MITRA-PRO

Overview
Related items

With over 15,000 implantations worldwide to date, the MitraClip procedure has established itself as a treatment for patients with mitral valve insufficiency. It is the only minimally invasive, transcatheter mitral valve therapy available. A standardised, multimodal approach ("MitraScore") has been developed for the assessment of residual mitral valve regurgitation after MitraClip implantation. It has been shown that a low MitraScore is associated with a better long-term outcome after MitraClip implantation (Horstkotte et al. 2015). However, despite the large number of procedures performed to date, there is little study data on MitraClip therapy. This observational study therefore aims to evaluate the efficacy and safety of MitraClip implantation by recording the MitraScore and 1-year mortality after implantation.

Programme: ZKS-UWH

SEEK ID: https://ldh.zks-uwh.imise.uni-leipzig.de/projects/7

Public web page: Not specified

NFDI4Health PALs: René Geißen, Stephanie Knippschild

Project start date: 1st Aug 2016

Extended Metadata (Nfdi4Health MDS 3.3)

Expand All Collapse All

Id of the project(*) : nfdi4health-29969

Resource classification(*)

Type of the resource : Study

Title(s)/name(s) of the Project

Title/name : MitraPro: A prospective registry study on 1-year mortality and prognostic significance of the MitraScore after MitraClip implantation in patients with mitral valve insufficiency
Language of the title/name : English

Acronym(s) of the Project

Acronym : MitraPro
Language of the acronym : German

Description(s) of the Project

Description : The aim of this multicentre observational study is to find out whether a better outcome of the MitraClip procedure - characterised by a MitraScore of 1-3 - is associated with a lower 1-year mortality than implantation results characterised by a MitraScore of >= 4. The MitraScore was developed as a standardised multimodal method to estimate the intraprocedural success of MitraClip implantation using a combination of transesophageal echocardiography, levocardiography, TEE bubble assessment and measurement of left atrial pressure. Apart from statistically assessing the difference in 1-year mortality of patients with a MitraScore of 1-3 compared to patients with a MitraScore of >= 4, this patient registry aims to provide data on the efficacy and safety of MitraClip therapy. A total of 1550 patients are expected to be included in 35 trial centres in Germany.
Language of the description : English

Keyword(s) describing the Project

Keyword(*) : Mitraclip, assessment of mitral valve insufficiency

Language(s) of the project : German

Contributor(s) of the Project

Is it a personal or organisational contribution?(*) : Organisational
Details about the contributing organisation(s)/institution(s)/group(s)
Contributor type(*) : Sponsor (primary)
Funding identifier(s) : Abbott
Name of the organisation/institution/group(*) : ZKS-UW/H
Details about the contributing person(s)
Contributor type(*) : Not specified
Given name(*) : Not specified
Family name(s)(*) : Not specified
Digital identifier(s)
Identifier(*) : Not specified
Scheme(*) : Not specified
Email address : zks@uni-wh.de
Phone number : Not specified
Organisation(s) associated with the contributor
Name(*) : Witten/Herdecke University
Address : Alfred-Herrhausen-Str. 50, 58448, Witten, Germany
Web page : https://www.uni-wh.de/euer-campus/institute-zentren-und-ags/zentrum-fuer-klinische-studien-zks-uwh
Digital identifier(s)
Identifier(*) : 00yq55g44
Scheme(*) : ROR

Alternative identifiers

Type of the registry(*) : DRKS
Identifier(*) : DRKS00012288

Characteristics of the Project

Is it an interventional or non-interventional Project? : Non-interventional
Specification of the type of the Project
Interventional Project type : []
Non-interventional Project type : Cohort
Primary health condition(s) or disease(s) considered in the Project
Primary health condition or disease name(*) : Mitral valve insufficiency
Terminology/classification(*) : ICD-10
Code of the health condition or disease : I34.0
Groups of diseases or conditions(*)
Which groups of diseases or conditions were the data collected on? : Diseases of the circulatory system (IX)
On which diseases or conditions were the data collected? : []
Collects mortality data? : Yes, with cause of death
Administrative information about the Project
Status of the ethics committee approval : Request for approval submitted, approval granted
Overall Project status : Ongoing (IV): Recruitment and data collection completed, but data quality management ongoing
Participants enrolled by invitation? : Yes
Start date : 1 August 2016
End date : 9 April 2020
Mono- or multicentric? : Multicentric
Number of centers : 26
One or more data providers? : Not specified
Number of data providers : Not specified
Primary subject(*) : Person
Eligibility criteria for Project participants
Eligibility criteria: Minimum age
Minimum eligible age(*) : 18
Unit of age(*) : Years
Eligibility criteria: Maximum age
Maximum eligible age(*) : 100
Unit of age(*) : Years
Eligible gender : Male, Female, Diverse
Inclusion criteria : - mitraclip implantation due to severe mitral valve insufficiency; - given informed consent
Exclusion criteria : - Placement in an institution on the basis of a court or official order; - due to study design no further exclusion criteria
Population of the Project(*)
Coverage : National
Country(ies) : Germany
Region(s) and/or city(ies) : Not specified
Interventions of the Project
Name of the intervention(*) : Not specified
Type of the intervention : Not specified
Additional information about the intervention : Not specified
Name(s) of the arm(s) associated with the given intervention : Not specified
Exposures of the Project
Name of the exposure : Not specified
Type of the exposure : Not specified
Additional information about the exposure : Not specified
Name(s) of the group(s) associated with the given exposure : Not specified
Outcome measures in the Project
Name of the outcome measure(*) : Mortality
Description of the outcome measure : Survival after MitraClip implantation is measured
Type of the outcome measure : Primary
Time point(s) of assessment : 1/3/5 Years
Name of the outcome measure(*) : MitraScore
Description of the outcome measure : The MitraScore is a new prognostic tool to measure the severity of mitralvalve insufficiency
Type of the outcome measure : Secondary
Time point(s) of assessment : directly while implantation of MitraClip
Additional information about the Project : Not specified
Additional assessments/measurements in the Project : []
Data sharing strategy of the Project(*)
Is it planned to share the data?(*) : Yes, there is a plan to make data available
Supporting documents available in addition to the data : Study protocol
When and for how long will the data be available? : Not specified
Criteria for data access : Not specified
Additional information about data sharing : Not specified
DataSHIELD/Opal infrastructure available? : Not specified
Link to data request application : Not specified
Web page with additional information about data sharing : Not specified
Record linkage possible? : false
Non-interventional aspects of the Project
Temporal design : Prospective
Target follow-up duration of the Project
Target follow-up duration(*) : 1
Unit of time(*) : Years
Number of follow-ups conducted : 5
Biosamples retained in a biorepository : None retained
Specific types of retained biosamples : Not specified
Interventional aspects of the Project
Numerical phase : Not specified
Masking of intervention(s) assignment
Masking implemented? : Not specified
Who is masked? : []
Additional information about masking : Not specified
Type of allocation of participants to an arm : Not specified
Off-label use of a drug product : Not specified

Annotated Properties

Topic annotations

Cardiology

MITRA-PRO

Related items