Ignite Creation Date:
2024-05-06 @ 1:56 AM
Last Modification Date:
2024-10-26 @ 11:11 AM
Study NCT ID:
NCT01931956
Status:
COMPLETED
Last Update Posted:
2018-12-04
First Post:
2013-08-27
Brief Title:
Real World Expanded Multicenter Study of the MitraClip System REALISM
Sponsor:
Abbott Medical Devices
Organization:
Abbott Medical Devices
Study Overview
Official Title:
A Continued Access Registry of the Evalve MitraClip System EVEREST II Real World Expanded Multicenter Study of the MitraClip System REALISM
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:
REALISM
Brief 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
Detailed Description:
The EVEREST II REALISM study REALISM study is a continued access registry designed for continued data collection on the use of Abbott Vasculars MitraClip System MitraClip Device under more real world conditions After the completion of enrollment in the pivotal EVEREST II Randomized Controlled Trial RCT NCT00209274 and EVEREST II High Risk Registry Study NCT01940120 continued access to the technology was warranted to collect additional safety and effectiveness data on the MitraClip Device This continued access study was approved by FDA on November 21 2008 G030064 There are two arms High Risk and Non-High Risk in the REALISM study 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 Enrollment in the Non-High Risk arm of the study concluded on April 14 2011 and enrollment in the High Risk arm concluded on December 19 2013
REALISM is a prospective multi-center 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 Patients with moderate-to-severe 3 or severe 4 mitral regurgitation MR as determined by the site from a transthoracic echocardiogram TTE were considered for enrollment in this study The TTE and a transesophageal echocardiogram TEE are used to assess eligibility criteria for MR severity valve anatomy and left ventricular parameters
REALISM is a prospective multi-center 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 Patients with moderate-to-severe 3 or severe 4 mitral regurgitation MR as determined by the site from a transthoracic echocardiogram TTE were considered for enrollment in this study The TTE and a transesophageal echocardiogram TEE are used to assess eligibility criteria for MR severity valve anatomy and left ventricular parameters
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
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 |
|---|---|---|---|
| 0401 | OTHER | Abbott Vascular | None |