Atrial FibrillationNCT05687591
Left Atrial Appendage Occlusion With The Amplatzer Amulet Device: The Southeast Asia Observational Study
An observational study of Atrial Fibrillation, run by Sarawak Heart Centre at 1 site in Malaysia.
Trial summary
This is a prospective and retrospective, multicenter observational study where the study is being performed to explore on the short-term and long-term safety and efficacy of LAA occlusion with Amplatzer Amulet Device in Southeast Asia population on a real-world basis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Amplatzer Amulet Left Atrial Appendage Occlusion Device
- Type of treatment
- Medical device
- How many people
- 104 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Oct 2022to 1 Dec 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The subjects who are indicated for LAAO with the Amplatzer Amulet are eligible for the study. Subjects who had their occluder implanted, been recently implanted or intended to undergo the procedure may be considerd to participate in the study.
Who may be able to join
- 18 year of age or older
- Documented paroxysmal, persistent, or permanent non-valvular atrial fibrillation
- At high risk of stroke or systemic embolism defined as CHA2DS2-VASc score of more than or equal to 3
- Deemed suitable for LAA occlusion by the treating physician, who might or might not be the investigator
- Able to comply with the required medication regimen post-device implant
- Able and willing to return for required follow-up visits and examinations
Who cannot join
- With active endocarditis or other infections producing bacteremia
- Where placement of the device would interfere with any intracardiac or intravascular structures
- Reversible cause of AF (i.e. secondary to thyroid disorders, acute alcohol intoxication, trauma, recent major surgical procedures)
- Hypersensitivity to any portion of the device material or individual components of the Amulet LAA closure device
- Actively enrolled or plans to enroll in a concurrent clinical study in which the active treatment arm may confound the results of this trial
- Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the patient's ability to participate in the clinical trial or to comply with follow up requireemnts, or impact the scientific soundness of the clinical trial results.
Trial locations and contacts
1 site in 1 country.
About this study
This is a prospective and retrospective, multicenter observational study where the study is being performed to explore on the short-term and long-term safety and efficacy of LAA occlusion with Amplatzer Amulet Device in Southeast Asia population on a real-world basis.
Read the detailed description
The study is both retrospective and prospective, multicenter observational study for all patient indicated for LAAO with the Amplatzer Amulet device, involving subjects who had their occluder implanted, been recently implanted or intended to undergo the procedure may be considerd to participate in the study. The sample size is 100 and is based on the estimated number of recruitments from the participating centers. The study duration is 12 months of recruitment plus 1 year follow-up for outcomes. The outcomes are measured based on the objectives of the study:
Primary objective:
To explore on the short-term and long-term (1 year) safety and efficacy of LAA occlusion with the Amplatzer Amulet Device in Southeast Asia population on a real-world basis.
Secondary objective:
To compare the practice of LAA occlusion with Amplatzer Amulet Device in Southeast Asia population with the European registries.
Exploratory objective:
To explore the cost effectiveness of LAA occlusion with the Amplatzer Amulet Device in the Southeast Asia.
Descriptive statistics includes percentage, mean with standard deviation, or median with interquartile range will be reported, whichever appropriate. Categorical variables will be analysed using chi-square test or Fisher's exact test. Continuous variables will be analysed using independent (two variables only) or ANOVA test (more than two variables), or Mann-Whitney test (two variables only) or Kruskal-Wallis test (more than two variables) depending on the nature of underlying distributions. Time dependent outcome data will be analysed using Kaplan-Meier survival analysis.
- Conditions
- Atrial Fibrillation
- Being tested
- Amplatzer Amulet Left Atrial Appendage Occlusion Device
- Keywords
- left atrial appendage occlusion, atrial fibrillation, Amplatzer Amulet
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amplatzer Amulet Left Atrial Appendage Occlusion DeviceDevice
The Amplatzer Amulet LAAO is a transcatheter, self-expanding device intended for use in preventing thrombus embolization from the left atrial appendage. The device is constucted from a nitinol mesh and consists of a lobe and a disc connected by a central waist. Polyester patches are sewn into both the lobe and disc to facilitate occlusion. The lobe has stabilizing wires to improve device placement and retention. The device has threaded screw attachments at each end for connection to the delivery and loading cables. The device has radiopaque markers at each end and at the stabilizing wires that permit visibility during fluoroscopy.
