Aortic StenosisNCT06009588
Comparison of Self- and Balloon-expandable Valves in Patients With Ascending Aortic Dilation Undergoing Transcatheter Aortic Valve Replacement: The AAD-CHOICE
A study testing self-expandable valves and balloon-expandable valves in people with Aortic Stenosis and Ascending Aortic Dilatation, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial summary
This study aimed at comparing the performance of self-expandable valves versus balloon-expandable valves in patients with ascending aortic dilation undergoing transcatheter aortic valve replacement. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Aortic Stenosis, Ascending Aortic Dilatation
- What is being tested?
- self-expandable valves and balloon-expandable valves
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 31 Aug 2023to 30 Aug 2026
- Phase
- Interventional
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Severe aortic stenosis;
- Transfemoral access;
- Preoperative aortic CT suggesting maximum ascending aortic diameter ≥45mm and <55mm;
- Anticipated life expectancy >1 year;
- Age ≥ 65 years.
Who cannot join
- Dominant aortic regurgitation,;
- A history of SAVR or TAVR;
- A history of aortic surgery;
- Emergent TAVR.
Trial locations and contacts
1 site in 1 country.
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
This study aimed at comparing the performance of self-expandable valves versus balloon-expandable valves in patients with ascending aortic dilation undergoing transcatheter aortic valve replacement.
Read the detailed description
Ascending aortic (AA) dilation is a common feature in patients with aortic stenosis (AS), especially in those with bicuspid aortic valve (BAV). For patients undergoing surgical aortic valve replacement (SAVR), current guidelines recommend concomitant aortic repair or replacement if the diameter of AA exceeds 45mm to avoid aortic dissection or rupture.
Transcatheter aortic valve replacement (TAVR) has profoundly changed the clinical management of AS patients who cannot tolerate SAVR. For patients who are candidates for TAVR, simultaneous repair of a dilated AA can be technically difficult. The safety and feasibility of the procedure and the fate of AA after the procedure in these patients remain unclear. Moreover, there are limited data comparing the performance of self-expandable valves versus balloon-expandable valves in these patients. The aim of the present study is to evaluate the impact of type of transcatheter heart valves on intra-procedural device success and post-procedural AA progression in patients with dilated AA (≥45mm) undergoing TAVR.
- Conditions
- Aortic Stenosis, Ascending Aortic Dilatation
- Being tested
- self-expandable valves, balloon-expandable valves
- Keywords
- Transcatheter aortic valve replacement, Self-expandable valve, Balloon-expandable valve
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self-expandable valvesDevice
patients undergoing TAVR use self-expandable valves
balloon-expandable valvesDevice
patients undergoing TAVR use balloon-expandable valves
| Study group | Role | What they receive |
|---|---|---|
| Self-expandable valve group | Experimental | Patients using self-expandable valves Receives: Device: self-expandable valves |
| Balloon-expandable valve group | Experimental | Patients using balloon-expandable valves Receives: Device: balloon-expandable valves |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day all-cause mortality
all-cause mortality within 30 days after TAVR procedure
Measured: 30 days after TAVR procedure
30-day adverse aortic events
aortic death, aortic dissection, or aortic rupture
Measured: 30 days after TAVR procedure
The rate of device success
Device success is defined as following:
- Technical success (Freedom from mortality; Successful access, delivery of the device, and retrieval of the delivery system; Correct positioning of a single prosthetic heart valve into the proper anatomical location; Freedom from surgery or intervention related to the device or to a major vascular or access-related, or cardiac structural complication)
- Freedom from mortality
- Freedom from surgery or intervention related to the device or to a major vascular or access-related or cardiac structural complication
- Intended performance of the valve (mean gradient <20 mmHg, peak velocity <3 m/s, Doppler velocity index $0.25, and less than moderate aortic regurgitation)
Measured: 30 days
Secondary outcomes (5)
1-year all-cause mortality
all-cause mortality
Measured: 1 year after TAVR procedure
1-year cardiovascular mortality
Related to heart failure, cardiogenic shock, bioprosthetic valve dysfunction, myocardial infarction, stroke, thromboembolism, bleeding, tamponade, vascular complication, arrhythmia or conduction system disturbances, cardiovascular infection (e.g. mediastinitis, endocarditis), or other clear cardiovascular cause
Measured: 1 year after TAVR procedure
1-year adverse aortic events
aortic death, aortic dissection, or aortic rupture
Measured: 1 year after TAVR procedure
Ascending aortic diameter expansion rate ≥3mm/year
Expansion rate was calculated as the change of ascending aortic diameters (before the procedure and at the latest follow-up) divided by the follow-up period.
