Mitral Valve InsufficiencyTENSCHORDNCT04709042
Acquisition of Objective Data During Transapical Neochordae Implantation
A study testing Chordal tension measurement and Cardiac Magnetic Resonance Imaging (MRI) in people with Mitral Valve Insufficiency and Mitral Regurgitation, run by Hospices Civils de Lyon.
Trial summary
Mitral Valve repair (MVr) is the gold standard treatment for primary Mitral Regurgitation. Implantation of artificial Gore-Tex chordae (or neochordae implantation) is often used for MVr. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Valve Insufficiency, Mitral Regurgitation
- What is being tested?
- Chordal tension measurement and Cardiac Magnetic Resonance Imaging (MRI)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2021to 1 May 2024
- 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
- Adults (≥ 18 years old)
- Patient candidate for NeoChord procedure after validation by the local Heart-Team
- severe symptomatic MR due to a posterior prolapses, involving mainly the P2 segment (with a variable extension on P1 or P3, but never involving the commissures or the anterior leaflet). Also, a LAI (leaflet to annulus index) >1,25 will be required.
- and considered as high-risk for conventional surgery (mainly because of frailty) after selection by our heart team.
- Patient who has provided his written informed consent to participate in the study
- Patient affiliated to a social health insurance.
Who cannot join
- Patient with contraindication for NeoChord technic including:
- Patient with secondary MR
- LV dilatation with initial tethering
- Central component to regurgitant jet
- Calcified leaflets segments.
- Patient with contraindication for Cardiovascular Magnetic Resonance (CMR) imaging:
Show all 13Show fewer
- Patients without sinus rhythm
- Regular MRI contraindications (e.g. a pacemaker, defibrillator or metallic (ferromagnetic) body, a known allergy to gadolinium)
- Contraindication for Gadolinium infusion : glomerular filtration rate (GFR) <30 ml / min
- Patient unable to understand the purpose of the study
- Patient participating in another trial that would interfere with this study
- Female patient who is pregnant or lactating
- Patients under judicial protection
About this study
Mitral Valve repair (MVr) is the gold standard treatment for primary Mitral Regurgitation. Implantation of artificial Gore-Tex chordae (or neochordae implantation) is often used for MVr.
The NeoChord DS1000 (NeoChord Inc., Minneapolis, USA) is a device designed to deploy neochordae through transapical access in a beating heart and without cardiopulmonary bypass. NeoChord System is CE marked and therefore authorized for use in Europe. Procedure is conducted under 3D transesophageal echocardiography (TEE) guidance. The device is introduced through the apex of the left ventricular (LV) and the prolapsed leaflet is grabbed and harpooned.
Read more
The neochordae are thus stretched between the valve and the LV apex. Neochordae length can be precisely adapted to restore a normal coaptation, to treat the regurgitation.
Recently, the principal investigator's teams (heart surgery department at Hospices Civils de Lyon and Laboratoire de Génie Electrique et Ferromagnétique lab at Institut National des Sciences Appliquées (INSA) de Lyon, France) created a platform allowing the measurement of the tension applied on neochordae during a NeoChord procedure. A dedicated protocol was designed and approved by the ethical committee of the French Society of Cardiology. The measurement was performed in 7 patients. This preliminary study shows that the technic is safe. It also suggests that chordal tension might be correlated to the quality of MVr: the sub-valvular apparatus appears to be in a low stress state when the structure and the function of the valve are restored.
These first findings raise new questions:
- The mechanism involved in the changes in tensions during chordal length adjustment cannot be understood with current standard medical imaging tools. Numerical simulation technologies could bring physical data in order to approach physical phenomenon underlying these findings.
- Novel chordal tension measurement tools could lead to a change in current paradigm enabling a MVr based on objective data measurement, instead of sole morphological analysis. Prognostic value of chordal tension must be studied through a larger clinical study and a systematic protocol.
A large consortium involving physicians and scientists has been created to address those questions, and a large national funding has been raised to fulfil our objectives over a 4 years period (SIMR project). The present clinical study is the core of this large project.
