Transcatheter Aortic Valve Replacement (TAVR)NCT07148973
Outcomes for Patients With Ascending Aortic Dilation Who Underwent TAVR
An observational study of Transcatheter Aortic Valve Replacement (TAVR) and Ascending Aortic Dilation, run by zjq at 1 site in China.
Trial summary
The present study was designed to evaluate the safety of TAVR with a preoperative ascending aortic (AA) diameter ≥ 40 mm. This study also aimed to explore the procedural outcomes and clinical prognoses of patients with AAD combined compared to those of patients without AAD combined who underwent TAVR. Read more about this study
- Who is it for?
- Ages 50 to 93 years
- Conditions the study is for
- Transcatheter Aortic Valve Replacement (TAVR), Ascending Aortic Dilation
- What is being tested?
- Transcatheter Aortic Valve Replacement
- Type of treatment
- Surgery or procedure
- How many people
- 101 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 31 Jul 2021
- 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 50 to 93 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients who were diagnosed with severe AS via the TAVR procedure using a self-expanding valve (Venus-A valve, Qiming Med Tech Inc., Hangzhou, China) between January 2019 and July 2021 at our Heart Center were retrospectively enrolled.
Who may be able to join
- (1) severe AS patients diagnosed on the recommendation of the European Society of Cardiology/European Association for Cardio-Thoracic Surgery Guidelines (aortic valve area ≤ 1.0 cm²/aortic valve index ≤ 0.6 cm²/m²/peak aortic velocity (Vmax)≥4.0 m/s); (2) patients at intermediate- to high-risk surgical risk or a Society of Thoracic Surgeons risk (STS) score > 4; (4) patients whose anatomy was evaluated by 3-dimensional (3D) multidetector computed tomography (MDCT) appropriate for TAVR; and (4) patients with severe AS with typical symptoms.
Who cannot join
- (1) patients with active endocarditis, acute aortic dissection, or acute myocardial infarction; (2) patients with expectations of life< 1 year; and (3) patients with inappropriate anatomy evaluated by 3D MDCT.
Trial locations and contacts
1 site in 1 country.
China1 site
the Affiliated Zhongshan Hospital of Dalian University
Dalian, Liaoning, 116001
About this study
Official title: Outcomes for Patients With Ascending Aortic Dilation Who Underwent Transcatheter Aortic Valve Replacement in a Chinese Population
The present study was designed to evaluate the safety of TAVR with a preoperative ascending aortic (AA) diameter ≥ 40 mm. This study also aimed to explore the procedural outcomes and clinical prognoses of patients with AAD combined compared to those of patients without AAD combined who underwent TAVR.
Between January 2019 and July 2021, a total of 186 patients who were diagnosed at a single centre with severe AS underwent the TAVR procedure using a self-expanding valve. The AA diameter was evaluated via 3-dimensional (3D) multidetector computed tomography (MDCT) before TAVR. AAD was defined as a value of AAD ≥ 40 mm.
- Being tested
- Transcatheter Aortic Valve Replacement
- Medical subject headings
- Aneurysm, Ascending Aorta
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
The TAVR surgery mainly involves attaching an artificially-made aortic valve to a special catheter, and then using the catheter to deliver the valve to the affected area and release it. This surgery replaces the original aortic valve with an artificial one, thereby restoring the valve function. Compared with traditional open-chest surgery, it causes less trauma, has lower risks, and enables faster recovery. It is particularly suitable for patients who cannot tolerate open-chest surgery, have poor cardiac function, or are older.
| Study group | Role | What they receive |
|---|---|---|
| AAD | Not described Receives: Procedure: Transcatheter Aortic Valve Replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-Cause Mortality
Measured: 6 month
Mortality
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2025
- Study start1 Jan 2019
- Primary completion31 Jul 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transcatheter Aortic Valve Replacement (TAVR)Studies 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
- Other
- Time perspective
- Other
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- zjq
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, zjq, Affiliated Zhongshan Hospital of Dalian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07148973
- Sponsor's protocol ID
- 2021062
- Status last verified
- Oct 2025
- First submitted
- 22 Aug 2025
- Last updated
- 8 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided