Left Atrial Appendage Occlusion With The Amplatzer Amulet Device: The Southeast Asia Observational Study

Atrial Fibrillation Clinical Trial

Official title: Left Atrial Appendage Occlusion With The Amplatzer Amulet Device: The Southeast Asia Observational Study

Status Recruiting

Clinical 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Atrial Fibrillation

• NCT number: NCT05687591
• Study type: Observational
• Source: Sarawak Heart Centre
• Contact: Dr. Keng Tat Koh, MBBS
• Phone: 6012-6962212
• Email: keng_tat@hotmail.com
• Status: Recruiting
• Start date: October 1, 2022
• Completion date: October 1, 2024