Aortic StenosisNCT06743568
Efficacy of Self-expandable and Balloon-expandable Valves in Patients With Ascending Aortic Dilation
A study testing Transcatheter aortic valve replacement in people with Aortic Stenosis and Ascending Aortic Dilatation, run by China National Center for Cardiovascular Diseases at 3 sites in China.
Trial summary
This study evaluated the efficacy of self-expandable valves and balloon-expandable valves in patients with ascending aortic dilation who undergo 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?
- Transcatheter aortic valve replacement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesChina
- Study dates
- 15 Oct 2024to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 AS defined as an aortic valve area (AVA) of 1cm2 or less or an indexed AVA of 0.6 cm2/m2 or less;
- Evaluation and selection for TAVR by the multidisciplinary heart team;
- Maximum ascending aortic diameter between 45mm and 54mm on preoperative contrast-enhanced computed tomography (CT) scan
- Anatomic suitability for a transfemoral vascular access;
- Life expectancy of more than 12 months;
- Age ≥65 years.
Who cannot join
- Pure aortic regurgitation;
- History of surgical or transcatheter aortic valve replacement (valve in valve);
- History of any aortic surgery;
- Emergent surgery;
- Patients who refused to be randomized or unable to complete regular follow-up.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
National Center for Cardiovascular Disease, China & Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Beijing, Beijing Municipality
Kang An, MD, +86-15801301740, ankang913@126.com
- Not yet recruiting
Fuwai Yunnan Cardiovascular Hospital
Kunming, Yunnan
Wenbin Ouyang, MD, +86-15601827502, victorzhu909@163.com
- Not yet recruiting
Fuwai Shenzhen Hospital
Shenzhen, Guangdong
Shiguo Li, MD, +86-15801178630, drneal@163.com
About this study
This study evaluated the efficacy of self-expandable valves and balloon-expandable valves in patients with ascending aortic dilation who undergo transcatheter aortic valve replacement.
Read the detailed description
Ascending aortic dilation (AAD) is a common feature in patients with aortic stenosis, especially in those with bicuspid aortic valve. According to the 2022 AHA/ACC Guideline for the Diagnosis and Management of Aortic Disease, in patients undergoing surgical aortic valve replacement who have a concomitant AAD with a maximum diameter of ≥45mm, ascending aortic replacement is reasonable when performed by experienced surgeons in a Multidisciplinary Aortic Team (Class 2a, Level B-NR). However, in patients undergoing transcatheter aortic valve replacement, the impact of ascending aortic dilation remains unclear. Therefore, we designed this multicenter prospective randomized controlled trial, aiming to assess the efficacy of self-expandable and balloon-expandable valves in patients with AAD with a maximum diameter of ≥45mm.
- Conditions
- Aortic Stenosis, Ascending Aortic Dilatation
- Being tested
- Transcatheter aortic valve replacement
- Keywords
- Transcatheter aortic valve replacement, Balloon-expandable valve, Self-expandable valve, Aortic stenosis, Ascending aortic dilation
- Medical subject headings
- Aortic Valve Stenosis, 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 replacementDevice
Eligible patients will be randomized 1:1 to self-expandable valve group or balloon-expandable valve group.
| Study group | Role | What they receive |
|---|---|---|
| Self-expandable valve group | Other | Patients who undergo transcatheter aortic valve replacement using self-expandable valves Receives: Device: Transcatheter aortic valve replacement |
| Balloon-expandable valve group | Other | Patients who undergo transcatheter aortic valve replacement using balloon-expandable valves Receives: Device: Transcatheter aortic valve replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device success
(1) freedom from mortality; (2) successful access, delivery of the device, and retrieval of the delivery system; (3) correct positioning of a single prosthetic heart valve into the proper anatomical location; (4) freedom from surgery or intervention related to the device or to a major vascular or access-related, or cardiac structural complication; (5) intended performance of the valve (mean gradient <20mmHg, peak velocity <3m/s, Doppler velocity index ≥0.25, and less than moderate aortic regurgitation).
Measured: Perioperative period
30-day all-cause mortality
30-day all-cause mortality
Measured: 30 days
30-day adverse aortic events
Aortic-related death, aortic dissection, or aortic rupture.
Measured: 30 days
Secondary outcomes (4)
1-year all-cause mortality
1-year all-cause mortality
Measured: 1 year
1-year cardiovascular mortality
1-year cardiovascular mortality
Measured: 1 year
1-year adverse aortic events
Aortic-related death, aortic dissection, or aortic rupture.
