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Mitral Valve DiseaseMITRAGISTERNCT02925819

Management and Clinical Outcomes of Patients With Severe Mitral Valve Disease Not Suitable for Surgery

An observational study of Mitral Valve Disease, run by French Cardiology Society at 3 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The objective of this study is to collect in a prospective registry all cases of French patients undergoing an assessment for percutaneous treatment of mitral valve disease on a native valve or due to deterioration after surgical valve repair or replacement. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Mitral Valve Disease
How many people
500 participants
Where
3 sitesFrance
Study dates
Oct 2016to Dec 2026
How long will I take part?
2 Years
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: French patients undergoing an assessment for percutaneous treatment of symptomatic severe mitral valve disease on a native valve or due to deterioration after surgical valve repair or replacement with contra-indication to or prohibitive risk of surgery.

Who may be able to join

None listed.

Who cannot join

  • Asymptomatic patients
  • Absence of severe mitral regurgitation or stenosis
  • Patient judged eligible for surgical treatment according to a specialized multidisciplinary meeting called "heart team" comprising at least one cardiothoracic surgeon, one interventional cardiologist, one echocardiographer, one clinical cardiologist and one anaesthesiologist.
  • Pregnant or breastfeeding women
  • Having not received information about the study or having expressed opposition to the use of their data

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jean-François OBADIA contact

+331 43 22 33 33

secretariat.registre@sfcardio.fr

Bernard IUNG contact

+331 43 22 33 33

secretariat.registre@sfcardio.fr

France3 sites, 3 recruiting

  • CHU Lyon

    Lyon

    Jean-Francois Obadia

    Recruiting

  • CHU Nantes

    Nantes

    Patrice Guérin

    Recruiting

  • Bichat Hospital

    Paris

    Bernard Iung

    Recruiting

Other trials in France

About this study

Official title: Management And Clinical Outcomes Of Patients With Severe Mitral Disease Not Suitable For Surgery: A Prospective, Multicentric, Observational Study

The objective of this study is to collect in a prospective registry all cases of French patients undergoing an assessment for percutaneous treatment of mitral valve disease on a native valve or due to deterioration after surgical valve repair or replacement. In these patients, valvular surgery should be considered contra-indicated or at prohibitive risk. This registry will evaluate the morbidity and mortality up to 24 months for those patients with severe mitral valve disease who are not included in a clinical trial. The association of demographic, clinical, laboratory, echocardiographic variables and treatment options with morbidity and mortality will be evaluated by univariate and multivariate analyses.

Read the detailed description

Patients with symptomatic severe mitral valve disease will have a medical evaluation visit (physical examination, ECG, biology) with transthoracic ± transesophageal echocardiography in each center. If the patient is considered not eligible for surgery by the heart-team and is not included in a clinical trial, the investigator informs the patient of the existence of the registry and verifies that it does not express opposition to the use of its clinical data.

In each participating center, demographic information, clinical, laboratory, echocardiographic and treatment options will be collected and reported in an electronic case report form (e-CRF). Each center will be responsible of patient monitoring, including phone call at 6 months and a medical visit at 1 and 2 years. Transthoracic echocardiography will also be performed at 1 year and 2 years.

Keywords
Mitral regurgitation, Mitral stenosis, Mitral valve repair deterioration, Bioprosthesis degeneration
Medical subject headings
Mitral Valve Insufficiency, Mitral Valve Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02925819
Study groupRoleWhat they receive
SEVERE MITRAL VALVE DISEASEAll patients with symptomatic severe mitral valve disease on a native valve or due to deterioration after surgical valve repair or replacement, and not eligible for surgery according to the heart-team.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All cause death and heart failure at 24 months

    Death from any cause or unscheduled hospitalization for heart failure at 24 months

    Measured: 24 months of follow-up

Secondary outcomes (5)

  1. Overall survival at 24 months

    The survival rate will be determined between the date of inclusion in the cohort and the date of occurrence of death, whatever the cause.

    Measured: 24 months of follow-up

  2. Survival without major cardiovascular event

    The rate of survival without major cardiovascular event rate will be determined between the date of inclusion and date of occurrence of a major cardiovascular event (unscheduled rehospitalisation for heart failure, stroke, death of cardiovascular, myocardial infarction).

    Measured: 24 months of follow-up

  3. Rate of unscheduled hospitalizations for heart failure

    Rate of unscheduled hospitalizations for heart failure at 24 months.

    Measured: 24 months of follow-up

  4. Functional evaluation

    It will be defined by changes in NYHA functional class at 24 months.

    Measured: 24 months of follow-up

  5. Early safety

    Defined as absence of all-cause mortality, all stroke, severe bleeding, acute kidney injury stage 2 or 3, major vascular complication, and valve related dysfunction requiring repeat interventional transcatheter procedure or surgery.

    Measured: Until Hospital Discharge, up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Oct 2016 (estimated)
  2. Study startOct 2016
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

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
500 participants (estimated)
Target duration
2 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT02925819
Sponsor's protocol ID
15.534
Acronym
MITRAGISTER
Status last verified
Jun 2026
First submitted
8 Sep 2016
Last updated
12 Jun 2026
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Nkomo VT, Gardin JM, Skelton TN, Gottdiener JS, Scott CG, Enriquez-Sarano M. Burden of valvular heart diseases: a population-based study. Lancet. 2006 Sep 16;368(9540):1005-11. doi: 10.1016/S0140-6736(06)69208-8.

