Left Atrial Appendage (LAA) Clot With Severe Mitral Stenosis

Mitral Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05186649
• Other study ID #: LAA-Pak-21
• Status: Recruiting
• Start date: December 1, 2021
• Est. completion date: July 15, 2022

Study information

• Verified date: December 2021
• Source: University of Karachi
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: July 15, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Constriction, Pathologic
• Mitral Stenosis
• Mitral Valve Stenosis

Intervention

Other:
• WARFARIN
5 mg of daily dosage

Locations

Country	Name	City	State
Pakistan	Karachi Institute of Heart Disease	Karachi	Sindh

Sponsors (3)

Lead Sponsor	Collaborator
University of Karachi	Advanced Education & Research Center, Karachi Institute of Heart Diseases

Country where clinical trial is conducted

Pakistan, 

References & Publications (6)

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. — View Citation

Mirdamadi A, Mirmohammadsadeghi M, Marashinia F, Nourbakhsh M. Left atrial appendage occlusion. Int J Prev Med. 2013 Jan;4(1):102-4. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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