Clinical Trials Logo
  1. Home
  2. Mitral Valve Disease
  3. NCT02925819

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

Mitral Valve Disease Clinical Trial

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

Clinical 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. 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02925819
Study type Observational [Patient Registry]
Source French Cardiology Society
Contact Jean-François OBADIA
Phone +331 43 22 33 33
Email secretariat.registre@sfcardio.fr
Status Recruiting
Phase
Start date October 2016
Completion date June 2026
View Details
See also
  Status Clinical Trial Phase
Completed NCT03283722 - PRESERVE-MITRAL Post-Market Registry
Not yet recruiting NCT06167213 - ALLIANCE Mitral: Safety and Effectiveness of SAPIEN X4 Transcatheter Heart Valve - Mitral N/A
Recruiting NCT06001489 - The Effects of 360-degree Virtual Reality on Pre-procedural Anxiety in Patients Awaiting Elective Cardiac Surgery Involving a Sternotomy N/A
Recruiting NCT06025149 - The Study on the Use of "UniLine" Bioprosthesis in the Treatment of Isolated Aortic and Mitral Valve Diseases
Completed NCT05193760 - Robustness Check of Placement and Measurement Algorithms for Blood Flow Measurement on Common Carotid Artery
Completed NCT05836558 - Are the Results of Minimally Invasive Mitral Valve Repair Still Satisfactory When Looked at Very Long-term?
Recruiting NCT05531253 - Respired Gases in Patients Post Cardiac Surgery
Completed NCT04045340 - Intraoperative Global Longitudinal Strain and Global Longitudinal Strain Rate as Predictors of Unfavorable Outcome in On-Pump Mitral Surgery
Active, not recruiting NCT04950192 - Philips Intracardiac Echocardiography (ICE) Clinical Registry
Completed NCT03438825 - PRediction of Early PostoperAtive Right vEntricular Failure in Mitral Valve Replacement/Repair Patients
Completed NCT02000544 - Clinical Evaluation of a Modular Extracorporeal Circulation Circuit N/A
Recruiting NCT03574311 - Preoperative Intravenous Ferric Carboxymaltose and Placebo in the Treatment of Patients Undergoing Cardiac Surgery Phase 4
Recruiting NCT06153563 - Evaluation of the Elasticity of the Mitral Valve
Active, not recruiting NCT03539458 - Feasibility Study of the Tendyne Mitral Valve System in Mitral Annular Calcification N/A
Recruiting NCT05898230 - Retrospective Clinical Data Collection on Carbomedics OptiForm Mitral Heart Valve
Withdrawn NCT01849757 - Comparison of Priming Constituents in Patients Undergoing CPB Assisted Cardiac Surgery: HES 130/0.4 or Albumin 5% N/A
Active, not recruiting NCT04147884 - A Feasibility Study of the Millipede Transcatheter Annuloplasty Ring System in Patients With Functional Mitral Regurgitation N/A
Completed NCT02097420 - HALO: A Single Arm Prospective Investigation of the SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve N/A
Enrolling by invitation NCT04067635 - Primary Mitral Regurgitation Repair
Recruiting NCT04954404 - Transcatheter Mitral Valve InterventiOn Single Center Registry in CHinese Patients With Mitral Valve Disease (TORCH-M) N/A