- Conditions
- Mitral Valve Insufficiency, Mitral Regurgitation
- Being tested
- Chordal tension measurement, Cardiac Magnetic Resonance Imaging (MRI)
- Keywords
- Primary Mitral Regurgitation, Mitral Valve repair, Heart Surgery, Neochord DS1000, Intraoperative Chordal Tension, Tension Measurement, Cardiac Magnetic Resonance Imaging, Postoperative echocardiographic evaluation
- Medical subject headings
- Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chordal tension measurementProcedure or surgery
The chordal tension measurement will be performed during surgery. The neochordae are connected to the measuring device through "crocodile" clips (e.g. machine-patient interface).We start to apply traction on the chordae that is in the center of the flailing area thanks to a millimeter screw and under TEE control. After obtaining a stable tension (plateau value), the other chordae are then tracked, one at a time, with an individual screw. When we achieve an equivalent tension on all chordae, a traction on all chordae is applied thanks to the principal screw under TEE control until obtaining a perfect coaptation. When the correction is optimal (good echocardiographic result, chordal tension low and equally spread on each chordae), the measurements are then stopped, and the chordae are fixed at the apex of the left ventricle at the optimal length.
Cardiac Magnetic Resonance Imaging (MRI)Other
Patients will undergo 2 MRI exams: 1 MRI before surgical intervention (maximum 21 days before) and 1 MRI three months after surgery (+/- 14 days), with intravenous administration of gadolinium.
| Study group | Role | What they receive |
|---|---|---|
| Chordal tension measurement and cardiac Magnetic Resonance Imaging | Experimental | All patient candidates for NeoChord implantation according to the standard of care will be considered for inclusion in this clinical study. Chordal tension measurement will be performed during Neochord implantation. Moreover, all patients will undergo cardiac Magnetic Resonance Imaging (MRI) exam before the surgery, as well as at 3 months follow-up. Receives: Procedure: Chordal tension measurement; Other: Cardiac Magnetic Resonance Imaging (MRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlate intraoperative chordal tension and postoperative echocardiographic mitral valve repair success (defined as mitral regurgitation (MR) ≤2+)
Correlation between intraoperative chordal tension (measured in mmHg) and postoperative echocardiographic mitral valve repair success (defined as mitral regurgitation (MR) ≤2+)
Measured: Day 0
Correlate intraoperative chordal tension and postoperative echocardiographic mitral valve repair success (defined as mitral regurgitation (MR) ≤2+)
Correlation between intraoperative chordal tension (measured in mmHg) and postoperative echocardiographic mitral valve repair success (defined as mitral regurgitation (MR) ≤2+)
Measured: 1 month after surgery
Correlate intraoperative chordal tension and postoperative echocardiographic mitral valve repair success (defined as mitral regurgitation (MR) ≤2+)
Correlation between intraoperative chordal tension (measured in mmHg) and postoperative echocardiographic mitral valve repair success (defined as mitral regurgitation (MR) ≤2+)
Measured: 12 months after surgery
Secondary outcomes (22)
Duration of procedure in minutes
Intraoperative safety is assessed by procedure duration in minutes (defined as skin incision to skin closure)
Measured: Day 0
Number of adverse events (AEs) and serious adverse events (SAEs)
Post-operative safety is assessed by occurrence of adverse events (AEs) and serious adverse events (SAEs) at each of the follow-up times
Measured: 12 months
Duration of hospitalization
Post-operative safety is assessed by duration of hospitalization
Measured: From the end of surgery (Day 0) to discharge from hospital (Day 15)
Number of patients with mitral regurgitation (MR) > 2+
Mitral regurgitation is assessed by echocardiographic exam
Measured: 1 month after surgery
Number of patients with mitral regurgitation (MR) > 2+
Mitral regurgitation is assessed by echocardiographic exam
Measured: 12 months after surgery
Number of rehospitalization for heart failure and mitral valve reoperation
Freedom from rehospitalization for heart failure and Mitral valve reoperation free survival
Measured: 1 month after surgery
Number of rehospitalization for heart failure and mitral valve reoperation
Freedom from rehospitalization for heart failure and Mitral valve reoperation free survival
Measured: 3 months after surgery
Number of rehospitalization for heart failure and mitral valve reoperation
Freedom from rehospitalization for heart failure and Mitral valve reoperation free survival
Measured: 12 months after surgery
New York Heart Association (NYHA) score
Change in functional evaluation is assessed by NYHA functional classification of heart failure. It is based on symptom severity and the amount of exertion needed to provoke symptoms. NYHA heart failure classes are as follows : Class I No limitation of physical activity, Class II Slight limitation of physical activity, in which ordinary physical activity leads to fatigue, palpitation, or dyspnea; the person is comfortable at rest, Class III Marked limitation of physical activity, in which less-than-ordinary activity results in fatigue, palpitation, or dyspnea; the person is comfortable at rest and Class IV Inability to carry on any physical activity without discomfort but also symptoms of heart failure at rest, with increased discomfort if any physical activity is undertaken.
