Severe Mitral Valve Regurgitation (Disorder)TEERMISONCT05090540
Transcatheter Versus Standard Surgical Mitral Valve Operation for Secondary Mitral Regurgitation
An observational study of Severe Mitral Valve Regurgitation (Disorder), run by Centre Cardiologique du Nord at 2 sites in France.
Trial summary
The mechanical intervention is treating secondary mitral regurgitation (SMR) which may be performed using the standard open surgical approach or transcatheter edge to edge repair (TEER). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Severe Mitral Valve Regurgitation (Disorder)
- What is being tested?
- Trancatheter Edge to Edge Repair, Mitral Valve Replacement and Restrictive Mitral Annuloplastie
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 600 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Jun 2017to 30 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with severe secondary mitral regurgitation with or without multivessel coronary artery disease who were symptomatic for congestive heart failure and unresponsive to medical therapy were eligible for surgical repair or replacement combined or not to coronary artery bypass graft (CABG). The severity of SMR was evaluated by transthoracic echocardiography, which was performed using European Society of Echocardiography criteria. Severe MR was defined as an effective regurgitant orifice area (EROA) of at least 0.4 cm2 or by a combination of adjunctive echocardiographic quantification methods according to guidelines. MR grade was defined according to EROA.
Who may be able to join
- Adult
- Ischemic NoIschemic cardiomyopathy
- EROA> 0,2 cm2 or Regurgitant Volume > 30 ml (ESC guidelines).
- EROA ≥ 0.4 cm2 with tethering (ACC/AHA)
- MR Grade 3/4
- Eligible for TEE, surgical repair and replacement of mitral valve
- Coronary artery disease with or without the need for coronary revascularization
- Average value LVEDD 62 mm LVEF 42%
Who cannot join
- Pediatric
- Any echocardiographic evidence of structural (chordal or leaflet) mitral-valve disease
- ruptured papillary
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites
Francesco Nappi
Saint-Denis, 93200
Centre Cardiologique Du Nord
Saint-Denis
About this study
Official title: Transcatheter Edge to Edge Mitral Valve Repair Versus Standard Surgical Mitral Valve Operation for Secondadry Mitral Regurgitation
The mechanical intervention is treating secondary mitral regurgitation (SMR) which may be performed using the standard open surgical approach or transcatheter edge to edge repair (TEER). The key question of this study is to establish the difference in left ventricular reverse remodeling after adjustment for death, as assessed by means of the left ventricular end-systolic dimension(LVESD), all-cause and cause-specific (cardiac vs noncardiac) mortality in patients who received the TEER vs the standard surgical procedure for SMR.
Read the detailed description
The target population enrolled in the registry includes patients with moderate to severe secondary mitral regurgitation due to cardiomyopathy of either ischemic or non-ischemic etiology who have had TEER or standard surgical procedure of their mitral valves with or without CABG. Individuals were adequately treated per applicable standards, including for coronary artery disease, LV dysfunction, mitral regurgitation, and heart failure. Patients enrolled in the studies were NYHA functional class II, III, or outpatient NYHA IV.
Four groups of patients are included in the study. Patients who were managed with TEER, patients who received mitral valve replacement and recipients of mitral valve repair who underwent surgery with the use of restrictive annuloplasty alone or combined with subvalvular repair. Four groups of patients are included in the study. Patients who were managed with TEER, patients who received mitral valve replacement, and those who received mitral valve repair who underwent surgery with the use of restrictive annuloplasty alone or combined with subvalvular repair
- Being tested
- Trancatheter Edge to Edge Repair, Mitral Valve Replacement, Restrictive Mitral Annuloplastie, Restrictive Mitral Annuloplastie/Subvalvular Repair
- Keywords
- SMR; TEER; MVRpl; MVR; RMA; Subvalvular Repair
- 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.
Trancatheter Edge to Edge RepairDevice
Also called Mitraclip procedure
TEER is performed by apposing the edges of the anterior and posterior leaflet (edge-to-edge) of prolapsed MV. The patient may be under conscious sedation or general anesthesia, depending on hospital standard practice. The procedure is performed through femoral venous access and the inter-atrial septum is crossed using standard techniques. Trans-septal puncture allows MitraClip Steerable Guide Catheter (Guide) to advance so that the guide is positioned over the mitral valve. The MitraClip delivery catheter is advanced to the MitraClip device and emerges from the tip of the guide into the left atrium. The MitraClip device can now be opened and advanced through the MV in the LV. Once in the LV, it is pulled back to grasp the leaflets. Two-dimensional and/or 3-dimensional echocardiography and color Doppler are useful for evaluating the anatomical features of the mitral valve and directing the procedure until the double orifice is formed alongside evaluating residual mitral regurgitation
Mitral Valve ReplacementProcedure or surgery
Mitral valve replacement is performed using mechanical or biological prosthesis while preserving the subvalvular apparatus to avoid dilation of the left ventricle over time.
