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Impact of Percutaneous Transvenous Mitral Commissurotomy on The Left Atrial Appendage Function in Patients With Mitral Stenosis.

Impact of Percutaneous Transvenous Mitral Commissurotomy on The Left Atrial Appendage Function in Patients With Mitral Stenosis.

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06340997
Enrollment
25
Registered
2024-04-02
Start date
2024-07-01
Completion date
2027-08-01
Last updated
2024-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mitral Stenosis

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 disease(RHD), 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.

Interventions

DEVICETransesophageal echocardiography

* D.Echocardiography(Transthoracic and transesophageal): * 2D echocardiography (to detect LA function, severity of MS and Wilkins score). The following conventional parameters were measured : * left atrial volume index (LAVi), and left ventricular ejection fraction (LVEF) by modified biplane Simpson's rule , left atrial emptying fraction calculated as (LAVi max-LAVi min)/LAVi max × 100 ,\]degree of concomitant mitral regurgitation. The maximum and minimum LAA areas were measured by planimetry. LAA area change (%) was calculated using the following formula: LAA area change = \[(maximal LAA area-minimal LAA area)/maximal LAA area\] × 100. * Transesophageal echocardiogram (TEE) (to detect LAA function) . * LAA flow velocity patterns by pulsed-wave Doppler * Early diastolic emptying velocity * Late diastolic emptying velocity or LAA contraction flow * LAA filling velocity * Systolic reflection waves * Two-Dimensional- LAA fractional area change (LAAAC%)

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* • Patient eligible for PTMC as anatomical characteristics àpatient with sever MS (area 1.5cm2, echocardiographic score (Wilkins score ≤ 8, Cormier score 1 and 2 …), contraindication or high risk to surgical MVR.

Exclusion criteria

* Patient with mitral regurgitation more than grade II . * Patient not eligible to PTMC. * Patient with severe heart failure (NHYA class IV) . * Patient with previous Cerebrovascular accident . * Patient with contraindication to TEE ( esophageal disease like stricture , diverticuli, varices, …, uncooperative patient )

Design outcomes

Primary

MeasureTime frameDescription
Impact of Percutaneous Transvenous Mitral Commissurotomy on The Left Atrial Appendage Function in Patients with Mitral Stenosis.baslineAssessment of left atrial appendage function pre and post PTMC. This assessment will be carried out through echocardiography by describing if it contains thrombus or not.

Secondary

MeasureTime frameDescription
Prevention of left atrial appendage thrombus.baslineImprovement of LAA function and its clinical repercussion in preventing thrombus formation and consequently cerebrovascular accidents by follow up LAA function and whether thrombus is formed or not.

Contacts

Primary ContactMohamed Ismail
prep.ismail@gmail.com01091806181
Backup ContactHamdy shames eddin
Ashams98@gmail.com01065601161

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026