Aortic Regurgitation DiseaseNCT06835946
Impact of Anesthesia, Positive Pressure Ventilation and Modality of Imaging on the Echocardiographic Assessment of the Severity of Aortic Regurgitation
An observational study of Aortic Regurgitation Disease and Aortic Insufficiency, run by University of Liege at 1 site in Belgium.
Trial summary
The goal of this observational study is to assess the impact of imaging modality (trans-thoracic echo (TTE) vs trans-esophageal echo (TEE)), anesthesia and positive pressure ventilation on the grading of aortic insufficiency. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Regurgitation Disease, Aortic Insufficiency
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Mar 2025to 1 Apr 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients scheduled for cardiac surgery at the "Centre Hospitalier Universitaire de Liège" with any grade of known preoperative aortic regurgitation.
Who may be able to join
- Known aortic regurgitation of any grade
- Scheduled for a cardiac surgery procedure during which a trans-esophageal echo is planned.
Who cannot join
- Non sinus rhythm
- Mitral regurgitation more than mild.
- Pre-operative critical state (according to the definition of the EuroSCORE II)
- Presence of a prosthetic aortic valve
- Contra-indication to trans-esophageal echo
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Centre Hospitalier Universitaire de Liège
Liège, 4000
Alan Houven, MD, ahouben@chuliege.be
About this study
Official title: Prospective Single-center Observational Trial Aimed at Investigating the Effect of General Anesthesia, Positive Pressure Ventilation and Change of Imaging Modality From Transthoracic Echo to Transesophageal Echo on the Grading of the Severity of Aortic Regurgitation.
The goal of this observational study is to assess the impact of imaging modality (trans-thoracic echo (TTE) vs trans-esophageal echo (TEE)), anesthesia and positive pressure ventilation on the grading of aortic insufficiency.
Patients scheduled for cardiac surgery and in whom a TEE is going to be performed intra-operatively will be enrolled. The grading of the aortic insufficiency will be compared between a TTE performed immediately before the induction of general anesthesia end the TEE performed after induction of general anesthesia.
- Conditions
- Aortic Regurgitation Disease, Aortic Insufficiency
- Medical subject headings
- Aortic Valve Insufficiency
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 |
|---|---|---|
| Adult patients scheduled for cardiac surgery with previously known aortic regurgitation of any grade | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance between the grade of aortic regurgitation on pre-operative TTE and intra-operative TEE
The preoperative TTE will be performed immediately before anesthesia induction. The intra-operative TEE will be performed after anesthesia induction.
Five measurements will be used to grade the aortic regurgitation including three major (vena contracta, ration between the width of the aortic regurgitation and the left ventricular outflow tract, and the pressure half time) and two minor (diastolic flow reversal in descending aorta and effective regurgitation orifice area assessed by the proximal isovelocity surface area method).
The images required to perform these measurements will be acquired three times on non contiguous cardiac cycles at end-expiration. The measurements will be performed offline, by two independent echocardiographers. Each of them will provide a mean for each measurement. The two means will be averaged for each criteria.
Measured: From enrollment to the end of the pre-operative trans-esophageal echo
Secondary outcomes (1)
Concordance between the grade of aortic regurgitation based on the pre-operative trans-thoracic echo and a trans-thoracic echo repeated immediately after induction of anesthesia.
The aortic regurgitation will be graded similarly as described for the primary outcome.
Measured: Enrollment to end of pre-operative trans-thoracic echo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start1 Mar 2025
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Regurgitation DiseaseStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06835946
- Sponsor's protocol ID
- ANESTIAO
- Status last verified
- Feb 2025
- First submitted
- 14 Feb 2025
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators did not consider this when they decided which legal basis would be claimed to collect the data in agreement with the rules of the European general data protection regulation.
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Single-center Observational Trial Aimed at Investigating the Effect of General Anesthesia, Positive Pressure Ventilation and Change of Imaging Modality From Transthoracic Echo to Transesophageal Echo on the Grading of the Severity of Aortic Regurgitation.
- ClinicalTrials.gov ID
- NCT06835946
- Acronym / sponsor ID
- ANESTIAO
- Conditions
- Aortic Regurgitation Disease, Aortic Insufficiency
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 19 Feb 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 goal of this observational study is to assess the impact of imaging modality (trans-thoracic echo (TTE) vs trans-esophageal echo (TEE)), anesthesia and positive pressure ventilation on the grading of aortic insufficiency.
Patients scheduled for cardiac surgery and in whom a TEE is going to be performed intra-operatively will be enrolled. The grading of the aortic insufficiency will be compared between a TTE performed immediately before the induction of general anesthesia end the TEE performed after induction of general anesthesia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients scheduled for cardiac surgery with previously known aortic regurgitation of any grade | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients scheduled for cardiac surgery at the "Centre Hospitalier Universitaire de Liège" with any grade of known preoperative aortic regurgitation.
Key inclusion criteria (2 listed)
- Known aortic regurgitation of any grade
- Scheduled for a cardiac surgery procedure during which a trans-esophageal echo is planned.
Key exclusion criteria (5 listed)
- Non sinus rhythm
- Mitral regurgitation more than mild.
- Pre-operative critical state (according to the definition of the EuroSCORE II)
- Presence of a prosthetic aortic valve
- Contra-indication to trans-esophageal echo
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
Concordance between the grade of aortic regurgitation on pre-operative TTE and intra-operative TEE
Time frame: From enrollment to the end of the pre-operative trans-esophageal echo
The preoperative TTE will be performed immediately before anesthesia induction. The intra-operative TEE will be performed after anesthesia induction. Five measurements will be used to grade the aortic regurgitation including three major (vena contracta, ration between the width of the aortic regurgitation and the left ventricular outflow tract, and the pressure half time) and two minor (diastolic flow reversal in descending aorta and effective regurgitation orifice area assessed by the proximal isovelocity surface area method). The images required to perform these measurements will be acquired three times on non contiguous cardiac cycles at end-expiration. The measurements will be performed offline, by two independent echocardiographers. Each of them will provide a mean for each measurement. The two means will be averaged for each criteria.
1 secondary outcome
Concordance between the grade of aortic regurgitation based on the pre-operative trans-thoracic echo and a trans-thoracic echo repeated immediately after induction of anesthesia.
Time frame: Enrollment to end of pre-operative trans-thoracic echo
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 10 Apr 2025.
- Individual participant dataSharing planned: No. The investigators did not consider this when they decided which legal basis would be claimed to collect the data in agreement with the rules of the European general data protection regulation.
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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 Aortic Regurgitation Disease and Aortic Insufficiency, run by University of Liege at 1 site in Belgium.
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 2 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 10 Apr 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 Belgium. 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 Alan Houven, MD (+3243237655, ahouben@chuliege.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concordance between the grade of aortic regurgitation on pre-operative TTE and intra-operative TEE (time frame: From enrollment to the end of the pre-operative trans-esophageal echo). 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 10 Apr 2025.