bicuspid aortic stenosis who are at high surgical risk.

Not a fit: Patients with contraindications for self-expanding bioprosthetic aortic valve deployment or significant blood disorders may 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 with bicuspid aortic stenosis.

How similar studies have performed: While there have been studies on TAVR techniques, the specific approach of supra-annular sizing in bicuspid aortic stenosis is relatively novel and has not been extensively tested.

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.

Where this trial is running

Bengbu, Anhui and 17 other locations

• 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)
• Xiamen University Affiliated Cardiovascular Hospital — Xiamen, Fujian, China (Not_yet_recruiting)
• Guangdong People's Hospital — Guangzhou, Guangdong, China (Not_yet_recruiting)
• Zhengzhou Cardiovascular Hospital — Zhengzhou, Henan, China (Not_yet_recruiting)
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (Not_yet_recruiting)
• Hennan Provincial Chest Hospital — Zhengzhou, Hennan, China (Not_yet_recruiting)
• Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)
• The Second XIANGYA Hospital Of Central South University — Changsha, Hunan, China (Not_yet_recruiting)
• Northern Jiangsu People's Hospital — Yangzhou, Jiangsu, China (Not_yet_recruiting)
• The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (Not_yet_recruiting)
• The Second Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (Not_yet_recruiting)
• The Affiliated Hospital of Qingdao University — Qingdao, Shandong, China (Not_yet_recruiting)
• Shanxi Cardiovascular Hospital — Taiyuan, Shanxi, China (Not_yet_recruiting)
• tianjin Chest Hospital — Tianjing, Tianjing, China (Not_yet_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; Aortic Stenosis With Bicuspid Valve; Transcatheter aortic valve replacement; Aortic Stenosis with Bicuspid Valve; supra-annular sizing