NCT05687591Completed
Left Atrial Appendage Occlusion With The Amplatzer Amulet Device: The Southeast Asia Observational Study
Source: ClinicalTrials.gov · Last updated 25 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 104 (actual)
- First submitted
- 2 Jan 2023
- Start date
- 1 Oct 2022
- Primary completion date
- 1 Dec 2024
- Lead sponsor
- Sarawak Heart Centre
- Diseases
- Atrial fibrillation
- NCT number
- NCT05687591
What you commit to
- Study type: Observational
- Participants enrolled: 104
- From 1 Oct 2022 to the primary completion date, 1 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Actively enrolled or plans to enroll in a concurrent clinical study in which the active treatment arm may confound the results of this trial
Other illness
- With active endocarditis or other infections producing bacteremia
- 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
- 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.
Other
- Where placement of the device would interfere with any intracardiac or intravascular structures
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sarawak Heart Centre Coordinator of this site? Confirm its status | Kuching | Malaysia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.