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

A

Assiut University

Status

Not yet enrolling

Conditions

Mitral Stenosis

Treatments

Device: Transesophageal echocardiography

Study type

Interventional

Funder types

Other

Identifiers

NCT06340997
Mitral Stenosis

Details and patient eligibility

About

• 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.

Full 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.

Enrollment

25 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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 )

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

25 participants in 1 patient group

Patients with mitral stenosis
Other group
Treatment:
Device: Transesophageal echocardiography

Trial contacts and locations

0

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Central trial contact

Mohamed Ismail; Hamdy shames eddin

Data sourced from clinicaltrials.gov

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