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
- Are there results?
- None posted in the registry
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
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes for Patients With Ascending Aortic Dilation Who Underwent Transcatheter Aortic Valve Replacement in a Chinese Population
- ClinicalTrials.gov ID
- NCT07148973
- Acronym / sponsor ID
- 2021062
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- zjqUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 29 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AAD | – | Procedure: Transcatheter Aortic Valve Replacement |
Who may qualify
- Ages
- 50 to 93 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (1 listed)
- (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.
Key exclusion criteria (1 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcatheter Aortic Valve ReplacementThe 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. | Procedure or surgery | AAD |
Primary outcome
All-Cause Mortality
Time frame: 6 month
Mortality
Time frame: 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2025.
- Individual participant dataSharing planned: Undecided
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REVIVE-FR Registry
Bioprosthetic Valve Failure, Prosthetic Heart Valve Dysfunction
Active, not recruiting
Down Sizing Strategy (HANGZHOU Solution) vs Standard Sizing Strategy TAVR in Bicuspid Aortic Stenosis (Type 0)
Aortic Stenosis With Bicuspid Valve
RecruitingPhase 4
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The ReTAVI Prospective Observational Registry
Structural Valve Deterioration, Structural Valve Degeneration
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transcatheter Aortic Valve Replacement (TAVR) and Ascending Aortic Dilation, run by zjq at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-Cause Mortality (time frame: 6 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2025.