Ignite Creation Date:
2024-05-05 @ 9:03 PM
Last Modification Date:
2024-10-26 @ 9:58 AM
Study NCT ID:
NCT00807040
Status:
COMPLETED
Last Update Posted:
2019-03-15
First Post:
2008-12-10
Brief Title:
Comparing the Effectiveness of Repairing Versus Replacing the Hearts Mitral Valve in People With Severe Chronic Ischemic Mitral Regurgitation
Sponsor:
Icahn School of Medicine at Mount Sinai
Organization:
Icahn School of Medicine at Mount Sinai
Study Overview
Official Title:
Evaluation of Outcomes Following Mitral Valve RepairReplacement in Severe Chronic Ischemic Mitral Regurgitation
Status:
COMPLETED
Status Verified Date:
2019-02
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:
None
Brief Summary:
People with coronary artery disease CAD or people who have had a heart attack may develop a leak in the mitral valve of their heart and may therefore need to undergo surgery to fix the valve The best way to fix the mitral valve remains undetermined This study will evaluate whether it is better for people with severe mitral valve leakage to undergo a mitral valve replacement procedure or a mitral valve repair procedure
Detailed Description:
CAD occurs when the arteries that supply blood to the heart become blocked as a result of plaque buildup In severe cases CAD can cause chest pain shortness of breath and heart attack After a heart attack some people may develop a leak in the mitral valve of the heart This condition is known as ischemic mitral regurgitation IMR and it can cause blood to flow backward into the heart If left untreated severe IMR can lead to heart failure or serious heart rhythm irregularities known as arrhythmias People with severe mitral valve leakage routinely undergo one of two surgical procedures to fix the mitral valve a mitral valve repair procedure in which a surgical ring is used to repair the valve or a mitral valve replacement procedure in which the damaged valve is replaced with a new one Currently there is no consensus in the medical community as to which procedure is more beneficial The purpose of this study is to determine whether people with severe mitral valve regurgitation should undergo a mitral valve repair procedure or a mitral valve replacement procedure
This study will enroll people with CAD who have severe mitral regurgitation At a baseline study visit participants will undergo a physical examination blood collection neurocognitive tests and questionnaires regarding medical history medication history and quality of life In the operating room participants will be randomly assigned to undergo either the mitral valve repair procedure or the mitral valve replacement procedure Blood urine and tissue samples may be collected from participants after the surgery this is optional and will only be done with prior approval from participants All participants will attend study visits at Day 30 and Months 6 12 and 24 At each visit participants will take part in a medication history review a physical examination an echocardiogram a cardiopulmonary exercise test neurocognitive tests and quality of life surveys
This study will enroll people with CAD who have severe mitral regurgitation At a baseline study visit participants will undergo a physical examination blood collection neurocognitive tests and questionnaires regarding medical history medication history and quality of life In the operating room participants will be randomly assigned to undergo either the mitral valve repair procedure or the mitral valve replacement procedure Blood urine and tissue samples may be collected from participants after the surgery this is optional and will only be done with prior approval from participants All participants will attend study visits at Day 30 and Months 6 12 and 24 At each visit participants will take part in a medication history review a physical examination an echocardiogram a cardiopulmonary exercise test neurocognitive tests and quality of life surveys
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 |
|---|---|---|---|
| U01HL088942 | NIH | None | None |
| U01 HL088942-01-2 | None | None | None |
| 595 | OTHER | Ct Surgery Network Research Group | httpsreporternihgovquickSearchU01HL088942 |