Aortic StenosisNCT05739253
Changes of Ascending Aortic Diameter in Patients Undergoing Transcatheter Aortic Valve Replacement
An observational study of Aortic Stenosis and Ascending Aortic Dilatation, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Stenosis, Ascending Aortic Dilatation, Bicuspid Aortic Valve
- What is being tested?
- Transcatheter aortic valve replacement
- Type of treatment
- Surgery or procedure
- How many people
- 480 participants
- Where
- 1 siteChina
- Study dates
- 22 Mar 2022to 21 Mar 2025
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The indication to perform transcatheter aortic valve replacement was based on a consensus by the Institutional Heart Team.
Who may be able to join
- 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.
Who cannot join
- Dominant aortic regurgitation;
- History of surgical or transcatheter aortic valve replacement;
- History of aortic surgery;
- Connective tissue disorders.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
National Center for Cardiovascular Disease, China & Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Beijing, Beijing Municipality, 100037
Xiangbin Pan, Dr, 0086-010-88396666, panxiangbin@fuwaihospital.org
Xiangbin Pan, Dr
About this study
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:
- whether the ascending aortic diameter increases or remains stable after transcatheter aortic valve replacement, especially in patients with preoperative ascending aortic dilatation;
- the determinants of postoperative ascending aortic dilatation.
Read the 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.
- Being tested
- Transcatheter aortic valve replacement
- Keywords
- Transcatheter aortic valve replacement, Ascending aortic diameter, Ascending aortic dilatation, Bicuspid aortic valve
- Medical subject headings
- Aortic Valve Stenosis, Bicuspid Aortic Valve Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter aortic valve replacementProcedure or surgery
All patients undergo transfemoral transcatheter aortic valve replacement for aortic stenosis
| Study group | Role | What they receive |
|---|---|---|
| Transfemoral TAVR for AS | Patients undergoing transfemoral transcatheter aortic valve replacement for aortic stenosis Receives: Procedure: Transcatheter aortic valve replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of ascending aortic dilatation
The change of AA diameters (before the procedure and at the latest follow-up) divided by the follow-up period.
Measured: 1-year and 2-year
Secondary outcomes (2)
Rate of all-cause mortality
All-cause mortality during the follow-up period
Measured: 1-year and 2-year
Rate of adverse aortic events
Aortic dissection, aortic rupture, and sudden death not attributable to other causes.
Measured: 1-year and 2-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2023
- Study start22 Mar 2022
- Primary completion21 Mar 2025 (estimated)
- Study completion21 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China National Center for Cardiovascular Diseases
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05739253
- Sponsor's protocol ID
- 2021-1602
- Status last verified
- Feb 2025
- First submitted
- 12 Feb 2023
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
An K, Zhang F, Ouyang W, Pan X. 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. BMC Cardiovasc Disord. 2024 Dec 20;24(1):717. doi: 10.1186/s12872-024-04394-w.
PubMed 39702010