Small Aortic AnnulusNCT06517537
Modified Aortic Root Enlargement Procedure
An observational study of Small Aortic Annulus and Aortic Root Enlargement Procedure, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial summary
This study is a prospective observational clinical trial, in which severe AS patients aged 50-70 years with SAA choose modified ARE or TAVR according to their wishes to investigate the safety and efficacy of modified ARE; Compare the incidence and clinical outcomes of moderate to severe PPM after modified ARE and TAVR… Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Small Aortic Annulus, Aortic Root Enlargement Procedure
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- 15 Jul 2024to 31 Dec 2026
- Phase
- Observational
- 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 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Severe AS patients aged 50-70 years with SAA can choose modified ARE or TAVR according to their wishes to study the safety and effectiveness of modified ARE; Compare the incidence and clinical outcomes of moderate to severe PPM after modified ARE and TAVR surgery; Evaluate the feasibility of postoperative mid valve TAVR and explore the most ideal initial surgical plan for this type of patient from a full lifecycle perspective.
Who may be able to join
- 1) Symptomatic severe AS patients aged 50-70 years who are planning to undergo biological valve replacement (diagnostic criteria for echocardiography are: mean transvalvular pressure gradient ≥ 40mmHg or flow velocity ≥ 4.0 m/s, aortic valve area (AVA) ≤ 0.8 cm2 or iEOA<0.5 cm2/m2) 2) Merge SAA (defined as mean aortic annulus diameter ≤ 23 mm measured by CT)
Who cannot join
- 1) High surgical risk, STS score>8% 2) Severe lesions in multiple coronary arteries requiring PCI or CABG 3) Simultaneous surgical intervention is required for severe mitral and tricuspid valve disease 4) Combining other complex cardiovascular diseases requires simultaneous surgical treatment 6) Combined severe pulmonary arterial hypertension or left ventricular dysfunction (LVEF<40%) 7) Severe respiratory, liver and kidney dysfunction, or other important organ dysfunction combined 8) Concurrent infective endocarditis in active phase 9) Previous history of cardiac surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fuwai Hospital
Beijing, Beijing Municipality
xiaopeng hu, 13621188439
About this study
Official title: The Observational Study of Modified Aortic Root Enlargement Procedure in Aortic Stenosis Patients With Small Aortic Annulus
This study is a prospective observational clinical trial, in which severe AS patients aged 50-70 years with SAA choose modified ARE or TAVR according to their wishes to investigate the safety and efficacy of modified ARE; Compare the incidence and clinical outcomes of moderate to severe PPM after modified ARE and TAVR surgery; Evaluate the feasibility of postoperative mid valve TAVR and explore the most ideal initial surgical plan for this type of patient from a full lifecycle perspective.
Read the detailed description
Small aortic annulus (SAA), which is prevalently observed in patients with severe aortic stenosis (AS), constitutes a significant challenge in treatment and may give rise to post-operative prosthetic valve mismatch (PPM) and an elevated late mortality rate. The optimal approach for treating SAA remains controversial. Transcatheter aortic valve replacement (TAVR) has yielded superior valvular hemodynamic outcomes in patients with SAA; however, the incidence of PPM subsequent to surgery remains considerable. Aortic root enlargement (ARE) represents an effective solution for SAA, but the conventional method of aortic ring enlargement for ARE has restricted efficacy. In 2021, Yang Bo proposed an enhanced ARE approach, where the mitral curtain of the aortic valve was incised in an inverted Y-shape along the left non-coronary junction, enabling the enlargement of the number 3-5 of the aortic ring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ARE | The ARE group underwent modified ARE+AVR surgery | |
| TAVR | TAVR group undergoes routine TAVR surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of moderate PPM and severe PPM after surgery
Prospective collection of all echocardiographic data before surgery and upon discharge, measuring mean aortic valve area (EOA), mean transvalvular pressure gradient, and the degree and type of aortic regurgitation (AR). According to the patient's BSA calculation of iEOA, 0.65-0.85cm2/m2 is diagnosed as moderate PPM, and<0.65cm2/m2 is diagnosed as severe PPM.
