HANGZHOU Solution in Bicuspid AS Undergoing TAVR
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Aortic Stenosis
- Aortic Stenosis With Bicuspid Valve
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Double (Participant, Outcomes Assessor)Masking Description: The participants and ourcome assessor are blind to treatment groups.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 60 years and 125 years
- Gender
- Both males and females
Description
Transcatheter aortic valve replacement (TAVR) has emerged as a favorable alternative for severe symptomatic aortic stenosis (AS) patients from low to high surgical risk. BAV patients treated with TAVR had similar 30-day mortality as well as stroke and new pacemaker implantation rates compared to TAV...
Transcatheter aortic valve replacement (TAVR) has emerged as a favorable alternative for severe symptomatic aortic stenosis (AS) patients from low to high surgical risk. BAV patients treated with TAVR had similar 30-day mortality as well as stroke and new pacemaker implantation rates compared to TAV subjects, but carried higher risk of moderate/severe PVL, conversion to surgery and device failure. Event rates significantly decreased with the use of new-generation devices, but TAVR still showed better procedural results in TAV compared to BAV. Clinical experience in China suggests bicuspid aortic valves and heavy calcium burden are more common among TAVR candidates. Morphological characteristics at supra-annular structure (from annulus to the level of sinotubular junction) are quite complex in bicuspid AS, especially concomitant with heavily calcified leaflets. Because only two leaflet hinge points provide the definition of the annulus plane, current CT-based annulus measurements might not be accurate under these circumstances. From previous single center clinical practice, "waist sign" above the annulus during balloon aortic valvuloplasty in TAVR was often observed in patients with bicuspid AS, indicating that the supra-annular structure may serve a key role in anchoring the THV. Therefore, we developed a balloon based supra-annular sizing strategy (Hangzhou Solution) for SEV implantation in bicuspid AS. From our single center experience, the device success rate and pacemaker implantation rate were relatively low. The aim of this study is to compare supra-annular sizing and THV implantation technique (Hangzhou solution) versus annular sizing and THV implantation technique (control group) in bicuspid aortic stenosis (AS) patients undergoing transcatheter aortic valve replacement (TAVR) with self-expanding valves (SEVs).
Tracking Information
- NCT #
- NCT04722796
- Collaborators
- Fujian Medical University Union Hospital
- Venus MedTech (HangZhou) Inc.
- First Affiliated Hospital Bengbu Medical College
- Chinese PLA General Hospital
- Tianjin Chest Hospital
- Xiamen University Affiliated Cardiovascular Hospital
- Guangdong People's Hospital
- The Affiliated Hospital of Qingdao University
- Second Affiliated Hospital of Nanchang University
- Zhengzhou Cardiovascular Hospital
- The First Affiliated Hospital of Zhengzhou University
- Hennan Provincial Chest Hospital
- Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
- The First Affiliated Hospital of Nanchang University
- Ning Bo First Hospital
- Northern Jiangsu Province People's Hospital
- Central South University
- Shanxi cardiovascular hospital
- Investigators
- Study Chair: Jian'an Wang, PhD, MD 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China