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EVEREST II Pivotal Study High Risk Registry (HRR)

NCT01940120 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2018-11-07

Study results available
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Summary

Prospective, multi-center, single arm registry. Clinical follow-up at discharge, 30 days, 6, 12, 18 and 24, months, and 3, 4 and 5 years.

Concurrent Control (CC) group identified retrospectively from the patients screened for the HRR who did not enroll; patient survival determined at 12 months. NCT00209274 (EVEREST II RCT) Intended use Percutaneous reduction of clinically significant mitral regurgitation in symptomatic patients who are considered to be high risk for operative mortality (high surgical risk).

Conditions

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

Interventions

DEVICE

Percutaneous mitral valve repair using MitraClip implant

Procedure/Surgery: Mitral valve repair or replacement surgery Repair or replacement of mitral valve

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Ted Feldman, M.D. · Endeavor Health

  • Donald G Glower Jr.,, M.D. · Duke University Medical Center, Department of Surgery

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2008-03-31
Completion
2013-02-28

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 NCT01940120 on ClinicalTrials.gov