Left Atrial Appendage (LAA) Clot With Severe Mitral Stenosis

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

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.

Study Overview

• Status: Recruiting
• Conditions: Left Atrial Appendage Aneurysm; Mitral Stenosis
• Intervention / Treatment: Other: WARFARIN

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.

• Study Type: Observational
• Enrollment (Anticipated): 52

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 78500
      • Recruiting
      • Karachi institute of heart disease
      • Contact: Tariq Ashraf, FCPS; Phone Number: 03222999914; Email: tariqash45@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with clot in left atrial appendage.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Experimental Group; 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.

Other: WARFARIN; 5 mg of daily dosage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
frequency of left atrial appendage	To determine frequency of left atrial appendage (LAA) clot resolution after three months of anticoagulation in patients with severe mitral stenosis.	6 Month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
anatomies of LAA	To 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.	6 Month

Collaborators and Investigators

• Sponsor: University of Karachi
• Collaborators: Advanced Education & Research Center; Karachi Institute of Heart Diseases

Publications and helpful links

General Publications

• Mahmood ul Hassan, Hussain C, Gul AM, ullah Jan H, Hafizullah M. Frequency of left atrial and appendage clot in patients with severe mitral stenosis. J Ayub Med Coll Abbottabad. 2010 Apr-Jun;22(2):40-2.
• Mirdamadi A, Mirmohammadsadeghi M, Marashinia F, Nourbakhsh M. Left atrial appendage occlusion. Int J Prev Med. 2013 Jan;4(1):102-4.
• Taghipour HR, Farahani MM, Ghiasi S, Naseri MH, Fakhraddin F. Coincidence of free-floating thrombus in the aortic arch, severe mitral stenosis, and left atrial appendage clot. Heart Surg Forum. 2011 Aug;14(4):E252-4. doi: 10.1532/HSF98.20101147.
• Shibasaki I, Kaneko T, Obayashi T, Sato Y, Inaba H, Kaki N, Ogata T, Oki S. [A case of free-floating ball thrombus in left atrium with mitral stenosis]. Kyobu Geka. 2001 Mar;54(3):228-31. Japanese.
• Oryoji A, Kawara T, Hara H, Aoyagi S, Kosuga K, Ohishi K. [Left atrial free-floating ball thrombus in a patient without mitral valve disease]. Nihon Kyobu Geka Gakkai Zasshi. 1993 Apr;41(4):699-703. Review. Japanese.
• Trémeau G, Chapon P, Buttard P, Gayet C, Oddou B, Nicolai Y, Beurlet J, Guichard G, Milon H. [Left atrial free floating thrombus without mitral valve disease. Review of the literature apropos of a case]. Arch Mal Coeur Vaiss. 1996 Jan;89(1):99-102. Review. French.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Anticipated): June 30, 2022
• Study Completion (Anticipated): July 15, 2022

Study Registration Dates

• First Submitted: December 25, 2021
• First Submitted That Met QC Criteria: December 25, 2021
• First Posted (Actual): January 11, 2022

Study Record Updates

• Last Update Posted (Actual): January 11, 2022
• Last Update Submitted That Met QC Criteria: December 25, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: echocardiography; Left Atrial Appendage; anticoagulation; Mitral Stenosis
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pathological Conditions, Anatomical; Heart Valve Diseases; Constriction, Pathologic; Aneurysm; Mitral Valve Stenosis; Anticoagulants; Warfarin
• Other Study ID Numbers: LAA-Pak-21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No