Measured: Inclusion
New York Heart Association (NYHA) score
Change in functional evaluation is assessed by NYHA functional classification of heart failure. It is based on symptom severity and the amount of exertion needed to provoke symptoms. NYHA heart failure classes are as follows : Class I No limitation of physical activity, Class II Slight limitation of physical activity, in which ordinary physical activity leads to fatigue, palpitation, or dyspnea; the person is comfortable at rest, Class III Marked limitation of physical activity, in which less-than-ordinary activity results in fatigue, palpitation, or dyspnea; the person is comfortable at rest and Class IV Inability to carry on any physical activity without discomfort but also symptoms of heart failure at rest, with increased discomfort if any physical activity is undertaken.
Measured: Discharge from hospital (Day 15)
New York Heart Association (NYHA) score
Change in functional evaluation is assessed by NYHA functional classification of heart failure. It is based on symptom severity and the amount of exertion needed to provoke symptoms. NYHA heart failure classes are as follows : Class I No limitation of physical activity, Class II Slight limitation of physical activity, in which ordinary physical activity leads to fatigue, palpitation, or dyspnea; the person is comfortable at rest, Class III Marked limitation of physical activity, in which less-than-ordinary activity results in fatigue, palpitation, or dyspnea; the person is comfortable at rest and Class IV Inability to carry on any physical activity without discomfort but also symptoms of heart failure at rest, with increased discomfort if any physical activity is undertaken.
Measured: 1 month after surgery
New York Heart Association (NYHA) score
Change in functional evaluation is assessed by NYHA functional classification of heart failure. It is based on symptom severity and the amount of exertion needed to provoke symptoms. NYHA heart failure classes are as follows : Class I No limitation of physical activity, Class II Slight limitation of physical activity, in which ordinary physical activity leads to fatigue, palpitation, or dyspnea; the person is comfortable at rest, Class III Marked limitation of physical activity, in which less-than-ordinary activity results in fatigue, palpitation, or dyspnea; the person is comfortable at rest and Class IV Inability to carry on any physical activity without discomfort but also symptoms of heart failure at rest, with increased discomfort if any physical activity is undertaken.
Measured: 3 months after surgery
New York Heart Association (NYHA) score
Change in functional evaluation is assessed by NYHA functional classification of heart failure. It is based on symptom severity and the amount of exertion needed to provoke symptoms. NYHA heart failure classes are as follows : Class I No limitation of physical activity, Class II Slight limitation of physical activity, in which ordinary physical activity leads to fatigue, palpitation, or dyspnea; the person is comfortable at rest, Class III Marked limitation of physical activity, in which less-than-ordinary activity results in fatigue, palpitation, or dyspnea; the person is comfortable at rest and Class IV Inability to carry on any physical activity without discomfort but also symptoms of heart failure at rest, with increased discomfort if any physical activity is undertaken.
