NCT00209274

Pivotal Study of a Percutaneous Mitral Valve Repair System

Pivotal Study: A Study of the Evalve Cardiovascular Valve Repair System - Endovascular Valve Edge-to-Edge REpair STudy (EVERESTIIRCT)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 279 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

EVEREST II Randomized Controlled Trial (RCT) is a prospective, multi-center, randomized study of the MitraClip® System in the treatment of mitral valve regurgitation, randomizing patients to MitraClip or mitral valve surgery. The EVEREST II High Risk Registry (HRR) study is a prospective multi-center study of the MitraClip System for the treatment of mitral valve regurgitation in high surgical risk patients. Enrollment in the RCT and HRR is closed. A continued access prospective, multi-center study (REALISM) of the MitraClip System in a surgical population (non-high risk arm) and a high surgical risk population (high risk arm) is ongoing. Enrollment in the non-high risk arm of REALISM is closed. Enrollment in the high risk arm of REALISM is ongoing. Patients enrolled in EVEREST II undergo 30-day, 6-month, 12-month, 18-month and 24-month clinical and echocardiographic follow-up, and then annually for 5 years.

Detailed description

Prospective, multi-center, randomized study of the safety and effectiveness of an endovascular approach to the treatment of mitral valve regurgitation using the Evalve Cardiovascular Valve Repair System (MitraClip® implant). A minimum of 279 evaluable patients randomized 2:1 to MitraClip or mitral valve surgery, respectively, are required to test the primary safety and effectiveness endpoints of the RCT. Enrollment in the RCT is now complete. 60 roll-in patients were enrolled under EVEREST II RCT. 38 clinical sites throughout the US and Canada have participated in the RCT and HRR. 37 US sites are participating in REALISM. The RCT is powered to test the hypothesis MitraClip has both superiority of safety and non-inferiority of effectiveness compared to mitral valve repair or replacement surgery. The HRR is powered to show lower mortality at 30 days with the MitraClip than predicted surgical mortality.

Conditions

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

Interventions

Type	Name	Description
DEVICE	Percutaneous mitral valve repair using MitraClip implant	MitraClip Implant
PROCEDURE	Mitral valve repair or replacement surgery	Repair or replacement of mitral valve

Timeline

• Start date: 2005-08-01
• Primary completion: 2009-11-01
• Completion: 2014-12-01
• First posted: 2005-09-21
• Last updated: 2018-11-07
• Results posted: 2017-09-05

Locations

1 site across 1 country: United States