Ignite Creation Date:
2024-05-06 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04722796
Status:
RECRUITING
Last Update Posted:
2021-06-02
First Post:
2021-01-20
Brief Title:
HANGZHOU Solution in Bicuspid AS Undergoing TAVR
Sponsor:
Second Affiliated Hospital School of Medicine Zhejiang University
Organization:
Second Affiliated Hospital School of Medicine Zhejiang University
Study Overview
Official Title:
HANGZHOU Solution for Patients With Bicuspid Aortic Stenosis Undergoing Transcatheter Aortic Valve Replacement by Using Supra-annular Structure Based Balloon Sizing Strategy
Status:
RECRUITING
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 a randomized superiority trial
Detailed 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 subjects but carried higher risk of moderatesevere 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None