CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 78 enrolled
Drug / intervention
Percutaneous mitral valve repair using 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/NCT01940120
NCT01940120N/ACompleted
CompareCT.gov

A Study of the Evalve® Cardiovascular Valve Repair (MitraClip®) System Endovascular Valve Edge-to-Edge REpair STudy (EVEREST II) EVEREST II High Risk Registry

Abbott Medical Devices·interventional·Posted Sep 12, 2013·Updated Nov 7, 2018

In Brief

A clinical study evaluating Percutaneous mitral valve repair using MitraClip implant for Mitral Valve Insufficiency and 4 related conditions. Completed, enrolled 78 participants across 2 sites.

Detailed 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).

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
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 12, 2013
Enrollment StartFeb 1, 2007
Primary CompletionMar 1, 2008
Study CompletionFeb 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 12.8 years ago

Interventions

Percutaneous mitral valve repair using MitraClip implantdevice

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