CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 965 enrolled
Drug / intervention
MitraClip® implantdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01931956
NCT01931956N/ACompleted
CompareCT.gov

A Continued Access Registry of the Evalve® MitraClip® System: EVEREST II Real World Expanded Multicenter Study of the MitraClip System (REALISM)

Abbott Medical Devices·interventional·Posted Aug 30, 2013·Updated Dec 4, 2018

In Brief

A clinical study evaluating MitraClip® implant for Mitral Valve Insufficiency and 4 related conditions. Completed, enrolled 965 participants across 38 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMitral Valve Insufficiency, Mitral Valve Regurgitation, Mitral Valve Incompetence, Mitral Regurgitation, Mitral Insufficiency
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 30, 2013
Enrollment StartJan 22, 2009
Primary CompletionFeb 1, 2015
Study CompletionJun 1, 2018
TodayJul 2, 2026
Enrollment to primary: 6.0 yearsPosted 12.8 years ago

Interventions

MitraClip® implantdevice

Percutaneous mitral valve repair using MitraClip implant