Actively Recruiting

All Genders
ID05739253

Changes of Ascending Aortic Diameter in Patients Undergoing Transcatheter Aortic Valve Replacement

Led by China National Center for Cardiovascular Diseases · Updated on 2025-02-10

480

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

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

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • Dominant aortic regurgitation
  • History of surgical or transcatheter aortic valve replacement
  • History of aortic surgery
  • Connective tissue disorders

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

Trial Site Locations

Total: 1 location

1

National Center for Cardiovascular Disease, China & Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

Beijing, Beijing Municipality, China, 100037

Actively Recruiting

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Research Team

X

Xiangbin Pan, Dr

K

Kang An, Dr

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.

Kang An, Fengwen Zhang, Wenbin Ouyang...

https://pubmed.ncbi.nlm.nih.gov/39702010