NCT05186649

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2021

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

December 25, 2021

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 11, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2022

Completed
Last Updated

January 11, 2022

Status Verified

December 1, 2021

Enrollment Period

7 months

First QC Date

December 25, 2021

Last Update Submit

December 25, 2021

Conditions

Left Atrial Appendage AneurysmMitral Stenosis

Keywords

Mitral StenosisLeft Atrial Appendageanticoagulationechocardiography

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • anatomies of LAA

    6 Month

Study Arms (1)

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

Interventions

WARFARINOTHER

5 mg of daily dosage

Experimental Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with clot in left atrial appendage.

You may qualify if:

  • 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).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karachi Institute of Heart Disease

Karachi, Sindh, 78500, Pakistan

RECRUITING

Related 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.

    PMID: 21702263BACKGROUND

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

    PMID: 23411574BACKGROUND

  • 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.

    PMID: 21859646BACKGROUND

  • 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.

    PMID: 11244757BACKGROUND

  • 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. Japanese.

    PMID: 8515174BACKGROUND

  • Tremeau 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. French.

    PMID: 8678746BACKGROUND

MeSH Terms

Conditions

Mitral Valve Stenosis

Interventions

Warfarin

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

4-HydroxycoumarinsCoumarinsBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 25, 2021

First Posted

January 11, 2022

Study Start

December 1, 2021

Primary Completion

June 30, 2022

Study Completion

July 15, 2022

Last Updated

January 11, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF

Locations

PA(1)