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

NCT06340997 | Not Yet Recruiting

• 1 other identifier: Mitral Stenosis
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Mitral Stenosis

Outcome Measures

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.

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Secondary Outcomes (1)

• Prevention of left atrial appendage thrombus.

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Study Arms (1)

Patients with mitral stenosis

OTHER

Device: Transesophageal echocardiography

Interventions

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%)

Patients with mitral stenosis

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 )

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Mitral Valve Stenosis

Interventions

Echocardiography, Transesophageal

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Echocardiography; Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Central Study Contacts

Mohamed Ismail

CONTACT

01091806181; prep.ismail@gmail.com

Hamdy shames eddin

CONTACT

01065601161; Ashams98@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: December 14, 2023
• First Posted: April 2, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: April 2, 2024

Record last verified: 2024-03