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A Multicenter, Randomized, Controlled Study to Assess Mitral vAlve reconsTrucTion for advancEd Insufficiency of Functional or iscHemic ORigiN

NCT02371512 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2017-08-01

No results posted yet for this study

Summary

Study to assess mitral valve therapy for advanced insufficiency of functional or ischemic origin in patients with moderate-to-severe mitral regurgitation (MR) of primarily functional pathology and reduced left ventricular function considered to be at high surgical risk

Conditions

  • Mitral Valve Insufficiency

Interventions

DEVICE

MitraClip system (Abbott Vascular, Menlo Park, USA)

Valve repair with the MitraClip system (Abbott Vascular, Menlo Park, USA) consists of a steerable guide through which a Clip Delivery System is advanced to the left atrium.

PROCEDURE

Mitral valve surgery

Mitral valve surgery or mitral valve replacement (technique and access at the discretion of the participating surgical center, MACE procedure and tricuspid annuloplasty possible)

Sponsors & Collaborators

  • The Clinical Trials Centre Cologne

    collaborator OTHER

  • Universitätsklinikum Köln

    lead OTHER

Principal Investigators

  • Stephan Baldus, Prof. Dr. med. · Herzzentrum Uniklinik Köln

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2019-12-31
Completion
2019-12-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02371512 on ClinicalTrials.gov