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Left Atrial Appendage (LAA) Clot With Severe Mitral Stenosis

U

University of Karachi

Status

Unknown

Conditions

Mitral Stenosis
Left Atrial Appendage Aneurysm

Treatments

Other: WARFARIN

Study type

Observational

Funder types

Other
NETWORK

Identifiers

NCT05186649
LAA-Pak-21

Details and patient eligibility

About

Consecutive patients with severe mitral stenosis and clot in left atrial appendage (LAA) on transesophageal echocardiography fulfilling the inclusion criteria will be recruited for this study. An ACUSON 128-XP echocardiographic system equipped with omniplane and biplane transesophageal probes will be used for this study. TEE followed by CT Angiography will be performed according to the standard procedure after obtaining informed consent.

Full description

Consecutive patients with severe mitral stenosis and clot in left atrial appendage (LAA) on transesophageal echocardiography fulfilling the inclusion criteria will be recruited for this study. An ACUSON 128-XP echocardiographic system equipped with omniplane and biplane transesophageal probes will be used for this study. TEE followed by CT Angiography will be performed according to the standard procedure after obtaining informed consent. Demographic profile of the patients will be recorded like gender and age. And baseline TEE will be interpreted and parameters such as mean MVO (cm2), mean MPG (mmHg), and mean LA size (AP diameter, cm) will be recorded. LAA morphologies will be classified as per the operational definition. All the patients will be put on oral anticoagulation with Warfarin. The international normalized ratio (INR) will be maintained between 2.5 and 3.5. Patients will be prescribed with warfarin initial with 5 mg of daily dosage. Weekly INR monitoring will be performed via weekly calls to each and every patients and their INR level will be obtained. Warfarin daily dosage will be adjusted after every month based on target INR range. Repeat TEE will be performed after three (3) months in all the patients. And presence and absence of clot in different types of LAA will be recorded.

Enrollment

52 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age between 18 to 65 years.
  • Both male and female.
  • Patients with server mitral stenosis.
  • Patients with LAA clot on TEE.
  • Patients prescribed with anticoagulation (warfarin therapy).

Exclusion criteria

  • Patients with severe MR
  • Patients with severe AS
  • Patients with NYHA class IV
  • Patients whose valve morphology precluded PTMC

Trial design

52 participants in 1 patient group

Experimental Group
Description:
Consecutive patients with severe mitral stenosis and clot in left atrial appendage (LAA) on transesophageal echocardiography fulfilling the inclusion criteria will be recruited for this study. An ACUSON 128-XP echocardiographic system equipped with omniplane and biplane transesophageal probes will be used for this study. TEE followed by CT Angiography will be performed according to the standard procedure after obtaining informed consent.
Treatment:
Other: WARFARIN

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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