Measured: 12 months after surgery
The 3-level version of EQ-5D (EQ-5D-3L) health status score (quality of life score)
The EQ-5D-3L consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results into a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. The VAS can be used as a quantitative measure of health outcome that reflects the patient's own judgement.
Measured: Inclusion
The 3-level version of EQ-5D (EQ-5D-3L) health status score (quality of life score)
The EQ-5D-3L consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results into a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. The VAS can be used as a quantitative measure of health outcome that reflects the patient's own judgement.
Measured: Discharge from hospital (Day 15)
The 3-level version of EQ-5D (EQ-5D-3L) health status score (quality of life score)
The EQ-5D-3L consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results into a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. The VAS can be used as a quantitative measure of health outcome that reflects the patient's own judgement.
Measured: 1 month after surgery
The 3-level version of EQ-5D (EQ-5D-3L) health status score (quality of life score)
The EQ-5D-3L consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results into a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. The VAS can be used as a quantitative measure of health outcome that reflects the patient's own judgement.
Measured: 3 months after surgery
The 3-level version of EQ-5D (EQ-5D-3L) health status score (quality of life score)
The EQ-5D-3L consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results into a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. The VAS can be used as a quantitative measure of health outcome that reflects the patient's own judgement.
Measured: 12 months after surgery
Left ventricular volumes and function quantification
Left ventricular volumes and function quantification are assessed by Cardiac Magnetic Resonance Imaging (MRI)
Measured: Inclusion
Left ventricular volumes and function quantification
Left ventricular volumes and function quantification are assessed by Cardiac Magnetic Resonance Imaging (MRI)
Measured: 3 months after surgery
Number of left ventricular tissue fibrosis
Left ventricular tissue fibrosis are assessed by Cardiac Magnetic Resonance Imaging (MRI)
Measured: Inclusion
Number of left ventricular tissue fibrosis
Left ventricular tissue fibrosis are assessed by Cardiac Magnetic Resonance Imaging (MRI)
Measured: 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2021
- Study start1 May 2021 (estimated)
- Primary completion1 May 2024 (estimated)
- Study completion1 May 2024 (estimated)
Why it stopped: no more medical device implantation
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 Mitral Valve InsufficiencyStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel GRINBERG, MD, Principal investigator, Hôpital Pneumologique et Cardiovasculaire Louis Pradel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04709042
- Sponsor's protocol ID
- 69HCL19_1034
- Other IDs
- ID-RCB
- Acronym
- TENSCHORD
- Status last verified
- Mar 2022
- First submitted
- 11 Jan 2021
- Last updated
- 24 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Grinberg D, Cottinet PJ, Thivolet S, Audigier D, Capsal JF, Le MQ, Obadia JF. Measuring chordae tension during transapical neochordae implantation: Toward understanding objective consequences of mitral valve repair. J Thorac Cardiovasc Surg. 2019 Sep;158(3):746-755. doi: 10.1016/j.jtcvs.2018.10.029. Epub 2018 Oct 17.
PubMed 30454983
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acquisition of Objective Data During Transapical Neochordae Implantation
- ClinicalTrials.gov ID
- NCT04709042
- Acronym / sponsor ID
- TENSCHORD / 69HCL19_1034
- Conditions
- Mitral Valve Insufficiency, Mitral Regurgitation
- Keywords
- Primary Mitral Regurgitation, Mitral Valve repair, Heart Surgery, Neochord DS1000, Intraoperative Chordal Tension, Tension Measurement, Cardiac Magnetic Resonance Imaging, Postoperative echocardiographic evaluation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no more medical device implantation
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 May 2021 (estimated)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 14 Jan 2021 (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.
Mitral Valve repair (MVr) is the gold standard treatment for primary Mitral Regurgitation. Implantation of artificial Gore-Tex chordae (or neochordae implantation) is often used for MVr.
The NeoChord DS1000 (NeoChord Inc., Minneapolis, USA) is a device designed to deploy neochordae through transapical access in a beating heart and without cardiopulmonary bypass. NeoChord System is CE marked and therefore authorized for use in Europe. Procedure is conducted under 3D transesophageal echocardiography (TEE) guidance. The device is introduced through the apex of the left ventricular (LV) and the prolapsed leaflet is grabbed and harpooned.
