NCT05511792

Down Sizing Strategy (HANGZHOU Solution) vs Standard Sizing Strategy TAVR in Bicuspid Aortic Stenosis (Type 0)

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 206 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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

Detailed description

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.

Conditions

• Aortic Stenosis With Bicuspid Valve

Interventions

Type	Name	Description
PROCEDURE	TAVR for BAV Using Down Sizing with the Evolut Pro platform	Down sizing strategy in Type 0 bicuspid aortic stenosis patients undergoing transcatheter aortic valve replacement with self-expanding valves
PROCEDURE	TAVR for BAV Using Traditional Sizing strategy with the Evolut Pro platform	Traditional sizing strategy in Type 0 bicuspid aortic stenosis patients undergoing transcatheter aortic valve replacement with self-expanding valves

Timeline

• Start date: 2022-06-27
• Primary completion: 2026-07-30
• Completion: 2030-06-30
• First posted: 2022-08-23
• Last updated: 2025-10-03

Locations

15 sites across 1 country: China