Status:
COMPLETED
Outcomes for Patients With Ascending Aortic Dilation Who Underwent TAVR
Lead Sponsor:
zjq
Conditions:
Transcatheter Aortic Valve Replacement (TAVR)
Ascending Aortic Dilation
Eligibility:
All Genders
50-93 years
Brief Summary
The present study was designed to evaluate the safety of TAVR with a preoperative ascending aortic (AA) diameter ≥ 40 mm. This study also aimed to explore the procedural outcomes and clinical prognose...
Eligibility Criteria
Inclusion
- (1) severe AS patients diagnosed on the recommendation of the European Society of Cardiology/European Association for Cardio-Thoracic Surgery Guidelines (aortic valve area ≤ 1.0 cm²/aortic valve index ≤ 0.6 cm²/m²/peak aortic velocity (Vmax)≥4.0 m/s); (2) patients at intermediate- to high-risk surgical risk or a Society of Thoracic Surgeons risk (STS) score \> 4; (4) patients whose anatomy was evaluated by 3-dimensional (3D) multidetector computed tomography (MDCT) appropriate for TAVR; and (4) patients with severe AS with typical symptoms.
Exclusion
- (1) patients with active endocarditis, acute aortic dissection, or acute myocardial infarction; (2) patients with expectations of life\< 1 year; and (3) patients with inappropriate anatomy evaluated by 3D MDCT.
Key Trial Info
Start Date :
January 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 31 2021
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT07148973
Start Date
January 1 2019
End Date
July 31 2021
Last Update
October 8 2025
Active Locations (1)
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1
the Affiliated Zhongshan Hospital of Dalian University
Dalian, Liaoning, China, 116001