Clinical trial NCT05687591: Left Atrial Appendage Occlusion With The Amplatzer Amulet Device: The Southeast Asia Observational Study
Official title: Left Atrial Appendage Occlusion With The Amplatzer Amulet Device: The Southeast Asia Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation
Keywords: left atrial appendage occlusion
atrial fibrillation
Amplatzer Amulet
Lead sponsor: Sarawak Heart Centre
Sponsor class: OTHER
Collaborators: name: InnoSignum
name: Abbott
First posted: 2023-01-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Device embolization
timeFrame: 1 year
measure: Device dislocation and device related thrombus
timeFrame: 1 year
measure: Peri-device leak
timeFrame: 1 year
measure: Residual interatrial shunt
timeFrame: 1 year
measure: Mortality
timeFrame: 1 year
measure: Ischemic Stroke and TIA
timeFrame: 1 year
measure: Major adverse bleeding event
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Kuching
country: Malaysia
facility: Sarawak Heart Centre
state: Sarawak
Study officials:
affiliation: Sarawak Heart Centre
name: Dr. Keng Tat Koh, MBBS
role: PRINCIPAL_INVESTIGATOR
References: