Surgical Correction of Moderate Ischemic Mitral Regurgita... | NCT00394797

Studies
Surgical Correction of Moderate Ischemic Mitral Regurgitation

NCT00394797

Sponsor

Shaare Zedek Medical Center

Status

Completed

Last Update Posted

Jun 1, 2011Estimated

Enrollment

Not provided

Phase

Not provided

Conditions

Moderate Ischemic Mitral Regurgitation

Interventions

mitral valve annuloplasty

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Oct 31, 2006

First Submission Date that Met QC Criteria

Oct 31, 2006

First Posted Date

Nov 1, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 31, 2011

Last Update Posted Date

Jun 1, 2011Estimated

Description Module

Brief Summary

The purpose of this study is to try and determine whether repair of moderate ischemic mitral regurgitation at the time of coronary bypass graft surgery (CABG) has an impact on survival.We will compare patients undergoing CABG + mitral repair or CABG only groups. Primary endpoints include late survival. Secondary endpoints include event free survival, symptoms, and echocardiographic outcomes.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
mitral valve annuloplasty	Procedure

Measure	Description	Time Frame
survival at 1,5 and 10 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients undergoing coronary bypass surgery who have moderate degree of ischemic MR

Exclusion Criteria:

etiology of mitral regurgitation other than ischemic, degree of regurgitation other than moderate.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients undergoing coronary bypass surgery who have moderate degree of ischemic MR

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Shuli Silberman, MD	Shaare Zedek Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shaare Zedek Medical Center		Jerusalem		91031	Israel

Intervention Browse Module

MeSH Terms

ID	Term
D058386	Mitral Valve Annuloplasty

Ancestor Terms

ID	Term
D058385	Cardiac Valve Annuloplasty
D006348	Cardiac Surgical Procedures
D013504	Cardiovascular Surgical Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided