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A Randomized Study of the MitraClip Device in Heart Failure Patients With Clinically Significant Functional Mitral Regurgitation

NCT01772108 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2018-11-07

No results posted yet for this study

Summary

This trial is a randomized study of the MitraClip device in heart failure patients with clinically significant functional mitral regurgitation. A hierarchical composite of all-cause mortality and recurrent heart failure hospitalizations is hypothesized to occur at a lower rate with the use of the MitraClip device in addition to optimal standard medical therapy compared to optimal standard of care therapy alone.

Conditions

Interventions

DEVICE

MitraClip

The MitraClip System includes a MitraClip device, a Steerable Guide Catheter, and a MitraClip Delivery System that enables placement of the MitraClip device on the mitral valve leaflets

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Piotr Ponikowski, MD, PhD · Military Hospital, Medical University, Wroclaw, Poland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2014-12-31
Completion
2015-01-31

Countries

  • Austria
  • Belgium
  • Denmark
  • Finland
  • Germany
  • Italy
  • Netherlands
  • Spain
  • Sweden
  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

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 NCT01772108 on ClinicalTrials.gov