Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00209274
Status:
COMPLETED
Last Update Posted:
2018-11-07
First Post:
2005-09-13
Brief Title:
Pivotal Study of a Percutaneous Mitral Valve Repair System
Sponsor:
Abbott Medical Devices
Organization:
Abbott Medical Devices
Study Overview
Official Title:
Pivotal Study A Study of the Evalve Cardiovascular Valve Repair System - Endovascular Valve Edge-to-Edge REpair STudy EVERESTIIRCT
Status:
COMPLETED
Status Verified Date:
2018-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EVERESTIIRCT
Brief 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 21 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
A minimum of 279 evaluable patients randomized 21 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Protocol 0401 | None | None | None |