Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06547788
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-07
Brief Title:
LEFT ATRIAL MONITORING IN PATIENTS BEFORE AND AFTER MITRAL SURGERY - LAMBDA STUDY
Sponsor:
None
Organization:
None
Study Overview
Official Title:
LEFT ATRIAL MONITORING IN PATIENTS BEFORE AND AFTER MITRAL SURGERY - LAMBDA STUDY
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LAMBDA
Brief Summary:
Mitral valve leakage or mitral regurgitation MR is associated with heart failure symptoms including shortness of breath fatigue irregular heart rate When left untreated it may cause death Patients with MR can be divided in two broad groups those with primary MR caused by disease of the mitral valve structures and those with secondary MR due to dilation of the heart chambers Our study focuses on patients with primary MR
The standard treatment for severe symptomatic primary MR is mitral valve surgery a type of open-heart surgery The outcomes following this procedure are excellent however a subset of patients continue to experience heart failure symptoms after surgery due to very high pressures in the heart more specifically in the left atrium which is one of the four heart chambers This is called functional mitral stenosis FMS
Previous studies have shown that creating a small opening between the left and right atria can help relieve the pressure inside the left atrium We would like to determine whether creating this opening between the two atria at the time of mitral valve surgery can help prevent FMS To answer this question we will study two groups of patients who need mitral valve surgery for primary MR The first group will undergo mitral valve surgery along with the creation of the opening between the two atria The second group will undergo mitral valve surgery alone We will then compare the outcomes between both groups namely with regards to their heart failure symptoms after open-heart surgery
The standard treatment for severe symptomatic primary MR is mitral valve surgery a type of open-heart surgery The outcomes following this procedure are excellent however a subset of patients continue to experience heart failure symptoms after surgery due to very high pressures in the heart more specifically in the left atrium which is one of the four heart chambers This is called functional mitral stenosis FMS
Previous studies have shown that creating a small opening between the left and right atria can help relieve the pressure inside the left atrium We would like to determine whether creating this opening between the two atria at the time of mitral valve surgery can help prevent FMS To answer this question we will study two groups of patients who need mitral valve surgery for primary MR The first group will undergo mitral valve surgery along with the creation of the opening between the two atria The second group will undergo mitral valve surgery alone We will then compare the outcomes between both groups namely with regards to their heart failure symptoms after open-heart surgery
Detailed Description:
None
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