| Study group | Role | What they receive |
|---|---|---|
| Patients indicated for LAAO with the Amplatzer Amulet | All subjects who are indicated for LAAO with the Amplatzer Amulet are eligible for the study. Receives: Device: Amplatzer Amulet Left Atrial Appendage Occlusion Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device embolization
To determine if device embolization occurs (Yes/No). This is visualized through TOE or CT scan or TOE and CT scan
Measured: 1 year
Device dislocation and device related thrombus
To determine if there is any device-associated thrombus occurs after the implantation of the occluder (Presence/Absence). This is visualized through TOE or CT scan or TOE and CT scan.
Measured: 1 year
Peri-device leak
To determine if there is peri-device leak occurs after the implantation of the occluder (Yes/No). This is visualized through TOE or CT scan or TOE and CT scan.
Measured: 1 year
Residual interatrial shunt
To determine if there is residual interatrial shunt occurs after the implantation of the occluder (Yes/No). This is visualized through TOE or CT scan or TOE and CT scan.
Measured: 1 year
Mortality
To determine the mortality at 1 year after LAA occluder implantation
Measured: 1 year
Ischemic Stroke and TIA
To determine the rate of ischemic stroke and TIA at 1 year after LAA occluder implantation
Measured: 1 year
Major adverse bleeding event
To determine the rate of major adverse bleeding event at 1 year after LAA occluder implantation
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2023
- Study start1 Oct 2022
- Primary completion1 Dec 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies 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
- Case only
- Time perspective
- Other
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sarawak Heart Centre
- Sponsor type
- University, hospital or other
- Collaborators
- InnoSignum, Abbott
- Responsible party
- Principal investigator, Dr. Keng Tat Koh, Sarawak Heart Centre
- Investigators
- Dr. Keng Tat Koh, MBBS, Principal investigator, Sarawak Heart Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05687591
- Sponsor's protocol ID
- Amulet-SEA-01
- Status last verified
- Feb 2026
- First submitted
- 2 Jan 2023
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Left Atrial Appendage Occlusion With The Amplatzer Amulet Device: The Southeast Asia Observational Study
- ClinicalTrials.gov ID
- NCT05687591
- Acronym / sponsor ID
- Amulet-SEA-01
- Conditions
- Atrial Fibrillation
- Keywords
- left atrial appendage occlusion, atrial fibrillation, Amplatzer Amulet
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Sarawak Heart CentreUniversity, hospital or other
- Collaborators
- InnoSignum, Abbott
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 18 Jan 2023 (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.
This is a prospective and retrospective, multicenter observational study where the study is being performed to explore on the short-term and long-term safety and efficacy of LAA occlusion with Amplatzer Amulet Device in Southeast Asia population on a real-world basis.
Detailed description
The study is both retrospective and prospective, multicenter observational study for all patient indicated for LAAO with the Amplatzer Amulet device, involving subjects who had their occluder implanted, been recently implanted or intended to undergo the procedure may be considerd to participate in the study. The sample size is 100 and is based on the estimated number of recruitments from the participating centers. The study duration is 12 months of recruitment plus 1 year follow-up for outcomes. The outcomes are measured based on the objectives of the study:
Primary objective:
To explore on the short-term and long-term (1 year) safety and efficacy of LAA occlusion with the Amplatzer Amulet Device in Southeast Asia population on a real-world basis.
Secondary objective:
To compare the practice of LAA occlusion with Amplatzer Amulet Device in Southeast Asia population with the European registries.
Exploratory objective:
To explore the cost effectiveness of LAA occlusion with the Amplatzer Amulet Device in the Southeast Asia.
