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
Transcatheter aortic valve replacement (TAVR) has emerged as a favorable alternative for severe symptomatic aortic stenosis (AS) patients of all surgical risk profiles. Patients with bicuspid aortic valve (BAV) underwent TAVR had similar 30-day mortality as well as stroke and new pacemaker implantation rates compared to tricuspid aortic valve (TAV) subjects, but carried higher risk of moderate/severe perivalvular leakage (PVL), conversion to surgery and device failure. Clinical experience in China suggests BAV and heavy calcium burden are more common among TAVR candidates than US/EU cohorts. Morphological characteristics at supra-annular structure (from annulus to the level of sinotubular junction) are quite complex in BAV, especially concomitant with heavily calcified leaflets. From our previous single center clinical practice, "waist sign" above the annulus during balloon aortic valvuloplasty in TAVR was often observed in patients with bicuspid AS, suggesting that supra-annular structures are the most constrained portion of BAV anatomy where the prosthesis anchors and seals. Therefore, we developed a balloon based supra-annular sizing strategy for self-expanding valves implantation in BAV and the device failure rate as well as pacemaker implantation rates were relatively low as shown in previous cohort study. Several other studies have also achieved successful outcomes associated with device "down sizing" (using a device smaller than that recommended by annular sizing). The aim of this study is to compare "down sizing"strategy (experimental group) versus annular sizing strategy (control group) in BAV patients undergoing TAVR with self-expanding valves.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
206
Down sizing strategy in Type 0 bicuspid aortic stenosis patients undergoing transcatheter aortic valve replacement with self-expanding valves
Traditional sizing strategy in Type 0 bicuspid aortic stenosis patients undergoing transcatheter aortic valve replacement with self-expanding valves
Fujian Provincial Hospital, Affiliated to Fuzhou University
Fuzhou, Fujian, China
RECRUITINGXiamen Cardiovascular Hospital Xiamen University
Composite endpoint of Clinical Event Rate of Device Success (VARC-3), Free of pacemaker implantation, and Free of new onset complete left bundle branch block at 1 month
Composite endpoint of Device Success (VARC-3), Free of pacemaker implantation, and Free of new onset complete left bundle branch block at 1 month
Time frame: 1 month after index procedure
New onset complete left bundle branch block
New onset complete left bundle branch block with QRS ≥120ms at 1 month
Time frame: 1 month after index procedure
Permanent pacemaker implantation
Permanent pacemaker implantation within one month
Time frame: 1 month after index procedure
Device success Rate
Device success per VARC-3 definition
Time frame: 1 month after index procedure
More than (≥) moderate regurgitation
More than (≥) moderate regurgitation on echocardiography at 1month
Time frame: 1 month after index procedure
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Xiamen, Fujian, China
Lanzhou University First Hospital
Lanzhou, Gansu, China
RECRUITINGNanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China
RECRUITINGSUN YAT-SEN MEMORIAL HOSPITAL SUN YAT-SEN University
Guangzhou, Guangdong, China
RECRUITINGYulin First People's Hospital
Yulin, Guangxi, China
RECRUITINGZhengzhou Seventh People's Hospital
Zhengzhou, Henan, China
RECRUITINGThe Second XIANGYA Hospital Of Central South University
Changsha, Hunan, China
RECRUITINGThe First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
RECRUITINGFirst Affiliated Hospital of Xi 'an Jiaotong University
Xi'an, Shaanxi, China
RECRUITING...and 5 more locations