Aortic Stenosis, Ascending Aortic Dilatation, Bicuspid Aortic Valve
Conditions
Keywords
Transcatheter aortic valve replacement, Ascending aortic diameter, Ascending aortic dilatation, Bicuspid aortic valve
Brief summary
The goal of this observational study is to assess the changes of ascending aortic diameter in patients undergoing transcatheter aortic valve replacement. The main questions it aims to answer are: 1. whether the ascending aortic diameter increases or remains stable after transcatheter aortic valve replacement, especially in patients with preoperative ascending aortic dilatation; 2. the determinants of postoperative ascending aortic dilatation.
Detailed description
Ascending aortic (AA) dilatation occurs frequently in patients with aortic stenosis (AS). For patients who are candidates for transcatheter aortic valve replacement (TAVR), simultaneous repair of a dilatated AA is technically difficult. As the indications for TAVR have extended to low-risk patients and patients with bicuspid aortic valve , AA dilatation should be considered as a new criterion to refine risk stratification in patients undergoing TAVR. In this observational study, we aim to evaluate the changes of AA diameters and identify the determinants post-TAVR AA dilatation.
Interventions
PROCEDURETranscatheter aortic valve replacement
All patients undergo transfemoral transcatheter aortic valve replacement for aortic stenosis
Sponsors
China National Center for Cardiovascular Diseases
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of ascending aortic dilatation | 1-year and 2-year | The change of AA diameters (before the procedure and at the latest follow-up) divided by the follow-up period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of all-cause mortality | 1-year and 2-year | All-cause mortality during the follow-up period |
| Rate of adverse aortic events | 1-year and 2-year | Aortic dissection, aortic rupture, and sudden death not attributable to other causes. |
Countries
China
Contacts
Primary ContactXiangbin Pan, Dr
Backup ContactKang An, Dr
Outcome results
None listed