Measured: Before discharge, 3 months after surgery, and 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start15 Jul 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Aortic AnnulusStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China National Center for Cardiovascular Diseases
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06517537
- Sponsor's protocol ID
- 2024-2357
- Status last verified
- Jun 2024
- First submitted
- 19 Jul 2024
- Last updated
- 27 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Observational Study of Modified Aortic Root Enlargement Procedure in Aortic Stenosis Patients With Small Aortic Annulus
- ClinicalTrials.gov ID
- NCT06517537
- Acronym / sponsor ID
- 2024-2357
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 15 Jul 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 24 Jul 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 is a prospective observational clinical trial, in which severe AS patients aged 50-70 years with SAA choose modified ARE or TAVR according to their wishes to investigate the safety and efficacy of modified ARE; Compare the incidence and clinical outcomes of moderate to severe PPM after modified ARE and TAVR surgery; Evaluate the feasibility of postoperative mid valve TAVR and explore the most ideal initial surgical plan for this type of patient from a full lifecycle perspective.
Detailed description
Small aortic annulus (SAA), which is prevalently observed in patients with severe aortic stenosis (AS), constitutes a significant challenge in treatment and may give rise to post-operative prosthetic valve mismatch (PPM) and an elevated late mortality rate. The optimal approach for treating SAA remains controversial. Transcatheter aortic valve replacement (TAVR) has yielded superior valvular hemodynamic outcomes in patients with SAA; however, the incidence of PPM subsequent to surgery remains considerable. Aortic root enlargement (ARE) represents an effective solution for SAA, but the conventional method of aortic ring enlargement for ARE has restricted efficacy. In 2021, Yang Bo proposed an enhanced ARE approach, where the mitral curtain of the aortic valve was incised in an inverted Y-shape along the left non-coronary junction, enabling the enlargement of the number 3-5 of the aortic ring
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARE | – | –The ARE group underwent modified ARE+AVR surgery |
| TAVR | – | –TAVR group undergoes routine TAVR surgery |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Severe AS patients aged 50-70 years with SAA can choose modified ARE or TAVR according to their wishes to study the safety and effectiveness of modified ARE; Compare the incidence and clinical outcomes of moderate to severe PPM after modified ARE and TAVR surgery; Evaluate the feasibility of postoperative mid valve TAVR and explore the most ideal initial surgical plan for this type of patient from a full lifecycle perspective.
Key inclusion criteria (1 listed)
- 1) Symptomatic severe AS patients aged 50-70 years who are planning to undergo biological valve replacement (diagnostic criteria for echocardiography are: mean transvalvular pressure gradient ≥ 40mmHg or flow velocity ≥ 4.0 m/s, aortic valve area (AVA) ≤ 0.8 cm2 or iEOA<0.5 cm2/m2) 2) Merge SAA (defined as mean aortic annulus diameter ≤ 23 mm measured by CT)
Key exclusion criteria (1 listed)
- 1) High surgical risk, STS score>8% 2) Severe lesions in multiple coronary arteries requiring PCI or CABG 3) Simultaneous surgical intervention is required for severe mitral and tricuspid valve disease 4) Combining other complex cardiovascular diseases requires simultaneous surgical treatment 6) Combined severe pulmonary arterial hypertension or left ventricular dysfunction (LVEF<40%) 7) Severe respiratory, liver and kidney dysfunction, or other important organ dysfunction combined 8) Concurrent infective endocarditis in active phase 9) Previous history of cardiac surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of moderate PPM and severe PPM after surgery
Time frame: Before discharge, 3 months after surgery, and 1 year after surgery
Prospective collection of all echocardiographic data before surgery and upon discharge, measuring mean aortic valve area (EOA), mean transvalvular pressure gradient, and the degree and type of aortic regurgitation (AR). According to the patient's BSA calculation of iEOA, 0.65-0.85cm2/m2 is diagnosed as moderate PPM, and<0.65cm2/m2 is diagnosed as severe PPM.
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 27 Aug 2024.
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In-vitro Benchmarking of Currently Available Heart Valve Prostheses for Surgical and Percutaneous Treatment of Aortic Stenosis With Small Annulus, Followed by In-vivo Validation
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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.
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 Small Aortic Annulus and Aortic Root Enlargement Procedure, 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 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: looking for participants now, as of the sponsor's last update on 27 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?
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 xiao peng hu, doctor (13621188439, 13621188439@139.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of moderate PPM and severe PPM after surgery (time frame: Before discharge, 3 months after surgery, and 1 year after surgery). 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 27 Aug 2024.