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

NCT ID: NCT06340997

Last Updated: 2024-04-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2027-08-01

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.

Conditions

Mitral Stenosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Patients with mitral stenosis

Group Type: OTHER

Transesophageal echocardiography

Intervention Type: DEVICE

• 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%)

Interventions

Transesophageal 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%)

Intervention Type: DEVICE

Eligibility Criteria

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 )

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Ahmed Ali Ismail

Resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Mohamed Ismail

Role: CONTACT

prep.ismail@gmail.com

01091806181

Hamdy shames eddin

Role: CONTACT

Ashams98@gmail.com

01065601161

Other Identifiers

Mitral Stenosis

Identifier Type: -

Identifier Source: org_study_id