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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorAssiut University

About this trial

• 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

• 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.

Disqualifiers

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 .

Trial design

Design model

Single group

Treatments tested in this trial

  • Transesophageal echocardiography

    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%)

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: Patients with mitral stenosisOther 1 intervention

Trial outcomes

Primary outcomes

1

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

Assessment 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.

Time frame
basline

Secondary outcomes

1

Prevention of left atrial appendage thrombus.

Improvement 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.

Time frame
basline

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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