Measured: 1 year
Aortic expansion rate≥3mm/year
The aortic expansion rate was defined by the change of AA diameter (before the procedure and at the latest follow-up) divided by the follow-up period.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start15 Oct 2024
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- The present study is a multi-center, open-label, two-arm randomized control trial.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06743568
- Sponsor's protocol ID
- 2024-2486
- Status last verified
- Dec 2024
- First submitted
- 17 Dec 2024
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Self-expandable and Balloon-expandable Valves in Patients With Ascending Aortic Dilation
- ClinicalTrials.gov ID
- NCT06743568
- Acronym / sponsor ID
- 2024-2486
- Conditions
- Aortic Stenosis, Ascending Aortic Dilatation
- Keywords
- Transcatheter aortic valve replacement, Balloon-expandable valve, Self-expandable valve, Aortic stenosis, Ascending aortic dilation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 20 Dec 2024 (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 evaluated the efficacy of self-expandable valves and balloon-expandable valves in patients with ascending aortic dilation who undergo transcatheter aortic valve replacement.
Detailed description
Ascending aortic dilation (AAD) is a common feature in patients with aortic stenosis, especially in those with bicuspid aortic valve. According to the 2022 AHA/ACC Guideline for the Diagnosis and Management of Aortic Disease, in patients undergoing surgical aortic valve replacement who have a concomitant AAD with a maximum diameter of ≥45mm, ascending aortic replacement is reasonable when performed by experienced surgeons in a Multidisciplinary Aortic Team (Class 2a, Level B-NR). However, in patients undergoing transcatheter aortic valve replacement, the impact of ascending aortic dilation remains unclear. Therefore, we designed this multicenter prospective randomized controlled trial, aiming to assess the efficacy of self-expandable and balloon-expandable valves in patients with AAD with a maximum diameter of ≥45mm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The present study is a multi-center, open-label, two-arm randomized control trial.
| Arm | Type | Receives |
|---|---|---|
| Self-expandable valve group | Other | Device: Transcatheter aortic valve replacementPatients who undergo transcatheter aortic valve replacement using self-expandable valves |
| Balloon-expandable valve group | Other | Device: Transcatheter aortic valve replacementPatients who undergo transcatheter aortic valve replacement 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 (6 listed)
- Severe AS defined as an aortic valve area (AVA) of 1cm2 or less or an indexed AVA of 0.6 cm2/m2 or less;
- Evaluation and selection for TAVR by the multidisciplinary heart team;
- Maximum ascending aortic diameter between 45mm and 54mm on preoperative contrast-enhanced computed tomography (CT) scan
- Anatomic suitability for a transfemoral vascular access;
- Life expectancy of more than 12 months;
Key exclusion criteria (5 listed)
- Pure aortic regurgitation;
- History of surgical or transcatheter aortic valve replacement (valve in valve);
- History of any aortic surgery;
- Emergent surgery;
- Patients who refused to be randomized or unable to complete regular follow-up.
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 replacementEligible patients will be randomized 1:1 to self-expandable valve group or balloon-expandable valve group. | Device | Balloon-expandable valve group, Self-expandable valve group |
Primary outcome
Device success
Time frame: Perioperative period
(1) freedom from mortality; (2) successful access, delivery of the device, and retrieval of the delivery system; (3) correct positioning of a single prosthetic heart valve into the proper anatomical location; (4) freedom from surgery or intervention related to the device or to a major vascular or access-related, or cardiac structural complication; (5) intended performance of the valve (mean gradient <20mmHg, peak velocity <3m/s, Doppler velocity index ≥0.25, and less than moderate aortic regurgitation).
30-day all-cause mortality
Time frame: 30 days
30-day all-cause mortality
30-day adverse aortic events
Time frame: 30 days
Aortic-related death, aortic dissection, or aortic rupture.
4 secondary outcomes
1-year all-cause mortality
Time frame: 1 year
1-year cardiovascular mortality
Time frame: 1 year
1-year adverse aortic events
Time frame: 1 year
Aortic expansion rate≥3mm/year
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
- 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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcatheter aortic valve replacement in people with Aortic Stenosis and Ascending Aortic Dilatation, run by China National Center for Cardiovascular Diseases at 3 sites 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 6 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 20 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kang An, MD (+86-15801301740, ankang913@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device success (time frame: Perioperative period). 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?
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 20 Dec 2024.