CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 55 enrolled
Drug / intervention
Percutaneous mitral valve repair (MitraClip Implant)device
Likely dose
Percutaneous mitral valve repair using the Evalve MitraClip Cardiovascular Valve Repair System (endovascular implant)AI-extracted
Key inclusion· 3
  • ✓Moderate to severe mitral regurgitation, symptomatic or asymptomatic with evidence of left ventricular dysfunction
  • ✓Regurgitation originates from the central two-thirds of the valve
  • ✓Qualify as a candidate for mitral valve surgery including cardiopulmonary bypass
Key exclusion· 4
  • ✕Ejection fraction less than 30%
  • ✕Endocarditis
  • ✕Rheumatic heart disease
  • ✕Renal insufficiency

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

Search/NCT00209339
NCT00209339Phase 2Completed
CompareCT.gov

A Study of the Evalve Cardiovascular Valve Repair System Endovascular Valve Edge-to-Edge REpair STudy (EVEREST I).

Abbott Medical Devices·interventional·Posted Sep 21, 2005·Updated Nov 7, 2018

In Brief

A Phase 2 clinical trial evaluating Percutaneous mitral valve repair (MitraClip Implant) for Mitral Valve Insufficiency and 4 related conditions. Completed, enrolled 55 participants across 1 site.

Detailed Summary

Prospective, multi-center, Phase I study of the Evalve Cardiovascular Valve Repair System (CVRS) in the treatment of mitral valve regurgitation. Patients will undergo 30-day, 6 month, 12 month, and 5 year clinical follow-up.

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

Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 21, 2005
Enrollment StartJul 1, 2003
Primary CompletionFeb 1, 2006
Study CompletionOct 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 20.8 years ago

Interventions

Percutaneous mitral valve repair (MitraClip Implant)device

Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.