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Left Atrial Appendage (LAA) Clot With Severe Mitral Stenosis

Left Atrial Appendage (LAA) Clot With Severe Mitral Stenosis, Responders and Non-responders With Anticoagulation

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05186649
Enrollment
52
Registered
2022-01-11
Start date
2021-12-01
Completion date
2022-07-15
Last updated
2022-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Left Atrial Appendage Aneurysm, Mitral Stenosis

Keywords

Mitral Stenosis, Left Atrial Appendage, anticoagulation, echocardiography

Brief summary

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.

Detailed 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.

Interventions

OTHERWARFARIN

5 mg of daily dosage

Sponsors

Advanced Education & Research Center
CollaboratorOTHER
Karachi Institute of Heart Diseases
CollaboratorNETWORK
University of Karachi
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
frequency of left atrial appendage6 MonthTo determine frequency of left atrial appendage (LAA) clot resolution after three months of anticoagulation in patients with severe mitral stenosis.

Secondary

MeasureTime frameDescription
anatomies of LAA6 MonthTo assess the rate of response in different anatomies of LAA so that non-responders can be refer for surgery on the very first TEE examination.

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026