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NCT Number: NCT02925819

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

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.

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Key information

Conditions

Mitral Valve Disease Cardiovascular Diseases Heart Diseases Heart Valve Diseases Mitral Valve Insufficiency Mitral Valve Stenosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Lyon, Lyon, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • Aged over 18 years
  • Presenting with severe mitral valve stenosis or regurgitation regardless of etiology (primary mitral regurgitation, secondary mitral regurgitation, deterioration of mitral valve repair or bioprosthesis, mitral annular calcification)
  • Symptomatic (NYHA functional class II-IV) despite optimized medical therapy
  • Judged not 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.
  • Having received information about the study and not expressing opposition to the use of their data
  • Patient not included in a clinical trial

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. All cause death and heart failure at 24 months

    Time frame: 24 months of follow-up

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

Secondary outcomes

  1. Overall survival at 24 months

    Time frame: 24 months of follow-up

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

  2. Survival without major cardiovascular event

    Time frame: 24 months of follow-up

    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).

  3. Rate of unscheduled hospitalizations for heart failure

    Time frame: 24 months of follow-up

    Rate of unscheduled hospitalizations for heart failure at 24 months.

  4. Functional evaluation

    Time frame: 24 months of follow-up

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

  5. Early safety

    Time frame: Until Hospital Discharge, up to 6 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Bernard IUNG

CONTACT

[email protected]

+331 43 22 33 33

Jean-François OBADIA

CONTACT

[email protected]

+331 43 22 33 33

Sponsors and collaborators

Lead sponsor

French Cardiology Society

Other

Registry information

Official study title

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

Acronym: MITRAGISTER

Important dates

Study start
2016
Primary completion
2026
Study completion
2026
First posted
Oct 6, 2016
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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