Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06340997
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-02
First Post:
2023-12-14
Brief Title:
Impact of Percutaneous Transvenous Mitral Commissurotomy on The Left Atrial Appendage Function in Patients With Mitral Stenosis
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
Impact of Percutaneous Transvenous Mitral Commissurotomy on The Left Atrial Appendage Function in Patients With Mitral Stenosis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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:
Evaluation of the effect of PTMC on LAA function by TEE at least one month after the procedure and its effectiveness in prevention of thrombi formation and cerebrovascular complications
Detailed Description:
Mitral stenosis MS is a disabling disease that limits the normal physical abilities of patients and considered as a major reason for hospital admissions The leading cause of MS globally is rheumatic heart diseaseRHD which remains common in economically developing countries and continues to be a significant cause of morbidity and mortality
Chronic pressure and volume overload imposed by MS causes left atrial LA and Left Atrial Appendage LAA dysfunction leading to reduced blood flow velocities thereby producing stasis of blood reduced LA and LAA ejection fraction and atrial fibrillation AF
These factors predispose to formation of LA and LAA thrombi in MS and result in thromboembolic episodes Risk of cerebrovascular accident CVA is increased approximately five-fold in non-rheumatic AF and 17-fold in patients with MS with AF Even patients of MS in sinus rhythm with depressed LA and LAA function are at increased risk of CVA Assessment of LAA function is helpful in predicting the risk of thromboembolism
PTMC can improve the function of the LAA by reducing the left atrial pressure and increasing the blood flow through the mitral valve
Echocardiography particularly transesophageal echocardiography TEE is currently the modality of choice for evaluation of the LAA Transesophageal echocardiography TEE allows semi-invasive highly accurate imaging of the functional efficiency of LAA by LAA Doppler and Doppler tissue imaging DTI
MS causes decreased LAA Doppler and DTI velocities in patients even with sinus rhythm So this study aims to evaluate effect of successful PTMC on LAA function by TEE Doppler and DTI doppler tissue imaging
Fractional area change FAC The FAC is a measure of the percentage of change in the area of the LAA during systole A higher FAC indicates a more contractile LAA
Chronic pressure and volume overload imposed by MS causes left atrial LA and Left Atrial Appendage LAA dysfunction leading to reduced blood flow velocities thereby producing stasis of blood reduced LA and LAA ejection fraction and atrial fibrillation AF
These factors predispose to formation of LA and LAA thrombi in MS and result in thromboembolic episodes Risk of cerebrovascular accident CVA is increased approximately five-fold in non-rheumatic AF and 17-fold in patients with MS with AF Even patients of MS in sinus rhythm with depressed LA and LAA function are at increased risk of CVA Assessment of LAA function is helpful in predicting the risk of thromboembolism
PTMC can improve the function of the LAA by reducing the left atrial pressure and increasing the blood flow through the mitral valve
Echocardiography particularly transesophageal echocardiography TEE is currently the modality of choice for evaluation of the LAA Transesophageal echocardiography TEE allows semi-invasive highly accurate imaging of the functional efficiency of LAA by LAA Doppler and Doppler tissue imaging DTI
MS causes decreased LAA Doppler and DTI velocities in patients even with sinus rhythm So this study aims to evaluate effect of successful PTMC on LAA function by TEE Doppler and DTI doppler tissue imaging
Fractional area change FAC The FAC is a measure of the percentage of change in the area of the LAA during systole A higher FAC indicates a more contractile LAA
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None