Restrictive Mitral AnnuloplastieProcedure or surgery
Also called Undersizing Mitral Annuloplastie
Mitral valve repair consists of a restrictive mitral annuloplasty (RMA) using a prosthetic ring
Restrictive Mitral Annuloplastie/Subvalvular RepairProcedure or surgery
RMA may be associated with the use of a subvalvular repair (SR). The SR permits the approximation or the relocation of papillary muscles which is displaced by post infarction scar formation.
| Study group | Role | What they receive |
|---|---|---|
| Transcatheter Edge to Edge Repair | TEER procedure is performed by apposing the edges of the anterior and posterior leaflet (edge-to-edge) of MV. If the use of one MitraClip device does not result in sufficient reduction in mitral regurgitation, a second MitraClip device may be used to reduce MR optimizing the procedure. Receives: Device: Trancatheter Edge to Edge Repair | |
| Mitral Valve Replacement | Mitral-valve replacement includes complete preservation of the subvalvular apparatus to avoid dilation of the left ventricle over time. The technique of preservation, type of prosthetic valve implanted, and technique of suture placement has been chosen according to the preference of the surgeons. In SMR due to ischemic cardiomyopathy, CABG operation(Revascularization) is required Receives: Procedure: Mitral Valve Replacement | |
| Restrictive Mitral Annuloplasty | RMA may be performed with the use of complete rigid or semi-rigid annuloplasty ring which has been downsized for the annulus diameter. Since patients who received RMA have coronary artery lesions, a CABG operation is useful to ensure favorable remodeling of the left ventricle. Receives: Procedure: Restrictive Mitral Annuloplastie | |
| Restrictive Mitral Annuloplastie Plus Subvalvular Repair | RMA may be associated with the use of a subvalvular repair (SVR). The SVR permits the approximation or the relocation of papillary muscles which is displaced by post infarction scar formation. In patients who received SVR due to ischemic cardiomyopathy CABG operation is required Receives: Procedure: Restrictive Mitral Annuloplastie/Subvalvular Repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left Ventricular Reverse Remodelling
The primary end point of the study is the degree of left ventricular reverse remodeling, as assessed by means of the left ventricular end systolic dimension on the basis of transthoracic echocardiography
Measured: 5 years
Secondary outcomes (10)
Overall Mortality
The secondary endpoint of the study is the evaluation of overall mortality
Measured: 5 years
Cardiac Death
The secondary endpoint of the study is the evaluation of cardiac death
Measured: 5 years
Major Adverse Cardiac or Cerebrovascular Events (MACCE)
Composite of major adverse cardiac or cerebrovascular events (rate of death, stroke, subsequent mitral valve surgery, hospitalization for heart failure, or an increase in New York Heart Association class higher than one), serious adverse events, recurrent mitral regurgitation, quality of life, and rehospitalization.
Measured: 5 years
Echocardiographic Parameter Changes (LVEF)
Changes from baseline parameters including left ventricular ejection fraction
Measured: 5 years
Echocardiographic Parameter Changes (recurrence)
Recurrent moderate-to-severe mitral regurgitation after intervention
Measured: 5 years
Echocardiographic Parameter Changes (LVEDD)
Changes from baseline Left Ventricular End Diastolic Diameter
Measured: 5 years
Echocardiographic Parameter Changes (Mitral Valve tenting area and height)
Changes from baseline tenting area and height
Measured: 5 years
Echocardiographic Parameter Changes (Pulmonary artery systolic pressure)
Changes from baseline pulmonary artery systolic pressure
Measured: 5 years
Echocardiographic Parameter Changes (anteroposterior mitral valve annular diameter)
Changes from baseline anteroposterior mitral valve annular diameter
Measured: 5 years
Echocardiographic Parameter Changes ( interpapillary distance)
Changes from baseline distance between papillary muscles
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2021
- Study start1 Jun 2017
- Primary completion1 Mar 2024
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Severe Mitral Valve Regurgitation (Disorder)Studies 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
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Cardiologique du Nord
- Sponsor type
- University, hospital or other
- Collaborators
- Campus Bio-Medico University, Henri Mondor University Hospital, Hokkaido University, University of Genova
- Responsible party
- Principal investigator, Francesco Nappi, Centre Cardiologique du Nord
- Investigators
- Francesco Nappi, MD, Principal investigator, Centre Cardiologique du Nord
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05090540
- Sponsor's protocol ID
- CN-21-23
- Other IDs
- CN-21-23
- Acronym
- TEERMISO
- Status last verified
- May 2026
- First submitted
- 23 Sep 2021
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nappi F, Singh SSA, Salsano A, Spadaccio C, Shingu Y, Wakasa S, Fiore A. Study protocol for an international registry observational study evaluating clinical outcomes of transcatheter versus standard surgical mitral valve operation for secondary mitral regurgitation: the TEERMISO study. BMJ Open. 2025 Jan 8;15(1):e086888. doi: 10.1136/bmjopen-2024-086888.