Measured: 1 year after TAVR procedure
Hospitalization (or re-hospitalization)
Any admission after the index hospitalization or study enrolment to an inpatient unit or hospital ward for ≥24 h, including an emergency department stay.
Hospitalizations planned for pre-existing conditions are excluded unless there is worsening of the baseline condition. Visits to urgent care centres or emergency departments <24 h may also be included if substantive intensification of therapy changes (e.g. heart failure episodes) are enacted (e.g. intravenous diuretics, significant increases in drug therapy dosages or addition of new pharmacotherapy agents)
Measured: 1 year after TAVR procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2023
- Study start31 Aug 2023
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- More trials run by China National Center for Cardiovascular DiseasesThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Self-expandable valve group vs. Balloon-expandable valve group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Xiangbin Pan, MD, Principal investigator, Department of Structural Heart Disease, National Center for Cardiovascular Disease, China & Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06009588
- Sponsor's protocol ID
- 2023-2024
- Status last verified
- Aug 2024
- First submitted
- 12 Aug 2023
- Last updated
- 5 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
VARC-3 WRITING COMMITTEE:; Genereux P, Piazza N, Alu MC, Nazif T, Hahn RT, Pibarot P, Bax JJ, Leipsic JA, Blanke P, Blackstone EH, Finn MT, Kapadia S, Linke A, Mack MJ, Makkar R, Mehran R, Popma JJ, Reardon M, Rodes-Cabau J, Van Mieghem NM, Webb JG, Cohen DJ, Leon MB. Valve Academic Research Consortium 3: Updated Endpoint Definitions for Aortic Valve Clinical Research. J Am Coll Cardiol. 2021 Jun 1;77(21):2717-2746. doi: 10.1016/j.jacc.2021.02.038. Epub 2021 Apr 19.
PubMed 33888385An K, Zhang F, Ouyang W, Li S, Pan X. Protocol for a randomized controlled trial for comparison of self- and balloon-expandable valves in patients with Ascending Aortic Dilation Undergoing Transcatheter Aortic Valve Replacement (AAD-CHOICE). Trials. 2025 Nov 28;27(1):1. doi: 10.1186/s13063-025-09233-7.
PubMed 41316413
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Self- and Balloon-expandable Valves in Patients With Ascending Aortic Dilation Undergoing Transcatheter Aortic Valve Replacement: The AAD-CHOICE
- ClinicalTrials.gov ID
- NCT06009588
- Acronym / sponsor ID
- 2023-2024
- Conditions
- Aortic Stenosis, Ascending Aortic Dilatation
- Keywords
- Transcatheter aortic valve replacement, Self-expandable valve, Balloon-expandable valve
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 31 Aug 2023 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 24 Aug 2023 (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.
This study aimed at comparing the performance of self-expandable valves versus balloon-expandable valves in patients with ascending aortic dilation undergoing transcatheter aortic valve replacement.
Detailed description
Ascending aortic (AA) dilation is a common feature in patients with aortic stenosis (AS), especially in those with bicuspid aortic valve (BAV). For patients undergoing surgical aortic valve replacement (SAVR), current guidelines recommend concomitant aortic repair or replacement if the diameter of AA exceeds 45mm to avoid aortic dissection or rupture.