The neochordae are thus stretched between the valve and the LV apex. Neochordae length can be precisely adapted to restore a normal coaptation, to treat the regurgitation.
Recently, the principal investigator's teams (heart surgery department at Hospices Civils de Lyon and Laboratoire de Génie Electrique et Ferromagnétique lab at Institut National des Sciences Appliquées (INSA) de Lyon, France) created a platform allowing the measurement of the tension applied on neochordae during a NeoChord procedure. A dedicated protocol was designed and approved by the ethical committee of the French Society of Cardiology. The measurement was performed in 7 patients. This preliminary study shows that the technic is safe. It also suggests that chordal tension might be correlated to the quality of MVr: the sub-valvular apparatus appears to be in a low stress state when the structure and the function of the valve are restored.
These first findings raise new questions:
- The mechanism involved in the changes in tensions during chordal length adjustment cannot be understood with current standard medical imaging tools. Numerical simulation technologies could bring physical data in order to approach physical phenomenon underlying these findings.
- Novel chordal tension measurement tools could lead to a change in current paradigm enabling a MVr based on objective data measurement, instead of sole morphological analysis. Prognostic value of chordal tension must be studied through a larger clinical study and a systematic protocol.
A large consortium involving physicians and scientists has been created to address those questions, and a large national funding has been raised to fulfil our objectives over a 4 years period (SIMR project). The present clinical study is the core of this large project.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chordal tension measurement and cardiac Magnetic Resonance Imaging | Experimental | Procedure: Chordal tension measurement, Other: Cardiac Magnetic Resonance Imaging (MRI)All patient candidates for NeoChord implantation according to the standard of care will be considered for inclusion in this clinical study. Chordal tension measurement will be performed during Neochord implantation. Moreover, all patients will undergo cardiac Magnetic Resonance Imaging (MRI) exam before the surgery, as well as at 3 months follow-up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults (≥ 18 years old)
- Patient candidate for NeoChord procedure after validation by the local Heart-Team
- Patient who has provided his written informed consent to participate in the study
- Patient affiliated to a social health insurance.
Key exclusion criteria (13 listed)
- Patient with contraindication for NeoChord technic including:
- Patient with contraindication for Cardiovascular Magnetic Resonance (CMR) imaging:
- Patient unable to understand the purpose of the study
- Patient participating in another trial that would interfere with this study
- Female patient who is pregnant or lactating
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 |
|---|---|---|
| Chordal tension measurementThe chordal tension measurement will be performed during surgery. The neochordae are connected to the measuring device through "crocodile" clips (e.g. machine-patient interface).We start to apply traction on the chordae that is in the center of the flailing area thanks to a millimeter screw and under TEE control. After obtaining a stable tension (plateau value), the other chordae are then tracked, one at a time, with an individual screw. When we achieve an equivalent tension on all chordae, a traction on all chordae is applied thanks to the principal screw under TEE control until obtaining a perfect coaptation. When the correction is optimal (good echocardiographic result, chordal tension low and equally spread on each chordae), the measurements are then stopped, and the chordae are fixed at the apex of the left ventricle at the optimal length. | Procedure or surgery | Chordal tension measurement and cardiac Magnetic Resonance Imaging |
| Cardiac Magnetic Resonance Imaging (MRI)Patients will undergo 2 MRI exams: 1 MRI before surgical intervention (maximum 21 days before) and 1 MRI three months after surgery (+/- 14 days), with intravenous administration of gadolinium. | Other | Chordal tension measurement and cardiac Magnetic Resonance Imaging |
Primary outcome
Correlate intraoperative chordal tension and postoperative echocardiographic mitral valve repair success (defined as mitral regurgitation (MR) ≤2+)