PubMed 39779262Nappi F, Avtaar Singh SS, Salsano A, Nassif A, Shingu Y, Wakasa S, Fiore A, Spadaccio C, El-Dean Z. A Protocol Investigation Comparing Transcatheter Repair with the Standard Surgical Procedure for Secondary Mitral Regurgitation. J Clin Med. 2024 Dec 18;13(24):7742. doi: 10.3390/jcm13247742.
PubMed 39768667
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcatheter Edge to Edge Mitral Valve Repair Versus Standard Surgical Mitral Valve Operation for Secondadry Mitral Regurgitation
- ClinicalTrials.gov ID
- NCT05090540
- Acronym / sponsor ID
- TEERMISO / CN-21-23
- Keywords
- SMR; TEER; MVRpl; MVR; RMA; Subvalvular Repair
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Centre Cardiologique du NordUniversity, hospital or other
- Collaborators
- Campus Bio-Medico University, Henri Mondor University Hospital, Hokkaido University, University of Genova
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 22 Oct 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.
The mechanical intervention is treating secondary mitral regurgitation (SMR) which may be performed using the standard open surgical approach or transcatheter edge to edge repair (TEER). The key question of this study is to establish the difference in left ventricular reverse remodeling after adjustment for death, as assessed by means of the left ventricular end-systolic dimension(LVESD), all-cause and cause-specific (cardiac vs noncardiac) mortality in patients who received the TEER vs the standard surgical procedure for SMR.
Detailed description
The target population enrolled in the registry includes patients with moderate to severe secondary mitral regurgitation due to cardiomyopathy of either ischemic or non-ischemic etiology who have had TEER or standard surgical procedure of their mitral valves with or without CABG. Individuals were adequately treated per applicable standards, including for coronary artery disease, LV dysfunction, mitral regurgitation, and heart failure. Patients enrolled in the studies were NYHA functional class II, III, or outpatient NYHA IV.
Four groups of patients are included in the study. Patients who were managed with TEER, patients who received mitral valve replacement and recipients of mitral valve repair who underwent surgery with the use of restrictive annuloplasty alone or combined with subvalvular repair. Four groups of patients are included in the study. Patients who were managed with TEER, patients who received mitral valve replacement, and those who received mitral valve repair who underwent surgery with the use of restrictive annuloplasty alone or combined with subvalvular repair
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Transcatheter Edge to Edge Repair | – | Device: Trancatheter Edge to Edge RepairTEER procedure is performed by apposing the edges of the anterior and posterior leaflet (edge-to-edge) of MV. If the use of one MitraClip device does not result in sufficient reduction in mitral regurgitation, a second MitraClip device may be used to reduce MR optimizing the procedure. |
| Mitral Valve Replacement | – | Procedure: Mitral Valve ReplacementMitral-valve replacement includes complete preservation of the subvalvular apparatus to avoid dilation of the left ventricle over time. The technique of preservation, type of prosthetic valve implanted, and technique of suture placement has been chosen according to the preference of the surgeons. In SMR due to ischemic cardiomyopathy, CABG operation(Revascularization) is required |
| Restrictive Mitral Annuloplasty | – | Procedure: Restrictive Mitral AnnuloplastieRMA may be performed with the use of complete rigid or semi-rigid annuloplasty ring which has been downsized for the annulus diameter. Since patients who received RMA have coronary artery lesions, a CABG operation is useful to ensure favorable remodeling of the left ventricle. |
| Restrictive Mitral Annuloplastie Plus Subvalvular Repair | – | Procedure: Restrictive Mitral Annuloplastie/Subvalvular RepairRMA may be associated with the use of a subvalvular repair (SVR). The SVR permits the approximation or the relocation of papillary muscles which is displaced by post infarction scar formation. In patients who received SVR due to ischemic cardiomyopathy CABG operation is required |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with severe secondary mitral regurgitation with or without multivessel coronary artery disease who were symptomatic for congestive heart failure and unresponsive to medical therapy were eligible for surgical repair or replacement combined or not to coronary artery bypass graft (CABG). The severity of SMR was evaluated by transthoracic echocardiography, which was performed using European Society of Echocardiography criteria. Severe MR was defined as an effective regurgitant orifice area (EROA) of at least 0.4 cm2 or by a combination of adjunctive echocardiographic quantification methods according to guidelines. MR grade was defined according to EROA.