Transcatheter aortic valve replacement (TAVR) has profoundly changed the clinical management of AS patients who cannot tolerate SAVR. For patients who are candidates for TAVR, simultaneous repair of a dilated AA can be technically difficult. The safety and feasibility of the procedure and the fate of AA after the procedure in these patients remain unclear. Moreover, there are limited data comparing the performance of self-expandable valves versus balloon-expandable valves in these patients. The aim of the present study is to evaluate the impact of type of transcatheter heart valves on intra-procedural device success and post-procedural AA progression in patients with dilated AA (≥45mm) undergoing TAVR.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Self-expandable valve group vs. Balloon-expandable valve group
| Arm | Type | Receives |
|---|---|---|
| Self-expandable valve group | Experimental | Device: self-expandable valvesPatients using self-expandable valves |
| Balloon-expandable valve group | Experimental | Device: balloon-expandable valvesPatients using balloon-expandable valves |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Severe aortic stenosis;
- Transfemoral access;
- Preoperative aortic CT suggesting maximum ascending aortic diameter ≥45mm and <55mm;
- Anticipated life expectancy >1 year;
- Age ≥ 65 years.
Key exclusion criteria (4 listed)
- Dominant aortic regurgitation,;
- A history of SAVR or TAVR;
- A history of aortic surgery;
- Emergent TAVR.
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 |
|---|---|---|
| self-expandable valvespatients undergoing TAVR use self-expandable valves | Device | Self-expandable valve group |
| balloon-expandable valvespatients undergoing TAVR use balloon-expandable valves | Device | Balloon-expandable valve group |
Primary outcome
30-day all-cause mortality
Time frame: 30 days after TAVR procedure
all-cause mortality within 30 days after TAVR procedure
30-day adverse aortic events
Time frame: 30 days after TAVR procedure
aortic death, aortic dissection, or aortic rupture
The rate of device success
Time frame: 30 days
Device success is defined as following: 1. Technical success (Freedom from mortality; Successful access, delivery of the device, and retrieval of the delivery system; Correct positioning of a single prosthetic heart valve into the proper anatomical location; Freedom from surgery or intervention related to the device or to a major vascular or access-related, or cardiac structural complication) 2. Freedom from mortality 3. Freedom from surgery or intervention related to the device or to a major vascular or access-related or cardiac structural complication 4. Intended performance of the valve (mean gradient <20 mmHg, peak velocity <3 m/s, Doppler velocity index $0.25, and less than moderate aortic regurgitation)
5 secondary outcomes
1-year all-cause mortality
Time frame: 1 year after TAVR procedure
1-year cardiovascular mortality
Time frame: 1 year after TAVR procedure
1-year adverse aortic events
Time frame: 1 year after TAVR procedure
Ascending aortic diameter expansion rate ≥3mm/year
Time frame: 1 year after TAVR procedure
Hospitalization (or re-hospitalization)
Time frame: 1 year after TAVR procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2024.
- Background: PubMed 33888385VARC-3 WRITING COMMITTEE:; Genereux P, Piazza N, Alu MC, Nazif T, Hahn RT, Pibarot P, Bax JJ, Leipsic JA, Blanke P, Blackstone EH, Finn MT, Kapadia S, Linke A, Mack MJ, Makkar R, Mehran R, Popma JJ, Reardon M, Rodes-Cabau J, Van Mieghem NM, Webb JG, Cohen DJ, Leon MB. Valve Academic Research Consortium 3: Updated Endpoint Definitions for Aortic Valve Clinical Research. J Am Coll Cardiol. 2021 Jun 1;77(21):2717-2746. doi: 10.1016/j.jacc.2021.02.038. Epub 2021 Apr 19.
- Derived from this study: PubMed 41316413An K, Zhang F, Ouyang W, Li S, Pan X. Protocol for a randomized controlled trial for comparison of self- and balloon-expandable valves in patients with Ascending Aortic Dilation Undergoing Transcatheter Aortic Valve Replacement (AAD-CHOICE). Trials. 2025 Nov 28;27(1):1. doi: 10.1186/s13063-025-09233-7.
- Individual participant dataSharing planned: No
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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.
Xiangbin Pan, MD principal investigator
Department of Structural Heart Disease, National Center for Cardiovascular Disease, China & Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing self-expandable valves and balloon-expandable valves in people with Aortic Stenosis and Ascending Aortic Dilatation, run by China National Center for Cardiovascular Diseases 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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 5 Aug 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kang An, MD (0085-15801301740, ankang913@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day all-cause mortality (time frame: 30 days after TAVR procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06009588, which also lists 2 linked publications.
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 5 Aug 2024.