    PubMed 16980116

  • Iung B, Baron G, Butchart EG, Delahaye F, Gohlke-Barwolf C, Levang OW, Tornos P, Vanoverschelde JL, Vermeer F, Boersma E, Ravaud P, Vahanian A. A prospective survey of patients with valvular heart disease in Europe: The Euro Heart Survey on Valvular Heart Disease. Eur Heart J. 2003 Jul;24(13):1231-43. doi: 10.1016/s0195-668x(03)00201-x.

    PubMed 12831818

  • Vahanian A, Alfieri O, Andreotti F, Antunes MJ, Baron-Esquivias G, Baumgartner H, Borger MA, Carrel TP, De Bonis M, Evangelista A, Falk V, Lung B, Lancellotti P, Pierard L, Price S, Schafers HJ, Schuler G, Stepinska J, Swedberg K, Takkenberg J, Von Oppell UO, Windecker S, Zamorano JL, Zembala M; ESC Committee for Practice Guidelines (CPG); Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC); European Association for Cardio-Thoracic Surgery (EACTS). Guidelines on the management of valvular heart disease (version 2012): the Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Eur J Cardiothorac Surg. 2012 Oct;42(4):S1-44. doi: 10.1093/ejcts/ezs455. Epub 2012 Aug 25. No abstract available.

    PubMed 22922698

  • De Bonis M, Lapenna E, La Canna G, Ficarra E, Pagliaro M, Torracca L, Maisano F, Alfieri O. Mitral valve repair for functional mitral regurgitation in end-stage dilated cardiomyopathy: role of the "edge-to-edge" technique. Circulation. 2005 Aug 30;112(9 Suppl):I402-8. doi: 10.1161/CIRCULATIONAHA.104.525188.

    PubMed 16159854

  • Alfieri O, Maisano F, De Bonis M, Stefano PL, Torracca L, Oppizzi M, La Canna G. The double-orifice technique in mitral valve repair: a simple solution for complex problems. J Thorac Cardiovasc Surg. 2001 Oct;122(4):674-81. doi: 10.1067/mtc.2001.117277.

    PubMed 11581597

  • Whitlow PL, Feldman T, Pedersen WR, Lim DS, Kipperman R, Smalling R, Bajwa T, Herrmann HC, Lasala J, Maddux JT, Tuzcu M, Kapadia S, Trento A, Siegel RJ, Foster E, Glower D, Mauri L, Kar S; EVEREST II Investigators. Acute and 12-month results with catheter-based mitral valve leaflet repair: the EVEREST II (Endovascular Valve Edge-to-Edge Repair) High Risk Study. J Am Coll Cardiol. 2012 Jan 10;59(2):130-9. doi: 10.1016/j.jacc.2011.08.067.

    PubMed 22222076

  • Maisano F, Franzen O, Baldus S, Schafer U, Hausleiter J, Butter C, Ussia GP, Sievert H, Richardt G, Widder JD, Moccetti T, Schillinger W. Percutaneous mitral valve interventions in the real world: early and 1-year results from the ACCESS-EU, a prospective, multicenter, nonrandomized post-approval study of the MitraClip therapy in Europe. J Am Coll Cardiol. 2013 Sep 17;62(12):1052-1061. doi: 10.1016/j.jacc.2013.02.094. Epub 2013 Jun 7.

    PubMed 23747789

  • Baldus S, Schillinger W, Franzen O, Bekeredjian R, Sievert H, Schofer J, Kuck KH, Konorza T, Mollmann H, Hehrlein C, Ouarrak T, Senges J, Meinertz T; German Transcatheter Mitral Valve Interventions (TRAMI) investigators. MitraClip therapy in daily clinical practice: initial results from the German transcatheter mitral valve interventions (TRAMI) registry. Eur J Heart Fail. 2012 Sep;14(9):1050-5. doi: 10.1093/eurjhf/hfs079. Epub 2012 Jun 8.

    PubMed 22685268

  • Armoiry X, Brochet E, Lefevre T, Guerin P, Dumonteil N, Himbert D, Cormier B, Piriou N, Gautier M, Messika-Zeitoun D, Romano M, Rioufol G, Warin Fresse K, Boudou N, Leclercq F, Bedossa M, Obadia JF. Initial French experience of percutaneous mitral valve repair with the MitraClip: a multicentre national registry. Arch Cardiovasc Dis. 2013 May;106(5):287-94. doi: 10.1016/j.acvd.2013.03.059. Epub 2013 May 28.

    PubMed 23769403

  • Obadia JF, Armoiry X, Iung B, Lefevre T, Mewton N, Messika-Zeitoun D, Cormier B, Berthiller J, Maucort-Boulch D, Boutitie F, Vaz B, Trochu JN, Vahanian A. The MITRA-FR study: design and rationale of a randomised study of percutaneous mitral valve repair compared with optimal medical management alone for severe secondary mitral regurgitation. EuroIntervention. 2015 Mar;10(11):1354-60. doi: 10.4244/EIJV10I11A232.

    PubMed 25798568

Questions about this trial

What is this clinical trial studying?

An observational study of Mitral Valve Disease, run by French Cardiology Society at 3 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 0 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 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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?

Contact Jean-François OBADIA (+331 43 22 33 33, secretariat.registre@sfcardio.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All cause death and heart failure at 24 months (time frame: 24 months of follow-up). 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 NCT02925819, which also lists 10 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 12 Jun 2026.

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