Time frame: Day 0
Correlation between intraoperative chordal tension (measured in mmHg) and postoperative echocardiographic mitral valve repair success (defined as mitral regurgitation (MR) ≤2+)
Correlate intraoperative chordal tension and postoperative echocardiographic mitral valve repair success (defined as mitral regurgitation (MR) ≤2+)
Time frame: 1 month after surgery
Correlation between intraoperative chordal tension (measured in mmHg) and postoperative echocardiographic mitral valve repair success (defined as mitral regurgitation (MR) ≤2+)
Correlate intraoperative chordal tension and postoperative echocardiographic mitral valve repair success (defined as mitral regurgitation (MR) ≤2+)
Time frame: 12 months after surgery
Correlation between intraoperative chordal tension (measured in mmHg) and postoperative echocardiographic mitral valve repair success (defined as mitral regurgitation (MR) ≤2+)
22 secondary outcomes
Duration of procedure in minutes
Time frame: Day 0
Number of adverse events (AEs) and serious adverse events (SAEs)
Time frame: 12 months
Duration of hospitalization
Time frame: From the end of surgery (Day 0) to discharge from hospital (Day 15)
Number of patients with mitral regurgitation (MR) > 2+
Time frame: 1 month after surgery
Number of patients with mitral regurgitation (MR) > 2+
Time frame: 12 months after surgery
Number of rehospitalization for heart failure and mitral valve reoperation
Time frame: 1 month after surgery
Number of rehospitalization for heart failure and mitral valve reoperation
Time frame: 3 months after surgery
Number of rehospitalization for heart failure and mitral valve reoperation
Time frame: 12 months after surgery
New York Heart Association (NYHA) score
Time frame: Inclusion
New York Heart Association (NYHA) score
Time frame: Discharge from hospital (Day 15)
New York Heart Association (NYHA) score
Time frame: 1 month after surgery
New York Heart Association (NYHA) score
Time frame: 3 months after surgery
New York Heart Association (NYHA) score
Time frame: 12 months after surgery
The 3-level version of EQ-5D (EQ-5D-3L) health status score (quality of life score)
Time frame: Inclusion
The 3-level version of EQ-5D (EQ-5D-3L) health status score (quality of life score)
Time frame: Discharge from hospital (Day 15)
The 3-level version of EQ-5D (EQ-5D-3L) health status score (quality of life score)
Time frame: 1 month after surgery
The 3-level version of EQ-5D (EQ-5D-3L) health status score (quality of life score)
Time frame: 3 months after surgery
The 3-level version of EQ-5D (EQ-5D-3L) health status score (quality of life score)
Time frame: 12 months after surgery
Left ventricular volumes and function quantification
Time frame: Inclusion
Left ventricular volumes and function quantification
Time frame: 3 months after surgery
Number of left ventricular tissue fibrosis
Time frame: Inclusion
Number of left ventricular tissue fibrosis
Time frame: 3 months after surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2022.
- Results publication: PubMed 30454983Grinberg D, Cottinet PJ, Thivolet S, Audigier D, Capsal JF, Le MQ, Obadia JF. Measuring chordae tension during transapical neochordae implantation: Toward understanding objective consequences of mitral valve repair. J Thorac Cardiovasc Surg. 2019 Sep;158(3):746-755. doi: 10.1016/j.jtcvs.2018.10.029. Epub 2018 Oct 17.
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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. This study is not recruiting at the moment.
Daniel GRINBERG, MD principal investigator
Hôpital Pneumologique et Cardiovasculaire Louis Pradel
Questions about this trial
What is this clinical trial studying?
A study testing Chordal tension measurement and Cardiac Magnetic Resonance Imaging (MRI) in people with Mitral Valve Insufficiency and Mitral Regurgitation, run by Hospices Civils de Lyon.
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 13 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: withdrawn, as of the sponsor's last update on 24 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Correlate intraoperative chordal tension and postoperative echocardiographic mitral valve repair success (defined as mitral regurgitation (MR) ≤2+) (time frame: Day 0). 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?
On the ClinicalTrials.gov record for NCT04709042, 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 24 Mar 2022.