Right VentricleRVLSBONCT05404737
Interchangeability of Right Ventricle Longitudinal Shortening in Echocardiography
A study testing transthoracic echocardiography (TTE) and transoesophageal echocardiography (TEE). in people with Right Ventricle and Speckle Tracking, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
RV longitudinal shortening fraction (RV-SLF) is based on the analysis of the tricuspid annulus displacement (TAD) and can be performed in transthoracic (TTE) or transoesophageal echocardiography (TEE). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Right Ventricle, Speckle Tracking, Strains
- What is being tested?
- transthoracic echocardiography (TTE) and transoesophageal echocardiography (TEE).
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- 31 May 2022to 1 Jan 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patient (>18 years)
- Patient hospitalized at the Amiens University Hospital for scheduled cardiac surgery under cardiopulmonary bypass.
- Information of the patient and collection of his non-opposition
Who cannot join
- Patient with a contraindication to the realization of TEE (gastric or mediastinal pathology)
- Patient with poor echogenicity on TEE not allowing evaluation of 2D-STE parameters of the right ventricle
- Patient with a rapid supraventricular rhythm disorder (HR > 100) at the time of TTE and/or TEE.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interchangeability of Right Ventricle Longitudinal Shortening Fraction Measurements Performed by Trans-thoracic and Trans-esophageal Echocardiography in the Operating Room
RV longitudinal shortening fraction (RV-SLF) is based on the analysis of the tricuspid annulus displacement (TAD) and can be performed in transthoracic (TTE) or transoesophageal echocardiography (TEE). Having an 2D-STE interchangeable parameter would allow accurate measurement of RV systolic function before, during and after cardiac surgery. However, to date, there are no data on the interchangeability of RV-LSF measurements performed in TTE and TEE.
The aim of the study is to evaluate the interchangeability of TTE and TEE measurements of RV-LSF during cardiopulmonary bypass surgery.
- Conditions
- Right Ventricle, Speckle Tracking, Strains, Cardiac Surgery
- Being tested
- transthoracic echocardiography (TTE), transoesophageal echocardiography (TEE).
- Keywords
- Right ventricle, speckle tracking, Strains, cardiac surgery
- Medical subject headings
- Sprains and Strains
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transthoracic echocardiography (TTE)Other
In order to evaluate the interchangeability of RV-LSF, a TTE will be performed just after the placement of general anesthesia, when the patient is under mechanical ventilation
transoesophageal echocardiography (TEE).Other
During cardiopulmonary bypass surgery patients is monitored by a TEE as recommended.
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of the RV-LSF (in %) between TTE and TEE
RV-LSF is : Right ventricular longitudinal shortening fraction. RV-LSF is an angle-independent and automatically calculated speckle-tracking parameter and reproducible parameter.
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2022
- Study start31 May 2022
- Primary completion1 Jan 2023
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Right VentricleStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05404737
- Sponsor's protocol ID
- PI2021_843_0056
- Acronym
- RVLSBO
- Status last verified
- Sep 2025
- First submitted
- 31 May 2022
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Beyls C, Huette P, Vangreveninge P, Leviel F, Daumin C, Ammar B, Touati G, Roger B, Caus T, Dupont H, Abou-Arab O, Momar D, Mahjoub Y. Interchangeability of right ventricular longitudinal shortening fraction assessed by transthoracic and transoesophageal echocardiography in the perioperative setting: A prospective study. Front Cardiovasc Med. 2022 Dec 23;9:1074956. doi: 10.3389/fcvm.2022.1074956. eCollection 2022.
PubMed 36620637
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interchangeability of Right Ventricle Longitudinal Shortening Fraction Measurements Performed by Trans-thoracic and Trans-esophageal Echocardiography in the Operating Room
- ClinicalTrials.gov ID
- NCT05404737
- Acronym / sponsor ID
- RVLSBO / PI2021_843_0056
- Conditions
- Right Ventricle, Speckle Tracking, Strains, Cardiac Surgery
- Keywords
- Right ventricle, speckle tracking, Strains, cardiac surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 31 May 2022 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 3 Jun 2022 (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.
RV longitudinal shortening fraction (RV-SLF) is based on the analysis of the tricuspid annulus displacement (TAD) and can be performed in transthoracic (TTE) or transoesophageal echocardiography (TEE). Having an 2D-STE interchangeable parameter would allow accurate measurement of RV systolic function before, during and after cardiac surgery. However, to date, there are no data on the interchangeability of RV-LSF measurements performed in TTE and TEE.
The aim of the study is to evaluate the interchangeability of TTE and TEE measurements of RV-LSF during cardiopulmonary bypass surgery.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patient (>18 years)
- Patient hospitalized at the Amiens University Hospital for scheduled cardiac surgery under cardiopulmonary bypass.
- Information of the patient and collection of his non-opposition
Key exclusion criteria (3 listed)
- Patient with a contraindication to the realization of TEE (gastric or mediastinal pathology)
- Patient with poor echogenicity on TEE not allowing evaluation of 2D-STE parameters of the right ventricle
- Patient with a rapid supraventricular rhythm disorder (HR > 100) at the time of TTE and/or TEE.
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 |
|---|---|---|
| transthoracic echocardiography (TTE)In order to evaluate the interchangeability of RV-LSF, a TTE will be performed just after the placement of general anesthesia, when the patient is under mechanical ventilation | Other | – |
| transoesophageal echocardiography (TEE).During cardiopulmonary bypass surgery patients is monitored by a TEE as recommended. | Other | – |
Primary outcome
Variation of the RV-LSF (in %) between TTE and TEE
Time frame: one day
RV-LSF is : Right ventricular longitudinal shortening fraction. RV-LSF is an angle-independent and automatically calculated speckle-tracking parameter and reproducible parameter.
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 19 Sep 2025.
- Results publication: PubMed 36620637Beyls C, Huette P, Vangreveninge P, Leviel F, Daumin C, Ammar B, Touati G, Roger B, Caus T, Dupont H, Abou-Arab O, Momar D, Mahjoub Y. Interchangeability of right ventricular longitudinal shortening fraction assessed by transthoracic and transoesophageal echocardiography in the perioperative setting: A prospective study. Front Cardiovasc Med. 2022 Dec 23;9:1074956. doi: 10.3389/fcvm.2022.1074956. eCollection 2022.
- Individual participant dataSharing planned: No
Related trials for Right Ventricle
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LEVOSIMENDAN, PULMONARY THROMBOENDARTERECTOMY
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?
A study testing transthoracic echocardiography (TTE) and transoesophageal echocardiography (TEE). in people with Right Ventricle and Speckle Tracking, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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 3 inclusion and 3 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 19 Sep 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 France. 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?
Variation of the RV-LSF (in %) between TTE and TEE (time frame: one day). 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 NCT05404737, which also lists 1 linked publication.
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 19 Sep 2025.