Key inclusion criteria (8 listed)
- Adult
- Ischemic NoIschemic cardiomyopathy
- EROA> 0,2 cm2 or Regurgitant Volume > 30 ml (ESC guidelines).
- EROA ≥ 0.4 cm2 with tethering (ACC/AHA)
- MR Grade 3/4
Key exclusion criteria (3 listed)
- Pediatric
- Any echocardiographic evidence of structural (chordal or leaflet) mitral-valve disease
- ruptured papillary
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 |
|---|---|---|
| Trancatheter Edge to Edge RepairAlso: Mitraclip procedureTEER is performed by apposing the edges of the anterior and posterior leaflet (edge-to-edge) of prolapsed MV. The patient may be under conscious sedation or general anesthesia, depending on hospital standard practice. The procedure is performed through femoral venous access and the inter-atrial septum is crossed using standard techniques. Trans-septal puncture allows MitraClip Steerable Guide Catheter (Guide) to advance so that the guide is positioned over the mitral valve. The MitraClip delivery catheter is advanced to the MitraClip device and emerges from the tip of the guide into the left atrium. The MitraClip device can now be opened and advanced through the MV in the LV. Once in the LV, it is pulled back to grasp the leaflets. Two-dimensional and/or 3-dimensional echocardiography and color Doppler are useful for evaluating the anatomical features of the mitral valve and directing the procedure until the double orifice is formed alongside evaluating residual mitral regurgitation | Device | Transcatheter Edge to Edge Repair |
| Mitral Valve ReplacementMitral valve replacement is performed using mechanical or biological prosthesis while preserving the subvalvular apparatus to avoid dilation of the left ventricle over time. | Procedure or surgery | Mitral Valve Replacement |
| Restrictive Mitral AnnuloplastieAlso: Undersizing Mitral AnnuloplastieMitral valve repair consists of a restrictive mitral annuloplasty (RMA) using a prosthetic ring | Procedure or surgery | Restrictive Mitral Annuloplasty |
| Restrictive Mitral Annuloplastie/Subvalvular RepairRMA may be associated with the use of a subvalvular repair (SR). The SR permits the approximation or the relocation of papillary muscles which is displaced by post infarction scar formation. | Procedure or surgery | Restrictive Mitral Annuloplastie Plus Subvalvular Repair |
Primary outcome
Left Ventricular Reverse Remodelling
Time frame: 5 years
The primary end point of the study is the degree of left ventricular reverse remodeling, as assessed by means of the left ventricular end systolic dimension on the basis of transthoracic echocardiography
10 secondary outcomes
Overall Mortality
Time frame: 5 years
Cardiac Death
Time frame: 5 years
Major Adverse Cardiac or Cerebrovascular Events (MACCE)
Time frame: 5 years
Echocardiographic Parameter Changes (LVEF)
Time frame: 5 years
Echocardiographic Parameter Changes (recurrence)
Time frame: 5 years
Echocardiographic Parameter Changes (LVEDD)
Time frame: 5 years
Echocardiographic Parameter Changes (Mitral Valve tenting area and height)
Time frame: 5 years
Echocardiographic Parameter Changes (Pulmonary artery systolic pressure)
Time frame: 5 years
Echocardiographic Parameter Changes (anteroposterior mitral valve annular diameter)
Time frame: 5 years
Echocardiographic Parameter Changes ( interpapillary distance)
Time frame: 5 years
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 19 May 2026.
- Derived from this study: PubMed 39779262Nappi F, Singh SSA, Salsano A, Spadaccio C, Shingu Y, Wakasa S, Fiore A. Study protocol for an international registry observational study evaluating clinical outcomes of transcatheter versus standard surgical mitral valve operation for secondary mitral regurgitation: the TEERMISO study. BMJ Open. 2025 Jan 8;15(1):e086888. doi: 10.1136/bmjopen-2024-086888.
- Derived from this study: PubMed 39768667Nappi F, Avtaar Singh SS, Salsano A, Nassif A, Shingu Y, Wakasa S, Fiore A, Spadaccio C, El-Dean Z. A Protocol Investigation Comparing Transcatheter Repair with the Standard Surgical Procedure for Secondary Mitral Regurgitation. J Clin Med. 2024 Dec 18;13(24):7742. doi: 10.3390/jcm13247742.
- Individual participant dataSharing planned: No
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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.
Francesco Nappi, MD principal investigator
Centre Cardiologique du Nord
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Mitral Valve Regurgitation (Disorder), run by Centre Cardiologique du Nord at 2 sites 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 8 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: enrolling by invitation, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
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?
Left Ventricular Reverse Remodelling (time frame: 5 years). 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 NCT05090540, which also lists 2 linked publications.
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 May 2026.