Descriptive statistics includes percentage, mean with standard deviation, or median with interquartile range will be reported, whichever appropriate. Categorical variables will be analysed using chi-square test or Fisher's exact test. Continuous variables will be analysed using independent (two variables only) or ANOVA test (more than two variables), or Mann-Whitney test (two variables only) or Kruskal-Wallis test (more than two variables) depending on the nature of underlying distributions. Time dependent outcome data will be analysed using Kaplan-Meier survival analysis.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients indicated for LAAO with the Amplatzer Amulet | – | Device: Amplatzer Amulet Left Atrial Appendage Occlusion DeviceAll subjects who are indicated for LAAO with the Amplatzer Amulet are eligible for the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The subjects who are indicated for LAAO with the Amplatzer Amulet are eligible for the study. Subjects who had their occluder implanted, been recently implanted or intended to undergo the procedure may be considerd to participate in the study.
Key inclusion criteria (6 listed)
- 18 year of age or older
- Documented paroxysmal, persistent, or permanent non-valvular atrial fibrillation
- At high risk of stroke or systemic embolism defined as CHA2DS2-VASc score of more than or equal to 3
- Deemed suitable for LAA occlusion by the treating physician, who might or might not be the investigator
- Able to comply with the required medication regimen post-device implant
Key exclusion criteria (6 listed)
- With active endocarditis or other infections producing bacteremia
- Where placement of the device would interfere with any intracardiac or intravascular structures
- Reversible cause of AF (i.e. secondary to thyroid disorders, acute alcohol intoxication, trauma, recent major surgical procedures)
- Hypersensitivity to any portion of the device material or individual components of the Amulet LAA closure device
- Actively enrolled or plans to enroll in a concurrent clinical study in which the active treatment arm may confound the results of this trial
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 |
|---|---|---|
| Amplatzer Amulet Left Atrial Appendage Occlusion DeviceThe Amplatzer Amulet LAAO is a transcatheter, self-expanding device intended for use in preventing thrombus embolization from the left atrial appendage. The device is constucted from a nitinol mesh and consists of a lobe and a disc connected by a central waist. Polyester patches are sewn into both the lobe and disc to facilitate occlusion. The lobe has stabilizing wires to improve device placement and retention. The device has threaded screw attachments at each end for connection to the delivery and loading cables. The device has radiopaque markers at each end and at the stabilizing wires that permit visibility during fluoroscopy. | Device | Patients indicated for LAAO with the Amplatzer Amulet |
Primary outcome
Device embolization
Time frame: 1 year
To determine if device embolization occurs (Yes/No). This is visualized through TOE or CT scan or TOE and CT scan
Device dislocation and device related thrombus
Time frame: 1 year
To determine if there is any device-associated thrombus occurs after the implantation of the occluder (Presence/Absence). This is visualized through TOE or CT scan or TOE and CT scan.
Peri-device leak
Time frame: 1 year
To determine if there is peri-device leak occurs after the implantation of the occluder (Yes/No). This is visualized through TOE or CT scan or TOE and CT scan.
Residual interatrial shunt
Time frame: 1 year
To determine if there is residual interatrial shunt occurs after the implantation of the occluder (Yes/No). This is visualized through TOE or CT scan or TOE and CT scan.
Mortality
Time frame: 1 year
To determine the mortality at 1 year after LAA occluder implantation
Ischemic Stroke and TIA
Time frame: 1 year
To determine the rate of ischemic stroke and TIA at 1 year after LAA occluder implantation
Major adverse bleeding event
Time frame: 1 year
To determine the rate of major adverse bleeding event at 1 year after LAA occluder implantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
Related trials for Atrial Fibrillation
RecruitingPhase 3
Stroke and Systemic Embolism Prevention in Adult Participants With Atrial Fibrillation
Atrial Fibrillation (AF)
Not yet recruiting
Partial Cardiac Denervation for Preventing Atrial Fibrillation After CABG
Postoperative Atrial Fibrillation, Coronary Artery Disease
Recruiting
Peer-Mentor Support for Vulnerable Patients With Atrial Fibrillation
Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
Not yet recruitingObservational study
Hummingbird ICE Study
ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION, Atrial Fibrillation (AF)
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.
Dr. Keng Tat Koh, MBBS principal investigator
Sarawak Heart Centre
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 Atrial Fibrillation, run by Sarawak Heart Centre at 1 site in Malaysia.
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 6 inclusion and 6 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: finished, as of the sponsor's last update on 25 Feb 2026. 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 Malaysia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device embolization (time frame: 1 year). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Feb 2026.