Ignite Creation Date:
2024-05-06 @ 1:59 AM
Last Modification Date:
2024-10-26 @ 11:12 AM
Study NCT ID:
NCT01940120
Status:
COMPLETED
Last Update Posted:
2018-11-07
First Post:
2013-09-03
Brief Title:
EVEREST II Pivotal Study High Risk Registry HRR
Sponsor:
Abbott Medical Devices
Organization:
Abbott Medical Devices
Study Overview
Official Title:
A Study of the Evalve Cardiovascular Valve Repair MitraClip System Endovascular Valve Edge-to-Edge REpair STudy EVEREST II EVEREST II High Risk Registry
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:
HRR
Brief 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
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
Detailed Description:
The EVEREST II HRR is a single-arm prospective multicenter clinical trial enrolling high surgical risk patients of the EVEREST II study NCT00209274
Patients were considered high surgical risk if either their Society of Thoracic Surgery STS predicted operative mortality risk was 12 or the surgeon investigator determined the patient to be high risk 12 predicted operative mortality risk due to the presence of at a minimum one of the following pre-specified risk factors
Porcelain aorta or mobile ascending aortic atheroma
Post-radiation mediastinum
Previous mediastinitis
Functional MR with ejection fraction EF 40
Over 75 years old with EF 40
Prior re-operation with patent grafts
Two or more prior chest surgeries
Hepatic cirrhosis
Three or more of the following STS high risk factors
i Creatinine 25 mgdL ii Prior chest surgery iii Age over 75 iv EF 35
Upon completion of enrollment in the HRR a process was initiated to ensure patient consent to participate in a Concurrent Control CC group was in place Patients were identified to determine survival through 12 months with current standard of care treatmentCC patients were derived from a cohort of patients screened for enrollment in the HRRyet did not enroll All patients had moderate-to-severe 3 or severe 4 MR based on transthoracic echocardiography TTE To be considered eligible for inclusion in the CC group the patient had to be classified as high surgical risk using the same criteria used for the HRR Upon follow-up with the clinical sites it was determined that some of the initially identified patients with moderate-to-severe 3 or severe 4 MR met the criteria for high surgical risk Of these patients some were not included due to lack of Institutional Review Board IRB approval at the site lack of informed consent and unable to be contacted The remaining patients make up the CC group
Patients were considered high surgical risk if either their Society of Thoracic Surgery STS predicted operative mortality risk was 12 or the surgeon investigator determined the patient to be high risk 12 predicted operative mortality risk due to the presence of at a minimum one of the following pre-specified risk factors
Porcelain aorta or mobile ascending aortic atheroma
Post-radiation mediastinum
Previous mediastinitis
Functional MR with ejection fraction EF 40
Over 75 years old with EF 40
Prior re-operation with patent grafts
Two or more prior chest surgeries
Hepatic cirrhosis
Three or more of the following STS high risk factors
i Creatinine 25 mgdL ii Prior chest surgery iii Age over 75 iv EF 35
Upon completion of enrollment in the HRR a process was initiated to ensure patient consent to participate in a Concurrent Control CC group was in place Patients were identified to determine survival through 12 months with current standard of care treatmentCC patients were derived from a cohort of patients screened for enrollment in the HRRyet did not enroll All patients had moderate-to-severe 3 or severe 4 MR based on transthoracic echocardiography TTE To be considered eligible for inclusion in the CC group the patient had to be classified as high surgical risk using the same criteria used for the HRR Upon follow-up with the clinical sites it was determined that some of the initially identified patients with moderate-to-severe 3 or severe 4 MR met the criteria for high surgical risk Of these patients some were not included due to lack of Institutional Review Board IRB approval at the site lack of informed consent and unable to be contacted The remaining patients make up the CC group
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