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

Launched by CHINA NATIONAL CENTER FOR CARDIOVASCULAR DISEASES · Feb 12, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how the size of the ascending aorta (the large blood vessel connected to the heart) changes in patients who are undergoing a specific heart procedure called transcatheter aortic valve replacement (TAVR). The main goal is to find out if the diameter of the ascending aorta gets bigger or stays the same after the procedure, especially in patients who already have a larger aorta before the surgery. Researchers also want to understand what factors might affect any changes in the aorta after the surgery.

To participate in this study, you need to have severe aortic stenosis, which means your heart's aortic valve is very narrow and not letting enough blood flow through. You should also have symptoms related to this condition and be considered at high risk for traditional heart surgery. However, if you have certain conditions like significant aortic regurgitation (backward blood flow), previous heart valve surgeries, or connective tissue disorders, you may not be eligible. Participants in the trial will be monitored after their TAVR procedure to assess changes in the aorta, helping doctors understand the best ways to care for patients with this heart condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • Dominant aortic regurgitation;
• • History of surgical or transcatheter aortic valve replacement;
• • History of aortic surgery;
• • Connective tissue disorders.