Aortic Valve DisorderNCT03298932
2D Strain of Right Ventricle in Peroperative of Cardiac Surgery
An observational study of Aortic Valve Disorder, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Evaluation of the right ventricle (RV) deformation (strain) with 2D speckle tracking technics obtained by echocardiographies (TEE) in peroperative period of cardiac surgery . TEE is performed for each patient of cardiac surgery during the operation time . Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Aortic Valve Disorder
- What is being tested?
- Aortic valve surgery
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 19 Sep 2016to 7 Jun 2017
- Phase
- Observational
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient eligible for aortic valve surgery
Who may be able to join
- patient eligible for aortic valve surgery
Who cannot join
- previous right ventricle dysfunction
- severe coronary disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 2D Strain of Right Ventricle in Peroperative Cardiac Surgery : Evaluation of Early Signs of RV Dysfunction
Evaluation of the right ventricle (RV) deformation (strain) with 2D speckle tracking technics obtained by echocardiographies (TEE) in peroperative period of cardiac surgery .
TEE is performed for each patient of cardiac surgery during the operation time .
This new evaluation parameter of RV could be a good tool to assess the early RV dysfunction after cardiac surgery.
Read the detailed description
Monitoring of 2D strain of right ventricle free wall by TEE in perioperative of cardiac surgery :
In preoperative time After sternotomy After surgery Inclusions of patients elected for aortic valve surgery without coronary diseases or previous RV dysfunction.
Comparison with others echocardiographic parameters of RV evaluation Association with right ventricle insufficiency after cardiac surgery.
- Conditions
- Aortic Valve Disorder
- Being tested
- Aortic valve surgery
- Keywords
- Transesophageal echography, Perioperative cardiac surgery, Aortic valve replacement, 2D strain of right ventricle
- Medical subject headings
- Aortic Valve Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aortic valve surgeryProcedure or surgery
Aortic valve surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
2D strain modification of right ventricle after cardiac surgery
Measured: up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2017
- Study start19 Sep 2016
- Primary completion1 Jan 2017
- Study completion7 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Géraldine CULAS, MD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03298932
- Sponsor's protocol ID
- 9597
- Status last verified
- Oct 2016
- First submitted
- 11 Oct 2016
- Last updated
- 29 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 2D Strain of Right Ventricle in Peroperative Cardiac Surgery : Evaluation of Early Signs of RV Dysfunction
- ClinicalTrials.gov ID
- NCT03298932
- Acronym / sponsor ID
- 9597
- Conditions
- Aortic Valve Disorder
- Keywords
- Transesophageal echography, Perioperative cardiac surgery, Aortic valve replacement, 2D strain of right ventricle
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 19 Sep 2016 (actual)
- Primary completion
- 1 Jan 2017 (actual)
- Study completion
- 7 Jun 2017 (actual)
- First posted
- 2 Oct 2017 (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.
Evaluation of the right ventricle (RV) deformation (strain) with 2D speckle tracking technics obtained by echocardiographies (TEE) in peroperative period of cardiac surgery .
TEE is performed for each patient of cardiac surgery during the operation time .
This new evaluation parameter of RV could be a good tool to assess the early RV dysfunction after cardiac surgery.
Detailed description
Monitoring of 2D strain of right ventricle free wall by TEE in perioperative of cardiac surgery :
In preoperative time After sternotomy After surgery Inclusions of patients elected for aortic valve surgery without coronary diseases or previous RV dysfunction.
Comparison with others echocardiographic parameters of RV evaluation Association with right ventricle insufficiency after cardiac surgery.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient eligible for aortic valve surgery
Key inclusion criteria (1 listed)
- patient eligible for aortic valve surgery
Key exclusion criteria (2 listed)
- previous right ventricle dysfunction
- severe coronary disease
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 |
|---|---|---|
| Aortic valve surgeryAortic valve surgery | Procedure or surgery | – |
Primary outcome
2D strain modification of right ventricle after cardiac surgery
Time frame: up to 24 hours
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 29 Mar 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Aortic Valve Disorder
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Active, not recruitingObservational study
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
Iliac Disease, Aortic Valve Stenosis
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic
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.
Géraldine CULAS, MD principal investigator
University Hospital, Montpellier
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 Valve Disorder, run by University Hospital, Montpellier 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 1 inclusion and 2 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 29 Mar 2018. 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?
2D strain modification of right ventricle after cardiac surgery (time frame: up to 24 hours). 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 29 Mar 2018.