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Real World Expanded Multicenter Study of the MitraClip® System (REALISM)

NCT01931956 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 965

Last updated 2018-12-04

Study results available
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Summary

Prospective, multicenter, continued access registry of the MitraClip® Cardiovascular Valve Repair System in the treatment of mitral valve regurgitation. Patients will undergo 30-day, 6-month, 12-month, 36-month and 60-month clinical follow-up. The study consists of two arms: a High Risk group (NCT01940120) and a Non-High Risk group (NCT00209274) . Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU).

Conditions

  • Mitral Valve Insufficiency
  • Mitral Valve Regurgitation
  • Mitral Valve Incompetence
  • Mitral Regurgitation
  • Mitral Insufficiency

Interventions

DEVICE

MitraClip® implant

Percutaneous mitral valve repair using MitraClip implant

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Ted Feldman, M.D. Feldman, M.D. · Endeavor Health

  • Donald D Glower Jr., MD · Duke University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-22
Primary Completion
2015-02-28
Completion
2018-06-30
FDA Device
Yes

Countries

  • United States

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 NCT01931956 on ClinicalTrials.gov