Observing Changes in Ascending Aortic Size After Transcatheter Aortic Valve Replacement in Patients with Severe Aortic Stenosis
Led by China National Center for Cardiovascular Diseases · Updated on 2025-02-10
480
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
This research aims to evaluate how the ascending aortic diameter changes in patients who undergo transcatheter aortic valve replacement TAVR for aortic stenosis. It particularly focuses on whether the diameter increases or remains stable after the procedure, especially in those with preoperative aortic dilatation. The study also seeks to identify factors that influence postoperative aortic dilatation in these patients.
All participants undergo transfemoral TAVR, a procedure where the aortic valve is replaced through an artery in the leg. This observational study includes patients with severe aortic stenosis who are at high risk for traditional surgical valve replacement and who are suitable for this vascular access. The study does not involve additional treatments but monitors patients over time after their TAVR procedure.
Participants will be followed to assess changes in the ascending aortic diameter at one and two years after TAVR. Researchers will also track rates of mortality and adverse aortic events during this period. Data collection includes clinical evaluations and imaging to measure aortic changes and monitor patient health outcomes throughout the study duration, which is planned to continue until March 2025.
CONDITIONS
Brief Title
Changes of Ascending Aortic Diameter in Patients Undergoing Transcatheter Aortic Valve Replacement
Research Team
X
Xiangbin Pan, Dr
K
Kang An, Dr
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Severe aortic stenosis defined as an aortic valve area of 1cm2 or less or an indexed aortic valve area of 0.6cm2/m2 or less
Presence of clinical symptoms defined as a New York Heart Association functional class of 2 or more
High risk of surgical aortic valve replacement
Suitability for a transfemoral vascular access
You will not qualify if you...
Dominant aortic regurgitation
History of surgical or transcatheter aortic valve replacement
History of aortic surgery
Connective tissue disorders
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - 1 day
Participants undergo transfemoral transcatheter aortic valve replacement for aortic stenosis.
1 visit (in-person)
Long-term Monitoring
Duration - 2 years
Participants are monitored to evaluate changes in ascending aortic diameter and assess outcomes post-procedure.
Visits at 1-year and 2-year follow-up
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Published Research Related To This Trial
Blood flow dynamics in the ascending aorta of patients with bicuspid aortic valve before and after transcatheter aortic valve replacement: a computational fluid dynamics study.