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
Status: Recruiting
Location: See all (15) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
To compare down sizing strategy versus annular sizing strategy technique (control group) in Type 0 bicuspid aortic stenosis (AS) patients undergoing transcatheter aortic valve replacement (TAVR) with self-expanding valves (SEVs): a randomized superiority trial
Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Healthy Volunteers: f
View:
• Age ≥ 65 years;
• 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;
• 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;
• NYHA classification ≥ II;
• Type 0 (Sievers classification) by MDCT;
• Perimeter-derived annulus diameter ranges from 20.0 mm to 26.0 mm;
• Candidate for 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.
Locations
Other Locations
China
The Second XIANGYA Hospital Of Central South University
RECRUITING
Changsha
Fujian Provincial Hospital, Affiliated to Fuzhou University
RECRUITING
Fuzhou
Nanfang Hospital of Southern Medical University
RECRUITING
Guangzhou
SUN YAT-SEN MEMORIAL HOSPITAL SUN YAT-SEN University
RECRUITING
Guangzhou
The Second Affiliated Hospital Zhejiang University School of Medicine.
RECRUITING
Hangzhou
Lanzhou University First Hospital
RECRUITING
Lanzhou
The First Affiliated Hospital of Nanchang University
RECRUITING
Nanchang
Ning Bo First Hospital
RECRUITING
Ningbo
Affiliated Hospital of Qingdao University
RECRUITING
Qingdao
Qingdao Municipal Hospital
RECRUITING
Qingdao
Xinjiang Uygur Autonomous Region People's Hospital
RECRUITING
Ürümqi
First Affiliated Hospital of Xi 'an Jiaotong University
RECRUITING
Xi'an
Xiamen Cardiovascular Hospital Xiamen University
RECRUITING
Xiamen
Yulin First People's Hospital
RECRUITING
Yulin
Zhengzhou Seventh People's Hospital
RECRUITING
Zhengzhou
Contact Information
Primary
Jian' an Wang, PhD, MD
wja@zju.edu.cn
+86057187783777
Time Frame
Start Date:2022-06-27
Estimated Completion Date:2030-06-30
Participants
Target number of participants:206
Treatments
Experimental: TAVR with down sizing strategy
Balloon sizing will be used during procedural. Pre-dilation with balloon size just below the annular size. 20mm for annular size of 20-23mm. 23mm for annular size 23-26mm.~Waist sign with less than mild contrast regurgitation: Evolut PRO Valve one size smaller than manufacturer recommendation and Target implant depth 0-3mm.~No waist sign and/or contrast regurgitation or unable to finish supra-annular sizing: Evolut PRO annular sizing (per manufacturer recommendation) with implant depth 0-3mm.
Active_comparator: TAVR with standard sizing strategy
Pre-dilation with balloon size just below the annular size. 20mm for annular size of 20-23mm. 23mm for annular size 23-26mm.~The prosthesis size of Evolut PRO will be chosen based on manufacturer recommendation. The target implant depth will be 0-3mm.