ClinicalTrials.gg
RecruitingNCT05739253Updated Feb 10, 2025

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

An observational study in Aortic Stenosis, Ascending Aortic Dilatation and Bicuspid Aortic Valve, sponsored by China National Center for Cardiovascular Diseases. Recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2025-02-10.

Sponsored by China National Center for Cardiovascular Diseases · Observational

From the registry’s dates

  • Primary completion was expected by Mar 2025, 1 year 7 months ago, but the record still lists the study as recruiting.
  • Started Mar 2022; still recruiting 4 years 7 months later.

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
480
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 67 studies in Aortic Valve Stenosis with a site in China — 41 open to participants now, 49 under way, 3 of them phase 3. Aortic Valve Stenosis · China.

Planned enrollment
10th of 20
480 · median 465
Started
2022
with 5 others
Observational
20 of 67
14 open now
Primary completion
2025-03
later than 15 of 48 live
Registered
31st of 67
by date
Lead sponsor
6 of 67
China National Center for Cardiovascular Diseases

Among the 67 studies in Aortic Valve Stenosis with a site in China, this one is the 10th largest by planned enrollment of the 20 observational ones that give a count, is one of 6 that started in 2022, is one of 20 observational ones, reaches primary completion later than 15 of the 48 other live ones, and was the 31st registered.

Aortic Valve Stenosis

1,025 studies on the registry are indexed under Aortic Valve Stenosis; 293 are open to participants now.

Browse Aortic Valve Stenosis studies →

Open to participants now

41 of the 67 studies in Aortic Valve Stenosis with a site in China are open now. Recruiting first, the newest first:

36 more — sign in →

All 41 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 209 Aortic Valve Stenosis studies recruiting now, 163 (78%) set no upper age limit and 9 (4%) stop at 75 or younger; 25 take children under 18; 14 take healthy volunteers.

This study: all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 67 studies in Aortic Valve Stenosis with a site in China, or all of them as a file.
02

Study 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.
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.

03

Conditions studied

  • Aortic Stenosis
  • Ascending Aortic Dilatation
  • Bicuspid Aortic Valve

Keywords

  • Transcatheter aortic valve replacement
  • Ascending aortic diameter
  • Ascending aortic dilatation
  • Bicuspid aortic valve
04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

The indication to perform transcatheter aortic valve replacement was based on a consensus by the Institutional Heart Team.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 functional class of 2 or more;
  • High risk of surgical aortic valve replacement;
  • Suitability for a transfemoral vascular access.

Exclusion criteria

Exclusion Criteria:

  • Dominant aortic regurgitation;
  • History of surgical or transcatheter aortic valve replacement;
  • History of aortic surgery;
  • Connective tissue disorders.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
480 participants (estimated)
Patient registry
No

Groups and cohorts

  • Transfemoral TAVR for AS

    Patients undergoing transfemoral transcatheter aortic valve replacement for aortic stenosis

    Procedure: Transcatheter aortic valve replacement

Interventions

  • ProcedureTranscatheter aortic valve replacement

    All patients undergo transfemoral transcatheter aortic valve replacement for aortic stenosis

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1-year and 2-year

Secondary outcomes

  1. Rate of all-cause mortality

    All-cause mortality during the follow-up period

    Time frame: 1-year and 2-year

  2. Rate of adverse aortic events

    Aortic dissection, aortic rupture, and sudden death not attributable to other causes.

    Time frame: 1-year and 2-year

07

Study locations

1 of 1 sites recruiting
  • National Center for Cardiovascular Disease, China & Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
    Beijing, Beijing 100037, China
    Recruiting
    • Xiangbin Pan, Dr · Contactpanxiangbin@fuwaihospital.org · 0086-010-88396666
    • Xiangbin Pan, Dr · Principal investigator
    • Kang An, Dr · Sub investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2022 (actual). Primary completion is estimated for Mar 2025, 35 months after the start.

Of 205 non-industry observational studies under Aortic Valve Stenosis, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 120. This study's planned 35 months is below that.

Counting every sponsor, half of 242 studies reached it within 42 months; a quarter within 23 and three quarters within 86.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 12, 2023
First posted
Feb 22, 2023
StartActual
Mar 22, 2022
Primary completionEst.
Mar 21, 2025
CompletionEst.
Mar 21, 2025
Last update
Feb 10, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05739253
Responsible party
Sponsor
First posted
Feb 22, 2023
Start date
Mar 22, 2022
Primary completion
Mar 21, 2025 (estimated)
Completion
Mar 21, 2025 (estimated)
Last update
Feb 10, 2025

Study contacts

Xiangbin Pan, Dr
Contact
panxiangbin@fuwaihospital.org
0086-010-88396666
Kang An, Dr
Contact
ankang913@126.com
0086-15801301740

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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