Ignite Creation Date:
2024-05-06 @ 6:29 PM
Last Modification Date:
2024-10-26 @ 2:49 PM
Study NCT ID:
NCT05687591
Status:
RECRUITING
Last Update Posted:
2023-01-27
First Post:
2023-01-02
Brief Title:
Left Atrial Appendage Occlusion With The Amplatzer Amulet Device The Southeast Asia Observational Study
Sponsor:
Sarawak Heart Centre
Organization:
Sarawak Heart Centre
Study Overview
Official Title:
Left Atrial Appendage Occlusion With The Amplatzer Amulet Device The Southeast Asia Observational Study
Status:
RECRUITING
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Fishers 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
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 Fishers 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None