Left Atrial Appendage AneurysmNCT05186649
Left Atrial Appendage (LAA) Clot With Severe Mitral Stenosis
An observational study of Left Atrial Appendage Aneurysm and Mitral Stenosis, run by University of Karachi at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Left Atrial Appendage Aneurysm, Mitral Stenosis
- What is being tested?
- WARFARIN
- How many people
- 52 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Dec 2021to 15 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with clot in left atrial appendage.
Who may be able to join
- 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).
Who cannot join
- Patients with severe MR
- Patients with severe AS
- Patients with NYHA class IV
- Patients whose valve morphology precluded PTMC
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Karachi Institute of Heart Disease
Karachi, Sindh, 78500
Tariq Ashraf, FCPS, 03222999914, tariqash45@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Left Atrial Appendage Aneurysm, Mitral Stenosis
- Being tested
- WARFARIN
- Keywords
- Mitral Stenosis, Left Atrial Appendage, anticoagulation, echocardiography
- Medical subject headings
- Mitral Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WARFARINOther
5 mg of daily dosage
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: WARFARIN |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 Month
Secondary outcomes (1)
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.
Measured: 6 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start1 Dec 2021
- Primary completion30 Jun 2022 (estimated)
- Study completion15 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Left Atrial Appendage AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Karachi
- Sponsor type
- University, hospital or other
- Collaborators
- Advanced Education & Research Center, Karachi Institute of Heart Diseases
- Responsible party
- Principal investigator, Prof. Dr. Tariq Ashraf, University of Karachi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05186649
- Sponsor's protocol ID
- LAA-Pak-21
- Status last verified
- Dec 2021
- First submitted
- 25 Dec 2021
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
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.
PubMed 21702263Mirdamadi A, Mirmohammadsadeghi M, Marashinia F, Nourbakhsh M. Left atrial appendage occlusion. Int J Prev Med. 2013 Jan;4(1):102-4.
PubMed 23411574Taghipour 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.
PubMed 21859646Shibasaki 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.
PubMed 11244757Oryoji 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.
PubMed 8515174Tremeau 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.
PubMed 8678746
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Left Atrial Appendage (LAA) Clot With Severe Mitral Stenosis, Responders and Non-responders With Anticoagulation
- ClinicalTrials.gov ID
- NCT05186649
- Acronym / sponsor ID
- LAA-Pak-21
- Conditions
- Left Atrial Appendage Aneurysm, Mitral Stenosis
- Keywords
- Mitral Stenosis, Left Atrial Appendage, anticoagulation, echocardiography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- University of KarachiUniversity, hospital or other
- Collaborators
- Advanced Education & Research Center, Karachi Institute of Heart Diseases
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 15 Jul 2022 (estimated)
- First posted
- 11 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | – | Other: WARFARINConsecutive 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with clot in left atrial appendage.
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (4 listed)
- Patients with severe MR
- Patients with severe AS
- Patients with NYHA class IV
- Patients whose valve morphology precluded PTMC
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WARFARIN5 mg of daily dosage | Other | Experimental Group |
Primary outcome
frequency of left atrial appendage
Time frame: 6 Month
To determine frequency of left atrial appendage (LAA) clot resolution after three months of anticoagulation in patients with severe mitral stenosis.
1 secondary outcome
anatomies of LAA
Time frame: 6 Month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
- Background: PubMed 21702263Mahmood 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.
- Background: PubMed 23411574Mirdamadi A, Mirmohammadsadeghi M, Marashinia F, Nourbakhsh M. Left atrial appendage occlusion. Int J Prev Med. 2013 Jan;4(1):102-4.
- Background: PubMed 21859646Taghipour 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.
- Background: PubMed 11244757Shibasaki 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.
- Background: PubMed 8515174Oryoji 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.
- Background: PubMed 8678746Tremeau 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.
- Individual participant dataSharing planned: Yes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Left Atrial Appendage Aneurysm and Mitral Stenosis, run by University of Karachi at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
frequency of left atrial appendage (time frame: 6 Month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05186649, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2022.