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

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ClinicalTrials.gov Identifier: NCT02925819
Recruitment Status : Recruiting
First Posted : October 6, 2016
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
French Cardiology Society

Brief 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. 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.

Condition or disease
Mitral Valve Disease

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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Management And Clinical Outcomes Of Patients With Severe Mitral Disease Not Suitable For Surgery: A Prospective, Multicentric, Observational Study
Actual Study Start Date : October 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : June 2022

Group/Cohort
SEVERE MITRAL VALVE DISEASE
All 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.



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02925819


Contacts
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Contact: Jean-François OBADIA +331 43 22 33 33 secretariat.registre@sfcardio.fr
Contact: Bernard IUNG +331 43 22 33 33 secretariat.registre@sfcardio.fr

Locations
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France
CHU Lyon Recruiting
Lyon, France
Contact: Jean-Francois Obadia         
CHU Nantes Recruiting
Nantes, France
Contact: Patrice Guérin         
Bichat Hospital Recruiting
Paris, France
Contact: Bernard Iung         
Sponsors and Collaborators
French Cardiology Society
Investigators
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Principal Investigator: Jean-François OBADIA CHU Lyon
Principal Investigator: Bernard IUNG Assistance Publique - Hôpitaux de Paris
Principal Investigator: Patrice GUERIN CHU Nantes

Additional Information:

Publications:
Vahanian A, Alfieri O, Andreotti F, Antunes MJ, Barón-Esquivias G, Baumgartner H, Borger MA, Carrel TP, De Bonis M, Evangelista A, Falk V, Lung B, Lancellotti P, Pierard L, Price S, Schäfers 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.

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Responsible Party: French Cardiology Society
ClinicalTrials.gov Identifier: NCT02925819     History of Changes
Other Study ID Numbers: 15.534
First Posted: October 6, 2016    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by French Cardiology Society:
Mitral regurgitation
Mitral stenosis
Mitral valve repair deterioration
Bioprosthesis degeneration
Additional relevant MeSH terms:
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Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases